StemCell Therapy

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Randy Liebich curled up in a ball on his bed inside Stateville prison, about an hour outside Chicago. It was June 2010, and hed spent the night in a cold sweat, excruciating pain radiating from his back. For months, hed been filing complaints with prison officials about the lack of medical care. But the forms, known as grievances, got him nowhere.

One was denied, in part because hed already been to the doctor, and the denial noted hed received acetaminophen pain medication. Another complaint was deemed moot.

Now Liebich was in the worst pain of his life. According to medical records, a kidney stone had made it impossible for him to urinate. The men in nearby cells shouted for help.

Correctional officers took Liebich to the medical office, where, records show, a doctor used a hemostat, a tweezer-like surgical tool, to try to remove the stone through the tip of Liebichs penis. But the procedure failed, leaving the stone intact. About six hours passed that day before Liebich was driven to an outside hospital for emergency surgery.

When Liebich got back to the prison, he filed two more grievances about the poor medical treatment hed received. If staff had addressed his earlier complaints, he wrote, he could have avoided the procedure with the hemostat altogether. But prison officials denied those grievances too.

Liebich filed over a dozen more grievances related to his kidney condition over the next eight years, until a judge threw out his murder conviction in 2018 after finding his lawyers ignored key evidence. Prosecutors later dropped all charges, but Liebich says he still suffers trauma from his experience with the hemostat.

People locked inside prisons rely on grievances to complain if their needs, from health care to sanitation to safety, are unmet. The complaints are among their few means of recourse. But in Illinois, that system is sputtering, with little oversight, leaving prisoners vulnerable to harm, an investigation by WBEZ and ProPublica has found.

The state has paid millions to settle the claims of inmates, some of whom raised concerns early through grievances, only to later suffer serious injuries when authorities denied complaints or failed to act.

In one case, a prisoner at Stateville Correctional Center filed a grievance to complain about roaches crawling over him as he slept. He also said he had extreme pain in his ear and heard constant crackling. But he said his complaints were ignored by prison staff. Two weeks after his grievance, records show medical workers removed a bug from his ear. He later filed a lawsuit, alleging ear pain and hearing loss. The case was settled for $12,500, three and a half years after the first grievance. The state denied wrongdoing.

In another case, a man at Stateville spent months filing grievances and writing letters to prison officials about a protruding bolt near his bunk bed. The warden denied the grievances, because theyd been filed as emergencies, and he disagreed with the classification. Eight months after the prisoners initial complaint, he fell out of his bed and hit his eye on the bolt, resulting in disability and disfigurement, according to a lawsuit he filed. Records show he was treated by a doctor the same day. The state disputed the mans claims in court documents, but the parties agreed to a settlement in which the state paid the inmate $70,000.

In Liebichs case, he filed a lawsuit over the medical treatment he received and alleged that prison staff retaliated against him for complaining. The state denied wrongdoing but agreed to a settlement of $70,000.

The Illinois prison system, which had an average daily population of about 40,000 people last year, is now under federal oversight as part of a legal agreement to improve health care in state prisons. A court-appointed expert found in 2018 that the medical care was so poor that people were needlessly dying.

Because grievances can serve as early warnings for prison administrators about dangerous conditions, experts say tracking the complaints is critical.

But WBEZ and ProPublica found Illinois is faltering. The news organizations requested five years of data from the 15 largest prisons, showing the number of grievances and how they were resolved. Only seven were able to provide information that was complete enough to analyze. Some institutions had an entire year of data missing.

Of the grievances that were reviewed by prison officials, about 5% were decided in part, or in whole, in a prisoners favor. Inmates can appeal to a Department of Corrections review board, but the approval rate there was similar, the WBEZ-ProPublica analysis found.

States have different methods of tracking grievances, and its difficult to compare Illinois system to other jurisdictions, but experts said the findings suggest its not working as it should.

With a rate that low, it just seems like nobody believes in the system, said Dan Pacholke, former administrator for the Washington State Department of Corrections and co-author of a book on prison safety. It would certainly be concerning for me as a superintendent of a prison.

Others were more blunt.

What we have here is sort of the fox watching the henhouse, said Jenny Vollen-Katz, executive director of the John Howard Association, an independent citizen group that has monitored Illinois prisons for more than a century.

WBEZ and ProPublica sought an interview with state corrections officials over the course of four months, but the department declined multiple requests. In a written response, it said the approval rate appeared artificially low, in part, because of prolific grievance filers and frivolous complaints. It also noted that many grievances are resolved informally by counselors; about 13% of grievances in the analysis were withdrawn by the inmate before an official review.

Still, in response to a detailed outline of our findings, corrections officials said they were pursuing a number of measures to improve the grievance system, including plans to hire a chief inspector to oversee the statewide system. Officials also said the department would be transitioning to electronic grievances, a move that would make the system more efficient and data easier to track.

The operation of a fair and consistent grievance process is a high priority for the Department, and we are working diligently to improve the current system, the department said in the statement. Through the implementation of significant reforms and an increase in oversight, we can ensure the concerns of men and women in custody are addressed in a timely manner.

Prison watchdog groups and some lawmakers lauded the changes, but they said Illinois system needs a bigger overhaul with more oversight. Some are pushing a proposal to create an ombudsman that would investigate complaints about the department.

Illinois State Rep. La Shawn Ford, a Democrat and former head of the House Restorative Justice Committee, said family members of people in prison regularly call his office asking for help with a grievance. He commended the departments proposed changes but said officials need to make sure that theres a process in place that will allow for the best outcomes for the people making grievances.

You cannot be the judge and the jury and the prosecutor.

In the fall of 1971, nearly 1,300 prisoners took over Attica Correctional Facility in New York to protest abuse and poor living conditions. It was one of the most violent prison standoffs in U.S. history, leaving 43 people dead. Over the next few years, other prison uprisings broke out across the country, as the prison rights movement grew. A report from the U.S. Department of Justice said the lack of grievance systems had probably made these incidents inevitable, because prisoners had no other way to get their needs heard.

Toussaint Losier, a professor of Afro-American studies at the University of Massachusetts-Amherst who has studied American prisons, said grievance systems emerged in this era to create a safety valve to let off some of the steam that could build up over time. But states also had another incentive. Lawsuits filed by prisoners were clogging the federal court system; by 1974, 1 in 20 civil cases filed in federal court were prison civil rights cases, according to Margo Schlanger, a professor of civil rights law at the University of Michigan and a leading expert on prison litigation. Federal judges called for another venue to evaluate complaints. As one put it, if prisoners had a fair alternative, theyd choose that over the delayed process of the courts.

But even after states created grievance systems, the deluge of lawsuits continued. A study from the early 1980s found people incarcerated at two Illinois prisons thought the states grievance system was wholly institution controlled and rarely yielding favorable or even impartial results.

To stem the tide of lawsuits, Congress passed the Prison Litigation Reform Act, or PLRA, in 1996. The legislation made grievances critical by requiring inmates to exhaust the prisons internal grievance system before filing a lawsuit. A co-sponsor of the bill, Sen. Strom Thurmond, R-S.C., said it would prevent frivolous and malicious lawsuits filed by prison inmates. Opponents, including then-Sen. Joe Biden, D-Del., argued the bill unwisely limited the courts power to protect the constitutional rights of people behind bars. The results of the law were striking. The number of lawsuits filed per prisoner shrank by more than 50% over the next two decades, according to Schlanger.

But thats not because prisoners problems were suddenly being addressed through grievances. In fact, some experts say the PLRA may have actually made grievance systems worse. After the law passed, some corrections officials raised administrative hurdles for the complaints, and in doing so made it harder to file lawsuits. Schlanger said prison officials in some states threw out grievances for tiny technical violations, like writing in the wrong color ink.

In Illinois, the state Department of Corrections reduced the window of time within which prisoners can file most grievances from six months to 60 days. It also limited outside oversight of appeals, eliminating a rule that required at least one review board member to come from outside the department. The agency did not respond to a question about the changes.

But officials did note that one reason the approval rate of grievances is so low is because prisoners make technical mistakes, like missing a deadline.

There was a huge incentive to make the grievance process as complicated and as impossible to complete properly as they could, said Alan Mills, a lawyer and executive director of the Uptown Peoples Law Center who has spent decades representing prisoners in Illinois.

Instead of protecting prisoners rights, Mills said grievance systems instead work to protect the department and its employees from lawsuits. In 2011, Mills was part of a team that filed a class-action lawsuit on behalf of deaf and hard of hearing prisoners who werent getting hearing aids or access to interpreters. The plaintiffs argued that they were unable to participate in education programs, stay in contact with loved ones or discuss medical issues with doctors. Mills estimates it took lawyers 18 months to figure out how to exhaust the grievance process so they could move forward with the lawsuit. For example, Mills said, sometimes prison officials would only respond to one issue in a grievance even if a prisoner had listed several issues. This made it unclear if the other issues had been denied, ignored or granted leaving the prisoner unsure if they needed to file additional grievances.

This is 10 extremely qualified, experienced lawyers trying to figure out how to navigate this process. Imagine what somebody who dropped out of sixth grade and is sitting in a jail cell with no resources at all; how they can ever figure out how to make it through that process? Mills said.

The lawsuit later settled with the state agreeing to provide accommodations for deaf and hard of hearing prisoners.

In the spring of 2011, officers at Lincoln Correctional Center ordered about 200 women out of their housing unit. Wielding batons and shields, officers marched the prisoners into a gymnasium and conducted a series of strip-searches, according to a lawsuit the women filed in federal court.

The women were then forced to spread their buttocks and vaginas in view of male staff, and officers made derogatory comments about their bodies, according to the lawsuit. The women, who alleged the search constituted cruel and unusual punishment, also said they were forced to remove tampons and bled on themselves while they waited for others to be searched.

A lawyer for the Department of Corrections denied those claims of mistreatment and said the search was necessary to keep the facility safe from contraband. A jury decided against the prisoners, but the women appealed on different constitutional grounds and that case is ongoing.

Dozens of the women said they filed grievances over the strip-search. But as time passed, many didnt get an answer. Later, the nonprofit John Howard Association conducted a monitoring visit to the prison. According to its report, the group said it heard a significant number of consistent, unsolicited, and independent reports about the strip-search and missing grievances. But the group said that when it asked prison administrators about it, they could not locate a single grievance related to the incident. Nevertheless, the nonprofits report said officials there acknowledged problems with the grievance system and said they made changes to improve tracking.

Maggie Burke, a former state corrections official who retired as warden of Logan Correctional Center in 2017, said grievances routinely disappeared. If it was just an occasional my grievance disappeared, I would think that it was someone who was exaggerating, she said, adding, But it happened a lot.

The problem was so bad that when she became the statewide coordinator for women and family services within the department about two years after the strip-search incident she added locked boxes that only she and her assistant could access. That gave prisoners a direct and more secure way to express concerns or send her grievances.

The system is critical, Burke said, because people may act out violently or create other problems when their grievances arent addressed.

Dwaine Coleman said thats what he did while incarcerated at Vienna Correctional Center in 2014 for marijuana possession. He complained of excruciating back pain, and prison records show he had previously been diagnosed with sciatica. But he said a doctor did little more than tell him to eat well and exercise. So he filed a grievance asking to see another doctor.

A month passed before a corrections counselor wrote that the care Coleman was receiving was appropriate, and the grievance went up the chain of command. Two weeks later, he had yet to get a decision from the warden. Desperate to grab the attention of senior prison officials, Coleman tied his prison-issued bed sheet in knots and began flushing it, bit by bit, down the toilet. The water gushed over the bowl, flooding his cell, according to court records.

The grievance system is a joke. So you kind of have to act out to get your needs met, Coleman said in an interview. When you start to act out, there are incident reports that have to be sent all around, and now theres a paper trail and a lot more people are getting involved.

Coleman said his attempts backfired though and tensions between him and the staff continued to escalate. A few days after the toilet incident, Coleman said he got into an argument with a correctional officer during a medical evaluation, according to a lawsuit he filed. On the way back from the health care unit, Coleman alleged, the officer rammed his head into a doorway. A dental record from about two weeks later shows a chipped tooth. During a civil trial, the officer denied assaulting him. But a jury decided in Colemans favor and awarded him $35,000 in punitive damages.

Coleman did eventually get a decision from the warden on his health care grievance three months after he filed it. The complaint was denied, saying the care he received was appropriate.

Few prisoners in Illinois have faith in the grievance system. Just 5% considered it effective, according to a 2019 survey by the John Howard Association, which collected responses from 12,780 prisoners across the state. And only 13% said they felt comfortable filing a grievance.

The biggest reason that people dont feel comfortable is fear of retaliation, said Vollen-Katz, executive director of the watchdog group.

After Liebich filed grievances complaining about the poor medical care hed received for his kidney stone, he said staff began to view him as a nuisance. In January 2011, officers came to his cell and, according to court records, insisted that he give a urine sample for a drug test.

Liebich told the correctional officers that his kidney condition made that difficult. Officers told him that if he didnt urinate in the next two hours hed be sent to the hole, officially known as segregation. Its a part of the facility where prisoners are sent as punishment, infamous for being filthy, full of bugs and vermin. (In fact, the conditions were so bad that officials shut down that section of the prison in 2016, though it was reopened for COVID-19 quarantining this year.) For Liebich, the pressure to provide a urine sample felt immense. So, with minutes left to his deadline, he asked if he could have more time.

The guards refused and took him to segregation, according to prison records. Because staff knew his trouble with urination, he believes the whole incident was meant to punish him for filing grievances.

Liebichs lawyer sent emails to the warden, letting him know about Liebichs medical condition. But according to records provided by the lawyer, the warden responded that Liebich would need to address his problem through the grievance process.

Five days after the drug test incident, Liebich filed a complaint over being sent to segregation. The officer that reviewed his grievance recommended the warden approve it, according to prison records, but the warden disagreed and Liebich remained in segregation. Still, in August 2011, Liebich pressed forward with a lawsuit alleging poor medical treatment and retaliation. In court documents, prison officials agreed that Liebich was sent to segregation for failure to provide a urine sample, but they denied that officers were acting in retaliation.

The state agreed to a settlement of $70,000 in January 2015, four years after Liebich filed his grievance over his punishment.

Civil rights lawyers, former prison administrators and prisoners say the only way more people behind bars will get their concerns addressed is with independent oversight and increased transparency.

Currently, the entire grievance process is overseen by the Corrections Department.

Grievances first go to a counselor who attempts to resolve the complaint. If they cannot, a grievance officer evaluates the case and makes a recommendation to the warden, who renders a decision. If a prisoner is dissatisfied with the response, they can send their complaint to a statewide board that reviews grievance appeals called the Administrative Review Board.

The whole process can be time consuming.

The state Corrections Department would not say if it had any data showing the speed at which prisons resolved grievances. Records, however, suggest that many complaints were reviewed slowly, or not at all. Over a third of appeals were thrown out because the prisoner had already been released or died by the time the review board evaluated them.

Of those that were reviewed, 7% were found partially or wholly in favor of the prisoner. The panel evaluates thousands of grievances a month. Complaints can range from a missing radio to guard abuse.

When youre seeing that many grievances, its easy to go, Yeah. OK. You know, that one I dont really have time for, said Joni Stahlman, former assistant deputy director of the womens division who sat on the Administrative Review Board in the early 2000s. Theres that tricky line of fairness and getting the work done.

Prison advocates point to a more fundamental issue though: While the four members of the board do not work at any individual prison, they are still employed by the Corrections Department and appointed by the director. Sitting on the current board are two members who previously worked clerical jobs within the department and one who formerly worked inside a prison as a correctional counselor. Vollen-Katz, of the John Howard Association, said thats not true independence. We are asking a closed system to police itself, she said.

Vollen-Katz said one step the state could take would be to create a corrections ombudsman who could investigate complaints and find solutions. Mills, the civil rights lawyer, agreed, saying the Illinois Department of Juvenile Justice already has such a person who gets copies of all the grievances so that they can track them, find trends, figure out problems, and then bring them to the attention of the department to fix.

An ombudsman in the adult system, he said, would be a huge, huge step forward.

In order for it to be effective, though, the position would need complete autonomy, enforcement capabilities and the power to share information with lawmakers and the public, advocates said. Other states, like New Jersey and Washington, already have a corrections ombudsman, and last year Illinois state lawmakers submitted a bill to create one. But the legislation stalled.

Illinois State Rep. Rita Mayfield, who co-sponsored the ombudsman bill, said she planned to revive the legislation next year. She said one of her central motivations was discovering and fixing problems before they become expensive lawsuits.

What can we do to reduce these losses? What is wrong with the system? What can we correct to better utilize those tax dollars? Mayfield said. The Department of Corrections would not answer questions about its stance on an ombudsman.

Losier, the professor who has studied prisons, said another key change to the grievance system should be more transparency. New York state, for example, issues yearly reports on what types of grievances are filed and how the department handles them. That allows the public and lawmakers to monitor whats happening inside. But Illinois issues no such report.

New Yorks Corrections Department also maintains a database that tracks staff involved in misconduct and abuse claims, so the department can look for patterns. But in Illinois, despite records showing staff misconduct is one of the largest issues for prisoners, the department doesnt track grievances by guard name.

Burke, the former warden, said that having that information, even internally, would be helpful. If we have, you know, 90% of our grievances are on one person, then we know that theres a problem there.

Pacholke, the former administrator for the Washington State Department of Corrections, agreed, saying data collection is critical. If youre not tracking it, the next thing you know, something really horrific or tragic can happen, he said.

Neither the Corrections Department nor AFSCME, the union that represents most front-line corrections staff, responded to questions about the potential of tracking complaints about correctional officers.

In Liebichs case, problems within the prison persisted.

In January 2018, after his lawsuit was settled, the staff decided to test him for drugs again, according to discipline records. When he couldnt provide a urine sample, officers sent him back to segregation.

They just went through this with me. They know I have these medical issues, Liebich said in an interview. They know I had a civil suit about it, and they turn around and they did the same thing to me again.

Liebich spent his days in a cramped cell. The prison allowed inmates to leave their cells for mental health groups. Liebich said sessions were held in the former execution area, from when Illinois had the death penalty.

You can literally feel the hairs on your arms and your neck stand up, Liebich said. He felt powerless.

In January 2019, Liebich filed a second lawsuit against the prison over retaliation. Later that year the state agreed to settle and paid him $25,000, but denied wrongdoing.

Today, he said he still has nightmares about his time inside segregation.

Its frightening to think that they can do this to us and get away with it, Liebich said, and theres nobody that we can really go to for help.

WBEZ and ProPublica are investigating oversight in Illinois prisons. Please get in touch with reporter Shannon Heffernan if you have something to share about:

Violence and safety inside Illinois prisons

Staff conduct and oversight

Prisoner discipline

Internal affairs operations

You can reach her via email: sheffernan@wbez.org or phone: 312-893-2937

Shannon Heffernan is a criminal justice reporter for WBEZ. Email Heffernan at sheffernan@wbez.org and follow her on Twitter at @shannon_h.

Claire Perlman and Alex Mierjeski contributed research and Agnel Philip contributed data reporting.

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From Roaches To Medical Emergencies, Illinois Inmates Say Theres Nobody That We Can Really Go To For Help - WBEZ

BOSTON--(BUSINESS WIRE)--Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that the European Commission (EC) has approved the new 100 mg/mL intravenous (IV) formulation of ULTOMIRIS (ravulizumab) for the treatment of two ultra-rare diseases paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). ULTOMIRIS is the first and only long-acting C5 inhibitor administered to patients every eight weeks or every four weeks for pediatric patients less than 20 kg. ULTOMIRIS 100 mg/mL is an advancement in the treatment experience for patients with aHUS and PNH by reducing average annual infusion times by approximately 60 percent compared to ULTOMIRIS 10 mg/mL, while delivering comparable safety and efficacy. With ULTOMIRIS 100 mg/mL, most patients will spend six hours or less a year receiving treatment.

ULTOMIRIS has already provided patients with greater flexibility and this new formulation is another step forward in reducing the overall treatment burden, said Professor Alexander Rth, Department of Hematology and Stem Cell Transplantation, University Hospital Essen, Essen, Germany. With this new formulation, patients will experience comparable safety and efficacy to the original formulation while spending significantly less time per year receiving treatment, which has the potential to make a meaningful difference in their lives.

PNH is a blood disorder characterized by complement-mediated destruction of the red blood cells that can cause a wide range of debilitating symptoms and complications, including thrombosis, which can occur throughout the body, and result in organ damage and premature death.1 Atypical HUS can cause progressive injury to vital organs, primarily the kidneys, via damage to the walls of blood vessels and blood clots.2 Affecting both adults and children, aHUS patients can present in critical condition, often requiring supportive care, including dialysis, in an intensive care unit. The prognosis of both aHUS and PNH can be poor in many cases, so a timely and accurate diagnosisin addition to appropriate treatmentis critical to improving patient outcomes.

The European Commissions approval of ULTOMIRIS in this new formulation will provide a meaningful benefit to patients quality of life, said John Orloff, M.D., Executive Vice President and Head of Research & Development at Alexion. This new formulation demonstrates Alexions continued commitment to innovating for patients and their families. In addition, it lessens the overall burden on healthcare systems and practitioners with reduced infusion times, and on patients, who will only spend six hours or less a year receiving their treatment.

The European Commission approval is based on a comprehensive chemistry, manufacturing and control submission and a supplementary clinical data set showing that the safety, pharmacokinetics and immunogenicity following administration of ULTOMIRIS 10 mg/mL and ULTOMIRIS 100 mg/mL were comparable. Similarly, the data set showed no relevant changes in the efficacy measure of mean lactate dehydrogenase (LDH) levels across the two formulations. The new proposed formulation requires an infusion time of 0.4 to 1.3 hours (25 to 75 minutes) depending on body weight, reducing the infusion time by approximately 60 percent compared with the currently available 10 mg/mL IV formulation, which ranges from 1.3 to 3.3 hours (77 to 194 minutes) depending on body weight.

ULTOMIRIS 100 mg/mL was approved by the U.S. Food and Drug Administration (FDA) in October 2020, and a regulatory filing is under review in Japan.

Alexion continues to innovate with ULTOMIRIS, with the goal of improving the patient experience. We plan to submit regulatory filings in the U.S. and EU in the third quarter of 2021 for an ULTOMIRIS subcutaneous formulation and device combination for PNH and aHUS that can be self-administered at home, pending completion of the ongoing Phase 3 study and collection of 12-month safety data. In addition, the collective ULTOMIRIS clinical development programs present an opportunity to expand treatment for rare diseases across hematology, nephrology, neurology, and for the treatment of severe COVID-19, with seven Phase 3 programs that are ongoing or have planned clinical trial initiations in 2020.

About Paroxysmal Nocturnal Hemoglobinuria (PNH)PNH is a serious ultra-rare blood disorder with devastating consequences. It is characterized by the destruction of red blood cells, which is also referred to as hemolysis. PNH occurs when the complement systema part of the bodys immune systemover-responds, leading the body to attack its own red blood cells. PNH often goes unrecognized, with delays in diagnosis from one to more than five years.Patients with PNH may experience a range of symptoms, such as fatigue, difficulty swallowing, shortness of breath, abdominal pain, erectile dysfunction, dark-colored urine and anemia. The most devastating consequence of chronic hemolysis is the formation of blood clots, which can occur in blood vessels throughout the body, damage vital organs, and potentially lead to premature death.PNH can strike men and women of all races, backgrounds and ages without warning, with an average age of onset in the early 30s.

About Atypical Hemolytic Uremic Syndrome (aHUS)aHUS is an ultra-rare disease that can cause progressive injury to vital organs, primarily the kidneys, via damage to the walls of blood vessels and blood clots. aHUS occurs when the complement systema part of the bodys immune systemover-responds, leading the body to attack its own healthy cells. aHUS can cause sudden organ failure or a slow loss of function over timepotentially resulting in the need for a transplant, and in some cases, death. aHUS affects both adults and children, and many patients present in critical condition, often requiring supportive care, including dialysis, in an intensive care unit. The prognosis of aHUS can be poor in many cases, so a timely and accurate diagnosisin addition to treatmentis critical to improving patient outcomes. Available tests can help distinguish aHUS from other hemolytic diseases with similar symptoms.

About ULTOMIRISULTOMIRIS (ravulizumab) is the first and only long-acting C5 complement inhibitor. The medication works by inhibiting the C5 protein in the terminal complement cascade, a part of the bodys immune system. When activated in an uncontrolled manner, the complement cascade over-responds, leading the body to attack its own healthy cells. ULTOMIRIS is administered intravenously every eight weeks or, for pediatric patients less than 20 kg, every four weeks, following a loading dose. ULTOMIRIS is approved in the United States (U.S.), European Union (EU) and Japan as a treatment for adults with paroxysmal nocturnal hemoglobinuria (PNH). It is also approved in the U.S. and Japan for atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) in adult and pediatric (one month of age and older) patients, as well as in the EU for the treatment of adults and children with a body weight of at least 10 kg with aHUS. In the U.S., ULTOMIRIS is available in two formulations with the same mechanism of action and consistent safety and efficacy. The ULTOMIRIS 100 mg/mL formulation reduces average annual infusion time for patients with aHUS and PNH by approximately 60 percent (to approximately 45 minutes for adults in the average weight cohort) compared to the ULTOMIRIS 10 mg/mL formulation. To learn more about the regulatory status of ULTOMIRIS in the countries that we serve, please visit http://www.alexion.com.

About AlexionAlexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on hematology, nephrology, neurology, metabolic disorders, cardiology, ophthalmology and acute care. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. This press release and further information about Alexion can be found at: http://www.alexion.com.

[ALXN-P]

Forward-Looking StatementThis press release contains forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Alexion, including statements related to: the safety, efficacy and benefits of the 100 mg/mL ULTOMIRIS formulation as a treatment for PNH and aHUS; that ULTOMIRIS 100 mg/mL formulation reduces infusion time as compared to the 10 mg/mL formulation of ULTOMIRIS by approximately 60% with comparable safety and efficacy; with ULTOMIRIS 100 mg/mL, most patients will spend six hours or less a year receiving treatment; this new formulation is another step forward in reducing the overall treatment burden; patients will experience comparable safety and efficacy to the original formulation while spending significantly less time per year receiving treatment; that shorter infusion times will make a meaningful difference in patient lives; that this new formulation demonstrates Alexions continued commitment to innovating for patients and their families; that 100 mg/mL ULTOMIRIS lessens the overall burden on healthcare systems and practitioners with reduced infusion times, and on patients, who will only spend six hours or less a year receiving their treatment; Alexion plans to submit regulatory filings in the U.S. and EU in the third quarter of 2021 for an ULTOMIRIS subcutaneous formulation and device combination for PNH and aHUS that can be self-administered at home; the collective ULTOMIRIS clinical development programs present an opportunity to expand treatment for rare diseases across hematology, nephrology, neurology, and for the treatment of severe COVID-19; and that Alexion has seven Phase 3 programs that are ongoing or have planned clinical trial initiations in 2020. Forward-looking statements are subject to factors that may cause Alexion's results and plans to differ materially from those expected by these forward looking statements, including for example: the anticipated safety profile and the benefits of the ULTOMIRIS 100 mg/ml formulation may not be realized (and the results of the clinical trials may not be indicative of future results); results of clinical trials may not be sufficient to satisfy regulatory authorities; results in clinical trials may not be indicative of results from later stage or larger clinical trials (or in broader patient populations); the possibility that results of clinical trials are not predictive of safety and efficacy and potency of our products (or we fail to adequately operate or manage our clinical trials) which could cause us to discontinue sales of the product (or halt trials, delay or prevent us from making regulatory approval filings or result in denial of approval of our product candidates); the severity of the impact of the COVID-19 pandemic on Alexions business, including on commercial and clinical development programs; unexpected delays in clinical trials; unexpected concerns regarding products and product candidates that may arise from additional data or analysis obtained during clinical trials or obtained once used by patients following product approval; future product improvements may not be realized due to expense or feasibility or other factors; delays (expected or unexpected) in the time it takes regulatory agencies to review and make determinations on applications for the marketing approval of our products; inability to timely submit (or failure to submit) future applications for regulatory approval for our products and product candidates; inability to timely initiate (or failure to initiate) and complete future clinical trials due to safety issues, IRB decisions, CMC-related issues, expense or unfavorable results from earlier trials (among other reasons); our dependence on sales from our principal product (SOLIRIS); future competition from biosimilars and novel products; decisions of regulatory authorities regarding the adequacy of our research, marketing approval or material limitations on the marketing of our products; delays or failure of product candidates to obtain regulatory approval; delays or the inability to launch product candidates due to regulatory restrictions, anticipated expense or other matters; interruptions or failures in the manufacture and supply of our products and our product candidates; failure to satisfactorily address matters raised by regulatory agencies regarding our products and product candidates; uncertainty of long-term success in developing, licensing or acquiring other product candidates or additional indications for existing products; inability to complete acquisitions or grow the product pipeline through acquisitions (including due to failure to obtain antitrust approvals); the possibility that current rates of adoption of our products are not sustained; the adequacy of our pharmacovigilance and drug safety reporting processes; failure to protect and enforce our data, intellectual property and proprietary rights and the risks and uncertainties relating to intellectual property claims, lawsuits and challenges against us (including intellectual property lawsuits relating to ULTOMIRIS brought by third parties); the risk that third party payors (including governmental agencies) will not reimburse or continue to reimburse for the use of our products at acceptable rates or at all; failure to realize the benefits and potential of investments, collaborations, licenses and acquisitions; the possibility that expected tax benefits will not be realized or that tax liabilities exceed current expectations; potential declines in sovereign credit ratings or sovereign defaults in countries where we sell our products; delay of collection or reduction in reimbursement due to adverse economic conditions or changes in government and private insurer regulations and approaches to reimbursement; adverse impacts on our supply chain, clinical trials, manufacturing operations, financial results, liquidity, hospitals, pharmacies and health care systems from natural disasters and global pandemics, including COVID-19; uncertainties surrounding legal proceedings, company investigations and government investigations; the risk that estimates regarding the number of patients with PNH, aHUS, gMG, NMOSD, HPP and LAL-D and other indications we are pursuing (as well as patients requiring a Factor Xa inhibitor reversal agent) are inaccurate; the risks of changing foreign exchange rates; risks relating to the potential effects of the Company's restructuring; risks related to the acquisitions of Portola Pharmaceuticals, Achillion and other companies and co-development efforts; and a variety of other risks set forth from time to time in Alexion's filings with the SEC, including but not limited to the risks discussed in Alexion's Quarterly Report on Form 10-Q for the period ended September 30, 2020 and in our other filings with the SEC. Alexion disclaims any obligation to update any of these forward-looking statements to reflect events or circumstances after the date hereof, except when a duty arises under law.

References

Short ULTOMIRIS SmPC June 2020

ULTOMIRIS (ravulizumab) Prescribing Information

Please refer to the SmPC for further information before prescribing.

ULTOMIRIS 300 mg concentrate for solution for infusion

Qualitative and quantitative composition: One vial of 30 mL contains 30 0mg of ravulizumab, produced in Chinese hamster ovary (CHO) cell culture by recombinant DNA technology. After dilution, the final concentration of the solution to be infused is 5 mg/mL. Excipient(s) with known effect: Sodium (5 mmol per vial). Clear to translucent, slight whitish colour, pH 7.0 solution.

Therapeutic indication: Treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) in patients with haemolysis with clinical symptom(s) indicative of high disease activity and in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. Treatment of patients with a body weight of 10 kg or above with atypical haemolytic uremic syndrome (aHUS) who are complement inhibitor treatment-nave or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Posology and method of administration. Posology: The recommended dosing regimen consists of a loading dose followed by maintenance dosing, administered by intravenous infusion. The doses to be administered are based on the patients body weight. For adult patients ( 18 years of age), maintenance doses should be administered at a once every 8 week interval, starting 2 weeks after loading dose administration. Dosing schedule is allowed to occasionally vary by 7 days of the scheduled infusion day (except for the first maintenance dose of ravulizumab) but the subsequent dose should be administered according to the original schedule. For patients switching from eculizumab to ravulizumab, the loading dose of ravulizumab should be administered 2 weeks after the last eculizumab infusion, and then maintenance doses are administered once every 8 weeks, starting 2 weeks after loading dose administration. Ravulizumab has not been studied in patients with PNH who weigh less than 40 kg. There is no experience of concomitant PE/PI (plasmapheresis or plasma exchange, or fresh frozen plasma infusion) use with ravulizumab. Administration of PE/PI may reduce ravulizumab serum levels. In aHUS, ravulizumab treatment to resolve TMA manifestations should be for a minimum duration of 6 months, beyond which length of treatment needs to be considered for each patient individually. Patients who are at higher risk for TMA recurrence, as determined by the treating healthcare provider (or clinically indicated), may require chronic therapy. Special Populations: Paediatric patients with aHUS with body weight 40 kg are treated in accordance with the adult dosing recommendations. The weight-based doses and dosing intervals for paediatric patients 10 kg to 20 kg is once every 4 week interval, for paediatric patients 20 kg to 40 kg once every 8 weeks, starting 2 weeks after loading dose administration. Data to support safety and efficacy of ravulizumab for patients with body weight below 10 kg are limited. No recommendation on a posology can be made for patients below 10 kg body weight (please refer to the SmPC for currently available data). The safety and efficacy of ravulizumab in children with PNH aged 0 to < 18 years have not been established. No data are available. Method of administration: For intravenous infusion only. ULTOMIRIS must be diluted to a final concentration of 5 mg/mL. This medicinal product must be administered through a 0.2 m filter and should not be administered as an intravenous push or bolus injection. ULTOMIRIS must be diluted prior to administration by intravenous infusion over a minimal period of 1.7 to 2.4 hours depending of body weight (please refer to the SmPC).

Contraindications: Hypersensitivity to the active substance or to any of the excipients; in patients with unresolved Neisseria meningitidis infection at treatment initiation; in patients who are not currently vaccinated against Neisseria meningitidis unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination. Special warnings and precautions for use. Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Serious meningococcal infection: Due to its mechanism of action, the use of ravulizumab increases the patient's susceptibility to meningococcal infection/sepsis (Neisseria meningitidis). Meningococcal disease due to any serogroup may occur. To reduce this risk of infection, all patients must be vaccinated against meningococcal infections at least two weeks prior to initiating ravulizumab unless the risk of delaying ravulizumab therapy outweighs the risk of developing a meningococcal infection. Patients who initiate ravulizumab treatment less than 2 weeks after receiving a meningococcal vaccine, must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination. Vaccines against serogroups A, C, Y, W135 and B where available, are recommended in preventing the commonly pathogenic meningococcal serogroups. Patients must be vaccinated or revaccinated according to current national guidelines for vaccination use. If the patient is being switched from eculizumab treatment, physicians should verify that meningococcal vaccination is current according to national guidelines for vaccination use. Vaccination may not be sufficient to prevent meningococcal infection. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Cases of serious meningococcal infections/sepsis have been reported in patients treated with ravulizumab. Cases of serious or fatal meningococcal infections/sepsis have been reported in patients treated with other terminal complement inhibitors. All patients should be monitored for early signs of meningococcal infection and sepsis, evaluated immediately if infection is suspected, and treated with appropriate antibiotics. Patients should be informed of these signs and symptoms and steps should be taken to seek medical care immediately. Physicians should provide patients with a patient information brochure and a patient safety card. Immunization: Prior to initiating ravulizumab therapy, it is recommended that PNH and aHUS patients initiate immunizations according to current immunization guidelines. Vaccination may further activate complement. As a result, patients with complement-mediated diseases, including PNH and aHUS, may experience increased signs and symptoms of their underlying disease, such as haemolysis. Therefore, patients should be closely monitored for disease symptoms after recommended vaccination. Patients below the age of 18 years old must be vaccinated against Haemophilus influenzae and pneumococcal infections, and strictly need to adhere to the national vaccination recommendations for each age group. Other systemic infections: Ravulizumab therapy should be administered with caution to patients with active systemic infections. Ravulizumab blocks terminal complement activation; therefore, patients may have increased susceptibility to infections caused by Neisseria species and encapsulated bacteria. Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported. Patients should be provided with information from the Package Leaflet to increase their awareness of potential serious infections and their signs and symptoms. Physicians should advise patients about gonorrhea prevention. Infusion reactions: Administration of ravulizumab may result in infusion reactions. In clinical trials, with PNH and aHUS [(4 out of 296 in patients with PNH) and (4 of 89 patients with aHUS)] patients experienced infusion reactions which were mild in severity and transient [e.g., lower back pain, drop in blood pressure, elevation in blood pressure, limb discomfort, drug hypersensitivity (allergic reaction), and dysgeusia(bad taste)]. In case of infusion reaction, infusion of ravulizumab should be interrupted and appropriate supportive measures should be instituted if signs of cardiovascular instability or respiratory compromise occur.

Treatment discontinuation for PNH: If patients with PNH discontinue treatment with ravulizumab, they should be closely monitored for signs and symptoms of serious intravascular haemolysis, identified by elevated LDH (lactate dehydrogenase) levels along with sudden decrease in PNH clone size or haemoglobin, or re-appearance of symptoms such as fatigue, haemoglobinuria, abdominal pain, shortness of breath (dyspnoea), major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction. Any patient who discontinues ravulizumab should be monitored for at least 16 weeks to detect haemolysis and other reactions. If signs and symptoms of haemolysis occur after discontinuation, including elevated LDH, consider restarting treatment with ravulizumab. Treatment discontinuation for aHUS: There are no specific data on ravulizumab discontinuation. In a long-term prospective observational study, discontinuation of complement C5 inhibitor treatment (eculizumab) resulted in a 13.5-fold higher rate of TMA recurrence and showed a trend toward reduced renal function compared to patients who continued treatment. If patients must discontinue treatment with ravulizumab, they should be monitored closely for signs and symptoms of TMA on an on-going basis. However, monitoring may be insufficient to predict or prevent severe TMA complications. TMA complications post-discontinuation can be identified if any of the following is observed: (i) At least two of the following laboratory results observed concurrently: a decrease in platelet count of 25% or more as compared to either baseline or to peak platelet count during ravulizumab treatment; an increase in serum creatinine of 25% or more as compared to baseline or to nadir during ravulizumab treatment; or, an increase in serum LDH of 25% or more as compared to baseline or to nadir during ravulizumab treatment (results should be confirmed by a second measurement), or (ii) any one of the following symptoms of TMA: a change in mental status or seizures or other extra-renal TMA manifestations including cardiovascular abnormalities, pericarditis, gastrointestinal symptoms/diarrhoea; or thrombosis. If TMA complications occur after ravulizumab discontinuation, consider reinitiation of ravulizumab treatment beginning with the loading dose and maintenance dose. This medicinal product when diluted with sodium chloride 9 mg/mL (0.9 %) solution for injection contains 2.65 g sodium per 720 mL at the maximal dose, equivalent to 133 % of the WHO recommended maximum daily intake of 2 g sodium for an adult. Interaction with other medicinal products and other forms of interaction: No interaction studies have been performed. Chronic intravenous human immunoglobulin (IVIg) treatment may interfere with the endosomal neonatal Fc receptor (FcRn) recycling mechanism of monoclonal antibodies such as ravulizumab and thereby decrease serum ravulizumab concentrations. Fertility, pregnancy and lactation. Women of childbearing potential: Women of childbearing potential should use effective contraception methods during treatment and up to 8 months after treatment. Pregnancy: There are no clinical data from the use of ravulizumab in pregnant women. Nonclinical reproductive toxicology studies were not conducted with ravulizumab. Reproductive toxicology studies were conducted in mice using the murine surrogate molecule BB5.1, which assessed effect of C5 blockade on the reproductive system. No specific test-article related reproductive toxicities were identified in these studies. Human IgG are known to cross the human placental barrier, and thus ravulizumab may potentially cause terminal complement inhibition in the foetal circulation. Animal studies are insufficient with respect to reproductive toxicity. In pregnant women the use of ravulizumab may be considered following an assessment of the risks and benefits. Breast-feeding: It is unknown whether ravulizumab is excreted into human milk. Nonclinical reproductive toxicology studies conducted in mice with the murine surrogate molecule BB5.1 identified no adverse effect to pups resulting from consuming milk from treated dams. A risk to infants cannot be excluded. Since many medicinal products and immunoglobulins are secreted into human milk, and because of the potential for serious adverse reactions in nursing infants, breast-feeding should be discontinued during treatment with ravulizumab and up to 8 months after treatment. Fertility: No specific non-clinical study on fertility has been conducted with ravulizumab. Nonclinical reproductive toxicology studies conducted in mice with a murine surrogate molecule (BB5.1) identified no adverse effect on fertility of the treated females or males.

Undesirable effects. Summary of the safety profile: The most common adverse drug reactions (very common frequency) are diarrhea, nausea, vomiting, nasopharyngitis and headache. The most serious adverse reactions in patients in clinical trials are meningococcal infection and meningococcal sepsis. Tabulated list of adverse reactions: Very common adverse reactions observed from PNH and aHUS clinical trials (1/10): Upper respiratory tract infection, Nasopharyngitis, Headache, Diarrhoea, Nausea, Pyrexia, Fatigue. Common adverse reactions (1/100 to <1/10): Dizziness, Abdominal pain, Vomiting, Dyspepsia, Rash, Pruritus, Arthralgia, Back pain, Myalgia, Muscle spasms, Influenza like illness, Asthenia. Uncommon adverse reactions (1/1,000 to <1/100): Meningococcal infection, Chills. In paediatric patients with evidence of aHUS (aged 10 months to less than 18 years) included in the clinical study, the safety profile of ravulizumab appeared similar to that observed in adult patients with evidence of aHUS. The safety profiles in the different paediatric subsets of age appear similar. The safety data for patient below 2 years of age is limited to four patients. The most common adverse reaction reported in paediatric patients was pyrexia. The safety of ravulizumab in children with PNH aged 0 to < 18 years have not been established. No data are available.

Storage: 2C 8C. Marketing Authorization Holder: Alexion Europe SAS, 1-15, 103-105 rue Anatole France, 92300 Levallois-Perret, FRANCE.

Marketing Authorisation Number: EU/1/19/1371/001. Date of First Authorisation: {02 July 2019}. Date of revision: {25 June 2020}. Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.

Excerpt from:
Alexion Receives Marketing Authorization from European Commission for New Formulation of ULTOMIRIS (ravulizumab) with Significantly Reduced Infusion...

After a week of being too close to call, Californias Proposition 14 has passed, allowing the state to issue $5.5 billion in bonds for stem cell research.

The measure flew under the radar early in the election season, with almost no opposition and $15 million spent by proponents. But Californians were split on the measure, with just 51% of residents voting yes as of Nov. 12 when the race was called.

Proposition 14 was brought forward by real estate developer Robert Klein, who formerly served as board chairman of the California Institute for Regenerative Medicine (CIRM). The agency was created by another ballot proposition in 2004, and remains one of the only state-funded stem cell research agencies in the United States.

John Matsusaka, a University of Southern California economist with a focus on the ballot process, says this measure put a tough decision on voters.

Theres many useful things you might want to do research on, is this the one you want to put so much money into, he asked. This was an interest group who said they wanted to carve out one thing for themselves which raises some questions.

CIRM was envisioned as a mecca of biological discovery that would make California a leader in curing diseases such as Alzheimers, cancer and diabetes. Proponents say a new injection of state funding will help them continue this important work.

But the agency has faced criticism over the years from those who feel the promised research hasnt materialized, and that conflicts of interest have compromised the institutes integrity.

David Jensen, author of a book about the Institute called Californias Great Stem Cell Experiment, says even with the passage of Proposition 14, doubts about the agencys future remain.

[In 2004], people were led to believe that stem cell therapies and cures were right around the corner. That did not turn out to be the case, he said. It's very important to finance stem cell research. The question is, should the state do that?

Controversial Beginnings

California voters were first asked to weigh in on stem cell funding in 2004. At the time, George W. Bush was in the White House and had banned federally funded embryonic stem cell research.

That meant California scientists investigating HIV/AIDS treatments, Parkinson's cures and more were fighting over a trickling well of funding. So they took to the ballot with Proposition 71, which passed with 59% of the votes. That allowed the state to issue $3 billion in bonds for the creation of the California Institute for Regenerative Medicine.

Because of the timing, it was a shot in the arm to the field, said Zach Hall, who served as the first president of CIRM.

Proposition 14 opponents argue that because former President Barack Obama lifted restrictions on embryonic stem cell research, California scientists can now lean on federal grants and private industry funding to carry their work through.

The NIH could support most of the work that CIRM has funded in the past 10 years, and so the rationale for having a new proposition and increasing the amount of money is unclear, Hall said. You could say just as well why dont we have a state agency to fund CRISPR research?

But supporters argue that federal grants are competitive, and there isnt enough money in the national cache or in private industry to backfill what CIRM provides for researchers across the state.

Robert Klein, former chairman of the Institutes board and leader of the campaign supporting Proposition 14, said that without new bond funding, the Institutes existing research projects would be out of money once they reach the ends of their current grant cycles.

Those trials will not have any funding available to take them forward, he said. And we have a pent-up demand waiting for these new funds from Prop 14 for dozens of new trials for new therapies.

Last summer CIRM told researchers it would stop accepting new grant applications, with the exception of $5 million in emergency funding it set aside for COVID-19 research.

Where Did The First $3 Billion Go?

Supporters of Proposition 14 say the work that CIRM has done over the years has brought California to the forefront in stem cell research, and laid the groundwork for cures to hundreds of diseases.

The agency has distributed hundreds of research grants to public and private universities, medical research institutions and for-profit companies.

Nearly 40%of that money has gone into basic research that helps scientists understand stem cells and how they might be used in medicine, according to a San Francisco Chronicle analysis of CIRM spending. The list of conditions researchers have focused on is long, and includes heart disease, Huntingtons, leukemia, Alzheimers and glioblastoma, to name just a few.

CIRM put 16% of the money into building infrastructure, including about a dozen stem cell research centers, according to the analysis. Another $388 million went toward taking research out of the lab and applying it to humans.

Of the 90 clinical trials the Institute has funded, two drugs have earned FDA approval for fatal forms of blood cancer, according to the campaign supporting the proposition.

The campaign reports CIRM-funded researchers have published 2,900 medical discoveries.

From Sacramento to San Francisco to LA to San Diego, these world eminent scientist leaders in this field came together and said we have to have this funding to go forward, Klein said. We cant attract and hold the best scientists in the world unless we can show them that the therapies they work on are going to actually be able to get to patients.

Supporters also argue that Proposition 71 was an economic boon for the Golden State. A 2019 study from the University of Southern California (commissioned by CIRM) estimates that the Institutes impact on Californias economy is $10.7 billion in gross output, $641.3 million in tax revenue and nearly 56,000 jobs created.

But Matsusaka, a USC economics professor who was not affiliated with that study, says hes doubtful that the $5.5 billion that Proposition 14 will inject into stem cell research will be the job-generator California needs now.

This is money thats channeling into research, into scientists, into highly skilled white collar workers who are very fully employed already, he said. If you were pouring money into restaurant workers or something like that I think there could be a stimulating effect because thats where theres a big pool of people who are unemployed right now. Its hard for me to see how pouring money into this could have a stimulating effect.

And he says pulling money out of other sectors to support this work could do harm to the states economy more broadly.

Conflicts of Interest

At several points during its 16-year history, CIRM has been criticized for conflicts of interest between its board and the researchers it supports.

An analysis from the California Stem Cell Report, which has been tracking the agency since its inception, found that Stanford University, UCLA and UC San Diego are the top recipients of CIRM funding, and they all have representatives on the CIRM board.

Far too many board members represent organizations that receive CIRM funding or benefit from that funding, wrote the National Academy of Medicine in a 2012 study of the agency. These competing personal and professional interests compromise the perceived independence of the ICOC (the CIRM governing board), introduce potential bias into the boards decision making, and threaten to undermine confidence in the board.

In 2014, a former CIRM president left his job and almost immediately took a high-paying position at an agency that receives research funding from the Institute. David Jensen with California Stem Cell Report has tracked several other conflict of interest issues within the organization.

He says Proposition 14 changes some legal definitions and increases the number of people on the board from 29 to 35, but does not do anything to ameliorate those problems.

If youve got the dean of the medical school at UC Davis sitting on that board, voting on programs that might benefit his or her institution, legally or not thats still a conflict of interest, he said.

The agency has historically argued that the relationships between its board members and the scientists it supports are in line with its established conflict of interest policies.

After Proposition 14 was declared successful, the campaign supporting it called the measure one of the most important investments our state can make.

Over the past decade, California has made incredibly thoughtful and impactful investments in developing stem cell therapies and cures for diseases and conditions like diabetes, cancer, blindness, Parkinsons, paralysis and many more, wrote Robert and Danielle Klein, with the Californians for Stem Cell Research, Treatments and Cures campaign, in a statement. Now we know this progress and work to mitigate human suffering, restore health and improve the human condition will continue.

The measure will ultimately result in California taking on $7.8 billion dollars in debt, including interest.

See more here:
California's Stem Cell Agency Will Get A Funding Boost From Prop 14. Here's A Look At Its History. - Capital Public Radio News

The global stem cell banking market was valued at $1,986 million in 2016, and is estimated to reach $6,956 million by 2023, registering a CAGR of 19.5% from 2017 to 2023. Stem cell banking is a process where the stem cell care isolated from different sources such as umbilical cord and bone marrow that is stored and preserved for future use. These cells can be cryo-frozen and stored for decades. Private and public banks are different types of banks available to store stem cells.

Top Companies Covered in this Report: Cord Blood Registry, ViaCord, Cryo-Cell, China Cord Blood Corporation, Cryo-Save, New York Cord Blood Program, CordVida, Americord, CryoHoldco, Vita34

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Increase in R&D activities in regards with applications of stem cells and increase in prevalence of fatal chronic diseases majorly drive the growth of the global stem cell banking market. Moreover, the large number of births occurring globally and growth in GDP & disposable income help increase the number of stem cell units stored, which would help fuel the market growth. However, legal and ethical issues related to stem cell collections and high processing & storage cost are projected to hamper the market growth. The initiative taken by organizations and companies to spread awareness in regards with the benefits of stem cells and untapped market in the developing regions help to open new avenues for the growth of stem cell banking market in the near future.

The global stem cell banking market is segmented based on cell type, bank type, service type, utilization, and region. Based on cell type, the market is classified into umbilical cord stem cells, adult stem cells, and embryonic stem cells. Depending on bank type, it is bifurcated into public and private. By service type, it is categorized into collection & transportation, processing, analysis, and storage. By utilization, it is classified into used and unused. Based on region, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA.

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Table Of Content

CHAPTER 1: INTRODUCTION

CHAPTER 2: EXECUTIVE SUMMARY

CHAPTER 3: MARKET OVERVIEW

CHAPTER 4: STEM CELL BANKING MARKET, BY CELL TYPE

CHAPTER 5: STEM CELL BANKING MARKET, BY BANK TYPE

CHAPTER 6: STEM CELL BANKING MARKET, BY SERVICE TYPE

CHAPTER 7: STEM CELL BANKING MARKET, BY UTILIZATION

CHAPTER 8: STEM CELL BANKING MARKET, BY REGION

CHAPTER 9: COMPANY PROFILES

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Stem Cell Banking Market is Projected to Reach $6,956 million by 2023 | Leading key players are Cord Blood Registry, ViaCord, Cryo-Cell, China Cord...

Both inside and outside state prisons, the numbers for COVID-19 infection continue to rise across Wisconsin. Over 312,000 people have tested positive for the virus statewide and 2,637 Badger residents have died after contracting the virus. Over 6,977 of those positive tests, and 10 of those deaths, have occurred among people incarcerated within Department of Corrections (DOC) facilities. Some 2,063 of those cases are listed as active positives, the largest single day spike in Badger State prisons to date.

Its bad, man, 36-year-old Bradley Sewell, whos incarcerated at the Waupun Correctional Institution (WCI), told Wisconsin Examiner in a DOC-monitored phone call. Since around March, recreational activities and other programs have been restricted in prisons to help prevent the virus spread. Particularly since the numbers began to spike within facilities like WCI, incarcerated people say they feel they have little else to do other than sit around and wait for their turn to receive a positive test.

Sewell got a positive test result just days before reaching out to Wisconsin Examiner. I already knew something was wrong, though, said Sewell, because I was feeling very, very ill. Very, very ill, the usual I couldnt taste, couldnt smell. Sweating profusely, very, very, very cold and hot at the same time. Body aches, muscle aches, all of that. And the treatment I received was a bottle of aspirin. A small bottle of 500mg aspirinand it doesnt help. It dont help at all.

As more people become infected, Sewell has also noticed that people who have tested positive sometimes remain in their cells alongside people who hadnt yet tested positive. In the very beginning they were trying to do quarantine, said Sewell. In the very beginning, if you were exhibiting symptoms, you were taken to whats called the north cell hall. The north cell hall is typically the cell hall for receiving, for guys whore first coming into the prison. So if you were exhibiting symptoms, or you tested positive, they would take you over there. But since theres so many cases in the prison now, theyre just leaving you in your cell. Some guys have their own cell but most guys, theres two to a cell.

A DOC spokesperson informed Wisconsin Examiner that as of Friday, roughly 60 people were in isolation and quarantined at WCI. The National Guard was at Waupun for more testing of staff and persons in our care last week, the spokesperson, John Beard said. The rate of infection from COVID-19 began spiking at WCI in late October.

From Aug. 1-Oct. 1, the number of positive tests among incarcerated people at WCI remained at 228. On Oct.7 however, according to the DOCs online COVID dashboard, the number rose slightly to 232. By Oct. 15 the number rose to 257, with 29 people who were actively exhibiting symptoms. By Oct. 21, 289 people had tested positive at WCI, and then 411 on Oct. 23. Some 685 people had tested positive at WCI by Nov. 13, with 59 active cases at the facility, and 1 person who tested positive and was released. Today, Nov. 17, the number of positive cases hovers at around 54 people.

Yellow line: Total number of tests. Red line: negative tests, Blue line: positive tests, Green line: active positives (Chart created by Isiah Holmes)

At the same time, WCIs overall incarcerated population remained stubbornly high. While designed for a capacity of 882 people, WCI housed 1,185 incarcerated people in August, according to DOC population updates. As October rolled around, the number dropped slightly to 1,179 people. Between October and November, 10 more people were released from the facility, bringing the total to 25 people released over the last three months.

In May, the state of Wisconsin released a report which explored the need and possibility of early release due to the pandemic. The report found that the incarcerated population is especially vulnerable to COVID-19, due to the high prevalence of severe pre-existing conditions among prison populations. The report noted that, confirmed cases of COVID-19 among staff and inmates at several facilities have raised the question of whether the state should release certain high-risk individuals, either pre-trial or post-sentencing. Several other states including California and Ohio have taken steps in this direction.

Lowering the prison population has been a main goal pushed by incarceration and prison reform activists since the pandemic began. Going into next years budget cycle, the Evers administration has stated it will explore numerous budget reform issues for the DOC. Among these is the problem of re-incarceration through probation and parole revocation as well as increasing programming for incarcerated people to ensure that they dont return to prison. This late into the game, however, some feel its too little too late.

Fontaine Baker, who is also incarcerated in WCI, worries that the virus has outpaced the efforts of officials to grant early releases. You bound to catch it, Baker told Wisconsin Examiner. I think I got it now because I got the loss of smell. The nurse came over this morning, I got a temperature of 103. I dont feel like a headache but I feel body aches, body pains. When he informed the nurse, Baker says he was told to drink more water and take the Tylenol provided by staff.

The worsening situation in the prison has begun to demoralize the incarcerated population. Baker was originally transferred to WCI to take a program through which he could obtain a bachelors degree. It was a trade-off for the 45-year-old, who had to transfer from a medium-security facility to WCI, which is maximum security, in order to join the program. I graduate next year, says Baker, or Im supposed to graduate next year but I might not make it, the way its looking.

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After a round of COVID tests in late October, Baker and Sewell say that many were shocked to learn that several people who just tested positive had recently worked in the prisons kitchens. Come to find out that some of the people who got tested on [Oct 21] went to work on [Oct.21-23]. They had COVID, so they were up in the kitchen cooking and passing out our food, says Baker. He and Sewell both place much of the responsibility for spreading the virus on staff members. Thats probably the biggest issue, says Sewell. How are they dealing with staff that are coming into the prison?

According to a National Guard update on COVID testing, a team went to WCI from Oct.20-23 and gathered over 1,300 samples. This cell hall right here received their test on Oct. 21, thats when we received our test by the National Guard, says Sewell. So guys were working in the kitchen that Wednesday, Thursday, Friday and then Sunday come and there were guys who tested positive that were working in the kitchen.

Although staff attempted to find volunteers to replace the infected kitchen staff, Sewell feels it was far too late. The thing is the virus is running so rampant through the prison that there really isnt nobody, says Sewell. There arent enough people who dont have the virus to work.

When the pandemic first began, Baker recalls that some staff did not consistently wear their masks. Oftentimes we have noticed officers who are not wearing masks, says Sewell. So if you have a number of officers who are not wearing masks who may be infected they may be asymptomatic but theyre infected then they could potentially spread the virus to us.

Baker says he has seen a similar attitude expressed by some staff. You have certain guards around here not wearing their masks at all. Its a recurring complaint reported by incarcerated people in Wisconsin over the past several months. The justifications they hear from staff stem from the lack of a legal mandate with clear consequences for not wearing a mask.

Since the COVID first hit here, I was one of the ones always calling them out for not wearing their masks, said Baker. And one of the first things that they told me way back when a couple months ago was, Oh were not mandated to wear our masks. But Im saying the news is telling us they got to wear them in supermarkets and stores. So yall are telling us youre not mandated to wear it, but yall are the first line of defense for us. Because yall are the only way it can come up in here.

According to the DOC COVID dashboard, 117 staff members at WCI have tested positive for the virus. While staff temperatures are checked before their shift begins, other information is self-reported, according to the page. Across the entire DOC network of facilities, some 1,470 staff members have tested positive for the virus since testing began months ago.

Sitting in their cells, some alone and others with a cellmate, the people incarcerated in WCI hear rumors of people whove gotten particularly sick, or hadnt been heard from again after their last infirmary or hospital visit. The guards every now and again, theyll say stuff, says Baker. So they took somebody up out of here and he supposedly passed away. When I had my people call up here and talk to them they said, Nobody died in Waupun. Well we know aint nobody died in Waupun because you took them up out of here.

Sewell has heard similar reports. Were trying to figure out if this brother died or not, he told Wisconsin Examiner. He was just taken to the hospital and were not sure if he survived or not. There were some rumors going around that he died, but were not sure. We know that they took him to the hospital, they had to rush him to the hospital. He was older, he was in his late 50s, I believe.

Beard was unable to confirm any facility-specific information regarding COVID-related deaths of incarcerated people. We are reporting a total number of COVID-19 related deaths since the beginning of the pandemic on our dashboard, he said. As with the rest of the information on our dashboard, it is offered in an effort to be transparent about the current state of the virus in DOC institutions. We are not reporting identifying information related to those COVID-19 related deaths, in an effort to protect the identity and personal health information of those in our care.

Moving forward, Baker and Sewell have little else but time on their hands. What are we supposed to do? asks Baker. If were in the Department of Corrections, and theyre supposed to be the ones protecting us, taking care of us, theyre supposed to be examples for us in these time of correction, if youre not following the rules how do you expect us to follow any rules? If youre not doing what youre supposed to do, how do you expect somebody to actually have faith in your system to sit up here and say theyre going to help you be a better person in society once you leave here?

Neither Baker nor Sewell seemed afraid of retaliation for speaking out. We not concerned about that, Sewell told Wisconsin Examiner. If it happens, then we deal with it. The fact that it happens is not going to stop me from talking to you. But it could be seen, because this call is being monitored or recorded.

Sewell has been locked up for nearly 17 years, and Baker for two decades. For them, there isnt much the system can do to move them. Right now its killing hope, said Baker. So I think the best thing to do is get the word out, man. Let them see us, let them hear us. Aint nothing like hearing it from the horses mouth. We in the midst of it. We right here.

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Locked up during the Waupun COVID surge - Wisconsin Examiner

The Alexander Grass Humanities Institute (AGHI), in conjunction with Great Talk, Inc., hosted a panel of scientists to speak about the ethical considerations and implications of stem cell research on Oct. 21.

The event was moderated by Director of AGHI William Egginton. The four panelists included two experts in genomics research, a journalist who specializes in the role of technology in biomedical research and an expert in medical law.

Dr. Anthony Wynshaw-Boris, chair of the Department of Genetics and Genome Sciences at Case Western Reserve University School of Medicine, discussed how cell lines were cultivated as tools in the past for scientists to use to grow cell cultures to study diseases or develop vaccines. However, there wasnt as much debate about the development of these tools in the past as there is now.

These are scientific tools that we use. The political and social aspects... are arising today because of our polarization, Wynshaw-Boris said.

The panel had an in-depth conversation regarding the ethics of the use of scientific tools such as stem cell lines derived from fetal tissue, embryonic cells, abortion-derived cell lines and cells acquired without consent.

Dr. Eric Green, director of the National Human Genome Research Institute at the National Institutes of Health, argued that the investment that has been made in these cell lines to calibrate them for use in biomedical research cannot be ignored.

Should there be a halt on the use of that mature tool because of its origins that were created in a time when there was a different view? Green asked.

Antonio Regalado, senior editor for biomedicine at MIT Technology Review who writes about the impact of technology on medicine and biomedical research, responded to Greens query.

Regalado brought up the fact that makeup companies have been facing a lot of backlash recently for testing their products on animals. Regalado pointed out that makeup companies could then use a similar argument by saying that since they have already invested money in animal testing procedures, they should not have to find new, less harmful methods of testing.

I don't know that we should rule out the possibility of alternatives if the scientific community decides to put their minds to it. Perhaps an equivalent cell line could be developed, Regalado said.

Diane Hoffman, director of the Law and Health Care Program at the University of Maryland Francis King Carey School of Law, described various perspectives in debate over the ethical concerns of stem cell research.

The challenge, according to Hoffman, is striking a balance between implementing a blanket policy through the government and informing consumers to allow them to make ethical decisions.

Industry wanting innovation, and government wanting safety and efficacy, and consumers wanting access. Those three things are... how we consider these ethical issues, Hoffmann said.

The conversation then shifted to eugenics, the practice of editing human DNA to achieve specific, desirable characteristics, such as eliminating diseases, changing eye color or editing IQ.

Green described an initiative funded by the Human Genome Project, the Ethical, Legal and Social Implications Research Program (ELSI), which focuses on the ethical, legal and social implications of biomedical research.

We can meld together what is scientifically possible to what is the body of evidence of what has come out when we have looked at these ELSI issues and then have conversations... and try to come to consensus on what the guardrails should look like, Green said.

Hoffmann echoed Green, describing the need of the scientific community to also consider allocation of these resources.

Weve got a ways to go in terms of thinking about... how we can be more just in our allocation of medical resources and the benefits of the research were doing, Hoffmann said.

She brought up the idea of giving priority in receiving benefits to vulnerable populations that have been previously harmed by the health-care system.

Wynshaw-Boris added that each study that is conducted needs to address the ELSI considerations mentioned by Green.

Studies have to be done... in partnership with diverse populations, and we have to be committed to that, Wynshaw-Boris said. We have to make progress on it all the time, and that's what we have to be committed to.

The discussion concluded with a consensus among the panelists that the scientific community needs to address social and health inequities as advancements in genetics and genomic techniques continue to occur.

We have to bring more trust to science than exists now, Green said.

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Panelists debate the implications and ethics of stem cell research - Johns Hopkins News-Letter

Amid the news explosion that followed President Trumps COVID-19 diagnosis and brief convalescence earlier this month, there was a nugget you might have missed: The antibody treatment from biotech company Regeneron the president tookseemingly to great effecthad been developed in part by means of cells derived from fetal tissue.

Most of the discussion around this revelation concerned whether it showed the president to be a hypocriteeither personally because of his stated pro-life beliefs, or as a matter of policy because his administration has suspended federal funding for scientific research involving fetal tissue. (Both claims were dubious: There was no reason to believe the president knew the provenance of the Regeneron cocktail when he was treated with it, and the kind of fetal-derived cells used to develop the drug were not included in the administrations funding freeze.)

But the news portended a larger problem that may prove important in months to come: the ethical objections other pro-life people may have to new COVID treatmentsincluding vaccineswith similar issues in their development history.

I think its going to test our convictions about these things, said Dr. C. Ben Mitchell, a professor of moral philosophy at evangelical Union University and senior fellow at the Center for Bioethics & Human Dignity. Whether or not we are going to be consistent with our convictions.

Beyond the central aim of ending legal abortion, no issue has so united the pro-life movement over the last few decades as the push to prevent fetal and embryonic remains from being used in medical research. In the 2000s, the battle involved embryonic stem cell research: President Bush prohibited federal funding for research involving new embryonic stem cell lines in 2001, a policy President Obama reversed in 2009. More recently, the issue has been researchers use of fresh tissue from recent abortions, following activist David Daleidens 2015 expos on Planned Parenthoods practice of selling organs from aborted fetuses to medical research companies.

But while pushing for public policy changes and supply chain reforms to make researchers less reliant on ongoing abortions, pro-lifers have also struggled with a parallel issue on a more personal level: whether its permissible to make use of treatments developed via the use of fetal tissue that already exist. If abortion is evil, they ask themselves, then can I in good conscience allow myself to benefit from medicines that rely on the practice?

Such questions are complicated by the fact that, unlike the tissue research that has dominated pro-life policy space in recent years, many medical products in current use, including a number of childhood vaccines, have a connection to abortion that is distant and tenuous. The cell cultures used in developing such medicines are most accurately described not as fetal cells themselves, but as cells that are fetal-derived: Cells originally taken from an aborted fetus that have been cultivated to multiply freely ever since.

The most widely used of these cell lines date back to just a handful of abortions in Europe in the 1960s. The WI-38 cell line, which has been used to develop vaccines for rubella, rabies, measles, mumps, and various other diseases, is derived from the lung tissue of a fetus aborted in Sweden in 1962; The MRC-5 line, used to produce vaccines for Hepatitis A and polio, dates back to 1966. Other lines are used for other purposes: HEK293 cells, which are derived from fetal kidney cells isolated in the Netherlands in the early 1970s, can be used to create virus-like cells that arent able to infect humans. Researchers use these pseudoviruses to test new therapeutics without having to handle live virus themselves, reducing the need for extreme biosafety precautions in laboratory settings. (The aforementioned Regeneron made use of HEK293 cells in this way.)

These cell cultures wont reproduce infinitely, but saying so almost feels like a technicality: Descendants of the WI-38 and MRC-5 lines have been used to create hundreds of millions of doses of vaccines over the past half-century.

Going by any sort of costbenefit analysis, the use of these cell lines has been a force for good in the world. By making use of the remains of a bare handful of elective abortionsabortions that would have taken place whether or not researchers decided to use thema staggering number of people around the world have been spared the miseries of a whole host of wretched and deadly diseases.

But for those who advocate for decoupling from such practices, simply to use the language of cost and benefit in the first place is to give away the game. If thats the measure, they argue, its hard to see how you could oppose any promising medical research, even the most depraved: How can you weigh the suffering of a few unfortunates against the ongoing benefits to all humanity of curing a deadly disease?

These sorts of ethical questions arent the exclusive domain of the pro-life movement. What posture we ought to take toward ill-gotten medical research is a question that has long occupied bioethicists, given how much of the science underpinning our current understanding and practice of medicine was conducted in unethical waysoften even by the standards of their own time, and even more so by the more exacting standards of the present.

The classic example, of course, is the gruesome human experimentation carried out by Nazi doctors in concentration camps, but there are examples closer to home, too: black men in Alabama whose untreated syphilis was allowed to fester for decades so government researchers could observe the progress of the disease, all the while assuring the subjects they were being treated; developmentally disabled children in New York given chocolate milk laced with feces to deliberately infect them with hepatitis as part of an effort to develop a vaccine.

Other ethical issues involve the origin of immortalized cell cultures in particular. The longevity of these cell lines is such that many of them predate modern medical standards on ethical human research, which werent truly codified until the National Commission for the Protection of Human Subjects of Biomedical and Behavior Research, established by Congress for the purpose in 1974, published its Belmont Report in 1979. The oldest such cell line in existence is a culture of cervical cancer cells taken from a woman named Henrietta Lacks in 1951, who died of the disease that same year. Lacks never consented to having her cells cultured; nor did the women who obtained the abortions that resulted in the WI-38 or MRC-5 cells.

These fraught ethical issues are not a thing of the past. After decades of lobbying, the Lacks family finally won a partial concession from the National Institutes of Health in 2013 to place some restrictions on medical access to information about their relatives cells. Pro-life organizations continually push for researchers to divest from and seek alternatives to fetal cell cultures as well.

For some pro-life bioethicists, the vast distance between the harm of the original abortion and the use of the modern treatment in which it resulted means that, while policymakers and biotech firms still have a moral obligation to work toward developing ethically unproblematic alternatives, individuals dont necessarily have a moral duty to abstain from such treatments themselves. Medical ethics are complicated and a matter of conscience, said Tiffany Manor, who directs the Life Ministry of the conservative Lutheran ChurchMissouri Synod. Some modern medical procedures result from past research that was conducted unethically. That doesnt mean that we ought to throw out all of the beneficial procedures.

But others argue that individuals retain a moral duty to keep pressure on the medical research industry by declining the use of such treatments when possible without creating grave risks to public health. The Catholic Churchs Pontifical Academy for Life tried to strike such a balance when it considered the question in 2005:

On a cultural level, the use of such vaccines contributes in the creation of a generalized social consensus to the operation of the pharmaceutical industries which produce them in an immoral way. Therefore, doctors and fathers of families have a duty to take recourse to alternative vaccines (if they exist), putting pressure on the political authorities and health systems so that other vaccines without moral problems become available. They should take recourse, if necessary, to the use of conscientious objection with regard to the use of vaccines produced by means of cell lines of aborted human foetal origin.

The document goes on:

As regards the diseases against which there are no alternative vaccines which are available and ethically acceptable, it is right to abstain from using these vaccines if it can be done without causing children, and indirectly the population as a whole, to undergo significant risks to their health.

You can see the precarious moral tightrope here: It is good, in the mind of pro-life ethicists, to attempt as much as possible not to participate, however indirectly, in the evil act of a long-ago abortion. But one ought not strain so hard to avoid that participation that one thoughtlessly commits another evil act: allowing oneself or ones children to become vectors of otherwise preventable disease, spreading suffering and even death to those around them.

All this, remember, is just the moral calculus that surrounds such vaccine under normal medical circumstances. Throw in a global pandemic and an unprecedented race to treat and cure it, and you begin to get a sense of the scale of the ethical headaches involved.

Take the issue of Regeneron. Since his own positive experience with the companys antibody cocktail, REGN-COV2, President Trump has become its biggest cheerleader; pushing for it to play a major role in COVID treatment going forward. We have hundreds of thousands of doses that are just about ready. I have emergency use authorization all set, he said on October 7. Youre gonna get better, and youre gonna get better really fast.

But both Regenerons drug and a similar antibody treatment currently being developed by Eli Lilly made use of fetal tissue in their developmentnot in the actual manufacture of the drug, as mentioned above, but in creating neutered pseudoviruses to test its effectiveness.

Imagine a person whose doctor has recommended such a drug trying to make a decision in the light of the moral principles suggested by the Pontifical Academy for Life. On the one hand, the drug is a product of fetal tissue research in only the most remote possible way. But the possibility of endangering others by abstaining does not bear considering here, as the cocktail is a treatment, not a vaccine. Further, it is unclear how a person recommended such a treatment by a doctor ought to think about the question of whether there are ethically acceptable alternatives. Other drugs can help manage COVID, of course, but generally speaking their effect is cumulative: Dexamethasone and remdesivir are not replacements for antibody therapy.

To cap the dilemma off, it isnt as though a pro-life person could start off with unproblematic treatments and work up to REGN-COV2 as a matter of last resort: Patients arent prescribed antivirals or steroids for COVID unless theyre already seriously sick, while antibody treatments like Regenerons have been shown to be helpful only if theyre given very early in the course of the disease, before the bodys own immune response has had a chance to kick in.

COVID vaccines in development present further difficulties. First, we dont actually know which of the many vaccines currently being developed will end up the first to pass muster as a safe, effective, and mass-producible weapon against the pandemic. Many of the candidates do not make use of fetal-derived cells in any capacity. Others use such cells only in confirmatory tests, as with Regeneron. Still others use them in the production of the vaccines themselves.

Of the four vaccines seemingly closest to release in America, twothose being developed by Pfizer and Modernawere merely tested on fetal-derived cells. Two others, from Johnson & Johnson and AstraZeneca, are made with them. The latter vaccines Phase III clinical trials were placed on hold earlier this month, but were resumed last week.

Under ordinary circumstances, this would be a no-brainer: Many pro-life people would simply wait for one of the less objectionable vaccines to become available. But during the coronavirus pandemic, where every day that goes by without a vaccine is critical, what happens if Johnson & Johnson or AstraZenecas product is first past the post, and the federal government invests heavily in its development and distribution?

Its unclear whether such a situation would provoke a legal clash. The federal government doesnt have the constitutional authority to mandate vaccines, but states and cities can; all 50 states require children to receive a battery of vaccines before attending public school, although all offer various exemptions for religious, philosophical, and/or other reasons. Whether citizens have a right to such exemptions, however, is less clear: the Supreme Court has upheld mandatory vaccination programs in the past and has separately ruled that the right to practice religion freely does not include liberty to expose the community or the child to communicable disease.

Theres no reason to believe yet that states will choose to go that route. New York Gov. Andrew Cuomo, whose state was racked by the coronavirus this spring and who last year signed a state law ending religious exemptions for childhood vaccines, is thus far messaging that an eventual COVID vaccine will be available to all New York residents who want one.

The likelier scenario may be that such a clash will instead simply play out in the court of public opinion.

One of the nightmare scenarios Ive been thinking about is, say we get a safe and effective vaccine, and it comes from what many would regard as tainted sources, said Mitchell. And so pro-lifers decide not to use the vaccinethey wont be vaccinated. My guess is that there would be a huge uprising in the society saying, Well, youre posing now a public health risk. We now have a vaccine, but youre choosing not to use it. Youre exposing others to it by not taking the vaccine, or youre going to cost our health care system huge amounts of money in treating you when we have a vaccine that could prevent getting COVID-19, but you choose not to. So I think those are going to be an important test of our convictions.

Photograph by Paul Hennessy/NurPhoto/Getty Images.

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Is the Pro-Life Movement on a Collision Course with the Coronavirus? - The Dispatch

PHILADELPHIA and NEW YORK, Oct. 26, 2020 /PRNewswire/ --Rapid Reshore & Development (RR&D), an alliance of three specialized firms, and BrainStorm Cell Therapeutics, Inc (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced that BrainStorm has selected RR&D as its partner toexpedite site selection and design services for a state-of-the-art manufacturing facility for NurOwn (autologous MSC-NTF) in the U.S.

BrainStorm is investigating NurOwn as a potential treatment for neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). BrainStorm's most advanced clinical program for NurOwn is in ALS, which is currently being evaluated in a pivotal Phase 3 clinical trial.

BrainStorm seeks to locate, design and construct a new commercial manufacturing facility in the U.S. to prepare for potential commercialization. RR&D, a three-firm services alliance consisting of EwingCole, Facility Logix and Biggins, Lacy, Shapiro & Company, will identify the location and develop the design of BrainStorm's new commercial manufacturing facility.

"We're thrilled to be working with BrainStorm on this project and to have the opportunity to deliver this critical work to our region," said EwingCole CEO, Jared Loos, PE, AIA. "We embrace the spirit of creating potentially life-changing technology and we will do everything we can to move the project forward in an efficient and yet responsible manner."

BrainStorm intends to use the facility primarily for cell therapy production. RR&D will provide custom, streamlined project management, site selection analysis and design/construction management services throughout the project's lifecycle.

Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics commented, "Our decision to partner with RR&D was driven by the strong capabilities of the individual partners and their holistic approach to planning, site selection and design services. The expansion of BrainStorm's manufacturing capabilities is a key part of our broader corporate strategy to prepare for potential regulatory approvals of NurOwn and becoming a commercial organization. This new partnership follows our recently announced agreement with Catalent Pharma Solutions to manufacture NurOwn at a scale large enough to meet potential commercial needs at the time of launch. The dedicated, state-of-the-art manufacturing facility developed by RR&D will provide us with important long-term autonomy and strategic flexibility, including the capacity to supply NurOwn for additional disease indications beyond ALS. Together these two partnerships will help ensure that BrainStorm has the manufacturing capacity to meet the needs of patients today and well into the future."

Site selection analyses will begin immediately with the goal of identifying locations that offer a cost-effective solution for BrainStorm's new manufacturing facility. At the same time, the design team will begin developing a conceptual design of the manufacturing facility, based upon input from BrainStorm's process, engineering, and scientific staff, by defining the main steps of the production process and Current Good Manufacturing Practices (cGMP) requirements. The approximately 50,000 square-foot building will contain manufacturing suites, complementary support and infrastructure, and the ability to expand the facility to 100,000 square feet to anticipate future programmatic needs.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc.is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from theU.S. Food and Drug Administration(FDA) and theEuropean Medicines Agency(EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at sixU.S.sites supported by a grant from theCalifornia Institute for Regenerative Medicine(CIRM CLIN2-0989). The pivotal study is intended to support a filing forU.S.FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently receivedU.S.FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) completed enrollment inAugust 2020. For more information, visit the company's website atwww.brainstorm-cell.com.

About Rapid Reshore & Development:

Rapid Reshore & Development is an alliance of expert firms providing confidence and support throughout the life sciences industry, representing an evolution from transaction-driven service models to a holistic focus on client needs, integrating an interdisciplinary team customized for a variety of individual projects. To optimize and strengthen confidence in decision-making and speed-to-market, Rapid Reshore & Development alliance was formed to deliver best-in-class professionals with deep experience in all aspects of life sciences' project planning, site selection, design and execution including financial, labor market, development incentives, real estate, design and engineering, and construction management.For additional information, visit: http://www.rapidreshore.com

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Brainstorm:Investor Relations: Corey Davis, Ph.D. LifeSci Advisors, LLC Phone: +1 646-465-1138[emailprotected]

Media:Paul TyahlaSmithSolvePhone: + 1.973.713.3768[emailprotected]

Rapid Reshore & Development (RR&D):Media Contact:Zachary DeRitisCommunications Specialist215-409-4249[emailprotected]

SOURCE BrainStorm Cell Therapeutics Inc.; Rapid Reshore & Development (RR&D)

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Rapid Reshore & Development and BrainStorm Cell Therapeutics Announce Agreement to Advance Construction of BrainStorm's US Manufacturing Facility...

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BEIJING, China, Nov. 02, 2020 (GLOBE NEWSWIRE) -- Li Auto Inc. (Li Auto or the Company) (Nasdaq: LI), an innovator in Chinas new energy vehicle market, today announced that in October 2020 the Company delivered 3,692 Li ONEs, representing a steady increase compared to September. In October, the Company also achieved strong orders, setting a new monthly record. 2020 Q12020 Q22020 Q32020 JanOct Deliveries2,8966,6048,66021,852 As of October 31, 2020, the Company had 41 retail stores covering 36 cities. Going forward, the Company plans to continue strengthening its direct sales and servicing network to further bolster its footprint and market penetration in China.About Li Auto Inc.Li Auto Inc. is an innovator in Chinas new energy vehicle market. The Company designs, develops, manufactures, and sells premium smart electric SUVs. Through innovative products, technology, and business model, the Company provides customers with safe, convenient, and cost-effective mobility solutions. Li Auto is the first to successfully commercialize extended-range electric vehicles in China. The Company started volume production of its first model, Li ONE, in November 2019. With Li ONE, the Company leverages its in-house technology to create value for its customers, focusing on range extension, smart technology, and autonomous driving solutions. Beyond Li ONE, the Company aims to expand its product line by developing new vehicles to target a broader consumer base.For more information, please visit: http://ir.lixiang.com.Safe Harbor StatementThis press release contains statements that may constitute forward-looking statements pursuant to the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as will, expects, anticipates, aims, future, intends, plans, believes, estimates, likely to, and similar statements. Li Auto may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the SEC), in its annual report to shareholders, in press releases and other written materials, and in oral statements made by its officers, directors, or employees to third parties. Statements that are not historical facts, including statements about Li Autos beliefs, plans, and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: Li Autos strategies, future business development, and financial condition and results of operations; Li Autos limited operating history; risks associated with extended-range electric vehicles, Li Autos ability to develop, manufacture, and deliver vehicles of high quality and appeal to customers; Li Autos ability to generate positive cash flow and profits; product defects or any other failure of vehicles to perform as expected; Li Autos ability to compete successfully; Li Autos ability to build its brand and withstand negative publicity; cancellation of orders for Li Autos vehicles; Li Autos ability to develop new vehicles; and changes in consumer demand and government incentives, subsidies, or other favorable government policies. Further information regarding these and other risks is included in Li Autos filings with the SEC. All information provided in this press release is as of the date of this press release, and Li Auto does not undertake any obligation to update any forward-looking statement, except as required under applicable law.For investor and media inquiries, please contact:Li Auto Inc. Investor Relations Email: ir@lixiang.comThe Piacente Group, Inc. Yang Song Tel: +86-10-6508-0677 Email: Li@tpg-ir.comBrandi Piacente Tel: +1-212-481-2050 Email: Li@tpg-ir.com

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Will Trevor Lawrence stay at Clemson to avoid the Jets? - Yahoo! Voices

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BEIJING, China, Nov. 02, 2020 (GLOBE NEWSWIRE) -- Li Auto Inc. (Li Auto or the Company) (Nasdaq: LI), an innovator in Chinas new energy vehicle market, today announced that in October 2020 the Company delivered 3,692 Li ONEs, representing a steady increase compared to September. In October, the Company also achieved strong orders, setting a new monthly record. 2020 Q12020 Q22020 Q32020 JanOct Deliveries2,8966,6048,66021,852 As of October 31, 2020, the Company had 41 retail stores covering 36 cities. Going forward, the Company plans to continue strengthening its direct sales and servicing network to further bolster its footprint and market penetration in China.About Li Auto Inc.Li Auto Inc. is an innovator in Chinas new energy vehicle market. The Company designs, develops, manufactures, and sells premium smart electric SUVs. Through innovative products, technology, and business model, the Company provides customers with safe, convenient, and cost-effective mobility solutions. Li Auto is the first to successfully commercialize extended-range electric vehicles in China. The Company started volume production of its first model, Li ONE, in November 2019. With Li ONE, the Company leverages its in-house technology to create value for its customers, focusing on range extension, smart technology, and autonomous driving solutions. Beyond Li ONE, the Company aims to expand its product line by developing new vehicles to target a broader consumer base.For more information, please visit: http://ir.lixiang.com.Safe Harbor StatementThis press release contains statements that may constitute forward-looking statements pursuant to the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as will, expects, anticipates, aims, future, intends, plans, believes, estimates, likely to, and similar statements. Li Auto may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the SEC), in its annual report to shareholders, in press releases and other written materials, and in oral statements made by its officers, directors, or employees to third parties. Statements that are not historical facts, including statements about Li Autos beliefs, plans, and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: Li Autos strategies, future business development, and financial condition and results of operations; Li Autos limited operating history; risks associated with extended-range electric vehicles, Li Autos ability to develop, manufacture, and deliver vehicles of high quality and appeal to customers; Li Autos ability to generate positive cash flow and profits; product defects or any other failure of vehicles to perform as expected; Li Autos ability to compete successfully; Li Autos ability to build its brand and withstand negative publicity; cancellation of orders for Li Autos vehicles; Li Autos ability to develop new vehicles; and changes in consumer demand and government incentives, subsidies, or other favorable government policies. Further information regarding these and other risks is included in Li Autos filings with the SEC. All information provided in this press release is as of the date of this press release, and Li Auto does not undertake any obligation to update any forward-looking statement, except as required under applicable law.For investor and media inquiries, please contact:Li Auto Inc. Investor Relations Email: ir@lixiang.comThe Piacente Group, Inc. Yang Song Tel: +86-10-6508-0677 Email: Li@tpg-ir.comBrandi Piacente Tel: +1-212-481-2050 Email: Li@tpg-ir.com

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Spurs' Becky Hammon honored with impressive San Antonio mural - Yahoo! Voices

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Global Smart Food and Beverage Label Market to Reach $51. 9 Million by 2029. Market Report Coverage - Smart Food and Beverage Label. Market Segmentation.New York, Nov. 02, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Smart Food and Beverage Label Market: Focus on Product Type, Application, Industry Analysis and Region Analysis Forecast, 2019-2029" - https://www.reportlinker.com/p05982085/?utm_source=GNW Product Type - RFID, NFC, Temperature Sensing Labels, Others Application - Food, Beverages Regional Segmentation North America U.S., Canada Europe Germany, France U.K. Asia-Pacific and Japan Australia and New Zealand, Japan, and India China Growth Drivers Growing Consumer Demands for Food Authentication Ability of Smart Labels to Enhance Food Safety and Reduce Food Waste Adoption and Implementation of Smart Food Labels by Major Food and Beverage Industry Manufacturers Market Challenges High Implementation Cost for the Smart Food Label Lack of Consumer Knowledge and Accessibility Disproportionality Market Opportunities Growing Confidence and Increasing Consumer Dependence on IoT Technologies Growing Need for Smart Inventory Management in Retail Industry Key Companies Profiled Avery Dennison Corporation, CCL Industries Inc., Honeywell International Inc., Label Insight, Inc., and Sato Holding Corporation, among others Key Questions Answered in this Report: What is the expected global smart food and beverage label market size in terms of value during the period 2018-2029? What are the labeling challenges faced by the food and beverage manufacturers? What is the on-going initiative to transform the global smart food and beverage label market? Which region is the largest market for the global smart food and beverage label market? What is the expected future scenario and the revenue generation by different geographical regions and countries in the smart food and beverage label market such as North America, South America, the U.K., Europe, the Middle East and Africa, China, and Asia-Pacific and Japan? What is the impact of COVID-19 on the smart food and beverage label market? Which product type is currently dominating the smart food and beverage label market, and which is likely to dominate in the future? What are the emerging trends in the global smart food and beverage label market? What are the market dynamics of the global smart food and beverage label market, including market drivers, restraints, and opportunities? What are the major market driving trends for the global smart food and beverage label market in terms business model, market consolidation, and new product offerings? Market Overview The adoption of smart labels has witnessed a sharp increase in the food industry as demand for product authentication and the ability to improve food safety continues to rise.Having connected packaging solutions like smart labels allows end consumers to access all traceable information across the supply chain. Smart labeling provides consumers with a digital source of nutrition, ingredients, allergen, and additional information which may or may not appear on the physical label printed on the packaging or attached to the product itself. Moreover, smart labels also help the consumer to pursue a wide range of products from design to shelf. The rising number of customers with access to packaged food is proliferating relative to the worlds population.The purchasing power of the customer for packaged food, on the other hand, is also growing. The growth in smart labeling is increasing with more and more expenditure on packaged food.Food authenticity evaluation has been required rapidly in the food and beverage industry. The evaluation ensures the originality and safety of any food product that comes into the market.This evaluation is achieved by using specific advanced methods and techniques. Some of the ways include Radio Frequency Identification (RFID) labels that can be attached to food products and can use electromagnetic fields to track products through the supply chain automatically. It brings traceability to the product, which is essential to trace the source of food and avoid counterfeit products. Within the research report, the market is segmented based on product type, application, and region. Each of these segments covers the markets snapshot of the propensity of market revenue, underlying patterns, and trends over the projected years by using analytics on the primary and secondary data obtained. Competitive Landscape The rise in the adoption of smart labeling in the food and beverage industry across the globe has led companies to invest in this industry.The competitive landscape for the smart food and beverage label market demonstrates an inclination toward companies adopting strategies such as product launches along with partnerships and collaborations. The result of the emerging strategies and developments is already surging the market in the form of product launch and developments. Driven by the rapid evolution of the food packaging sector, there has been swift growth in research and development activities by many important players in this market, leading to an increase in the number of product launches and developments since 2017. For instance, in July 2020, Label Insight, Inc. launched Explore Market Navigator, which will help CPG manufacturers improve online discoverability and increase the sales of their products. The business expansion strategy has also been significantly employed for the expansion in the smart food and beverage label market.As the global market continues to expand, businesses operating in this sector are forced to develop collaborative strategies in order to maintain themselves in an extremely competitive market. Key players are also engaging in business expansions in regions where there is a strong demand for smart labeled products.Industry leaders in this market are actively opting for this strategy to improve their market position. For instance, in April 2020, Label Insight, Inc., expanded its operations in the Canadian market to offer SmartLabel and accelerate the adoption of SmartLabel to support the needs of customers. Countries Covered North America U.S. Canada Europe Germany France U.K. China Asia-Pacific and Japan Japan Australia and New Zealand IndiaRead the full report: https://www.reportlinker.com/p05982085/?utm_source=GNWAbout ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.__________________________CONTACT: Clare: clare@reportlinker.comUS: (339)-368-6001Intl: +1 339-368-6001

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Total Student Enrollment of China New Higher Education Group Achieves Strong Organic Growth to a New Record High -- Total Number of Enrolled Students...

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Global Smart Food and Beverage Label Market to Reach $51. 9 Million by 2029. Market Report Coverage - Smart Food and Beverage Label. Market Segmentation.New York, Nov. 02, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Smart Food and Beverage Label Market: Focus on Product Type, Application, Industry Analysis and Region Analysis Forecast, 2019-2029" - https://www.reportlinker.com/p05982085/?utm_source=GNW Product Type - RFID, NFC, Temperature Sensing Labels, Others Application - Food, Beverages Regional Segmentation North America U.S., Canada Europe Germany, France U.K. Asia-Pacific and Japan Australia and New Zealand, Japan, and India China Growth Drivers Growing Consumer Demands for Food Authentication Ability of Smart Labels to Enhance Food Safety and Reduce Food Waste Adoption and Implementation of Smart Food Labels by Major Food and Beverage Industry Manufacturers Market Challenges High Implementation Cost for the Smart Food Label Lack of Consumer Knowledge and Accessibility Disproportionality Market Opportunities Growing Confidence and Increasing Consumer Dependence on IoT Technologies Growing Need for Smart Inventory Management in Retail Industry Key Companies Profiled Avery Dennison Corporation, CCL Industries Inc., Honeywell International Inc., Label Insight, Inc., and Sato Holding Corporation, among others Key Questions Answered in this Report: What is the expected global smart food and beverage label market size in terms of value during the period 2018-2029? What are the labeling challenges faced by the food and beverage manufacturers? What is the on-going initiative to transform the global smart food and beverage label market? Which region is the largest market for the global smart food and beverage label market? What is the expected future scenario and the revenue generation by different geographical regions and countries in the smart food and beverage label market such as North America, South America, the U.K., Europe, the Middle East and Africa, China, and Asia-Pacific and Japan? What is the impact of COVID-19 on the smart food and beverage label market? Which product type is currently dominating the smart food and beverage label market, and which is likely to dominate in the future? What are the emerging trends in the global smart food and beverage label market? What are the market dynamics of the global smart food and beverage label market, including market drivers, restraints, and opportunities? What are the major market driving trends for the global smart food and beverage label market in terms business model, market consolidation, and new product offerings? Market Overview The adoption of smart labels has witnessed a sharp increase in the food industry as demand for product authentication and the ability to improve food safety continues to rise.Having connected packaging solutions like smart labels allows end consumers to access all traceable information across the supply chain. Smart labeling provides consumers with a digital source of nutrition, ingredients, allergen, and additional information which may or may not appear on the physical label printed on the packaging or attached to the product itself. Moreover, smart labels also help the consumer to pursue a wide range of products from design to shelf. The rising number of customers with access to packaged food is proliferating relative to the worlds population.The purchasing power of the customer for packaged food, on the other hand, is also growing. The growth in smart labeling is increasing with more and more expenditure on packaged food.Food authenticity evaluation has been required rapidly in the food and beverage industry. The evaluation ensures the originality and safety of any food product that comes into the market.This evaluation is achieved by using specific advanced methods and techniques. Some of the ways include Radio Frequency Identification (RFID) labels that can be attached to food products and can use electromagnetic fields to track products through the supply chain automatically. It brings traceability to the product, which is essential to trace the source of food and avoid counterfeit products. Within the research report, the market is segmented based on product type, application, and region. Each of these segments covers the markets snapshot of the propensity of market revenue, underlying patterns, and trends over the projected years by using analytics on the primary and secondary data obtained. Competitive Landscape The rise in the adoption of smart labeling in the food and beverage industry across the globe has led companies to invest in this industry.The competitive landscape for the smart food and beverage label market demonstrates an inclination toward companies adopting strategies such as product launches along with partnerships and collaborations. The result of the emerging strategies and developments is already surging the market in the form of product launch and developments. Driven by the rapid evolution of the food packaging sector, there has been swift growth in research and development activities by many important players in this market, leading to an increase in the number of product launches and developments since 2017. For instance, in July 2020, Label Insight, Inc. launched Explore Market Navigator, which will help CPG manufacturers improve online discoverability and increase the sales of their products. The business expansion strategy has also been significantly employed for the expansion in the smart food and beverage label market.As the global market continues to expand, businesses operating in this sector are forced to develop collaborative strategies in order to maintain themselves in an extremely competitive market. Key players are also engaging in business expansions in regions where there is a strong demand for smart labeled products.Industry leaders in this market are actively opting for this strategy to improve their market position. For instance, in April 2020, Label Insight, Inc., expanded its operations in the Canadian market to offer SmartLabel and accelerate the adoption of SmartLabel to support the needs of customers. Countries Covered North America U.S. Canada Europe Germany France U.K. China Asia-Pacific and Japan Japan Australia and New Zealand IndiaRead the full report: https://www.reportlinker.com/p05982085/?utm_source=GNWAbout ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.__________________________CONTACT: Clare: clare@reportlinker.comUS: (339)-368-6001Intl: +1 339-368-6001

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Elis announces the acquisition of 3 laundries in Brazil - Yahoo Finance UK

The global stem cell banking market was valued at $1,986 million in 2016, and is estimated to reach $6,956 million by 2023, registering a CAGR of 19.5% from 2017 to 2023. Stem cell banking is a process where the stem cell care isolated from different sources such as umbilical cord and bone marrow that is stored and preserved for future use. These cells can be cryo-frozen and stored for decades. Private and public banks are different types of banks available to store stem cells.

Top Companies Covered in this Report: Cord Blood Registry,ViaCord,Cryo-Cell, China Cord Blood Corporation, Cryo-Save, New York Cord Blood Program, CordVida, Americord, CryoHoldco, Vita34

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Increase in R&D activities in regards with applications of stem cells and increase in prevalence of fatal chronic diseases majorly drive the growth of the global stem cell banking market. Moreover, the large number of births occurring globally and growth in GDP & disposable income help increase the number of stem cell units stored, which would help fuel the market growth. However, legal and ethical issues related to stem cell collections and high processing & storage cost are projected to hamper the market growth. The initiative taken by organizations and companies to spread awareness in regards with the benefits of stem cells and untapped market in the developing regions help to open new avenues for the growth of stem cell banking market in the near future.

The global stem cell banking market is segmented based on cell type, bank type, service type, utilization, and region. Based on cell type, the market is classified into umbilical cord stem cells, adult stem cells, and embryonic stem cells. Depending on bank type, it is bifurcated into public and private. By service type, it is categorized into collection & transportation, processing, analysis, and storage. By utilization, it is classified into used and unused. Based on region, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA.

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Table Of Content

CHAPTER 1: INTRODUCTION

CHAPTER 2: EXECUTIVE SUMMARY

CHAPTER 3: MARKET OVERVIEW

CHAPTER 4: STEM CELL BANKING MARKET, BY CELL TYPE

CHAPTER 5: STEM CELL BANKING MARKET, BY BANK TYPE

CHAPTER 6: STEM CELL BANKING MARKET, BY SERVICE TYPE

CHAPTER 7: STEM CELL BANKING MARKET, BY UTILIZATION

CHAPTER 8: STEM CELL BANKING MARKET, BY REGION

CHAPTER 9: COMPANY PROFILES

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Stem Cell Banking Market is forecast to reach $6,956 million by 2023 | ViaCord,Cryo-Cell, China Cord Blood Corporation, Cryo-Save - The Daily...

Over the last 15 years, Californias stem cell agency has spent $2.7 billion on research ranging from arthritis and blindness to cancer and incontinence. The vast majority of the money has gone to enterprises that have ties to members of the agencys governing board.

All of which is legal. All of which is not likely to change.

Eight out of every ten dollars that agency has handed out have been collected by 25 institutions such as Stanford University, multiple campuses of the University of California and scientific research organizations. Their combined total exceeds $2.1 billion.

All 25 have links directly or indirectly to past or present members of the board of the agency, according to an analysis by the California Stem Cell Report, which has covered the agency since 2005.

They (the agencys directors) make proposals to themselves, essentially, regarding what should be funded. They cannot exert independent oversight, says Harold Shapiro, who led a 2012 study of the agency by the prestigious Institute of Medicine (IOM), which is now called the National Academy of Medicine. The study recommended a major restructuring of the agencys board to help deal with the problem.

The longstanding, conflict-of-interest issues are not addressed in Proposition 14 on the Nov. 3 ballot. The measure would give the agency, officially known as the California Institute for Regenerative Medicine (CIRM), $5.5 billion more and expand its scope of activities and research. The ballot measure is likely to increase the problems by increasing the size of the agencys governing board from 29 to 35.

Another ballot initiative, Proposition 71, created Californias stem cell program in 2004. Ever since, conflict of interest questions have dogged CIRM. Indeed, critics of the agency can today point to the top five recipients of CIRM largess as examples of conflict problems. Stanford University ranks as the No. 1 recipient with $388 million. UCLA is No. 2 with $307 million. It is followed by UC San Diego, $232 million; UC San Francisco, $199 million, and UC Davis, $143 million.

All have had a representative on the CIRM board since the inception of the program.

Editors note CIRMs totals may change slightly as the result of the agencys internal accounting procedures.

IOM and public confidence in CIRMThe IOM study, with its criticism of conflicts, was commissioned by CIRM at a cost of $700,000. Directors expected that it would provide a gold standard evaluation of the agency that would support a ballot measure for additional funding. The studys scope went well beyond conflicts of interest. In fact, it said it did not search for evidence of specific conflicts because the task was not part of the agreement with CIRM. The IOM did say that studies from psychology and behavioral economics show that conflict of interest leads to unconscious and unintentional self-serving bias and to a bias blind spot that prevents recognition of ones own bias. While all of the studys findings were consequential, the matter of conflicts attracted the most public attention.

Ties to stem cell board lucrative, said a headline in the Orange County Register shortly after the IOM report was released.

The agency has used more than half of its funding and one day will almost certainly want to ask taxpayers for more. It should remember that voters will look for evidence of public accountability as well as respected research, said the Los Angeles Times in an editorial in December 2012.

The IOM report itself said, Far too many board members represent organizations that receive CIRM funding or benefit from that funding. These competing personal and professional interests compromise the perceived independence of the ICOC (the CIRM governing board), introduce potential bias into the boards decision making, and threaten to undermine confidence in the board.

The IOM said the composition of the board makes it neither independent nor capable of oversight, although the board is legally dubbed the Citizens Independent Oversight Committee (ICOC).

Placing deans of medical schools and patient advocates on the board who are linked to specific diseases raises questions about whether decisions delegated to the boardparticularly decisions about the allocation of fundswill be made in the best interests of the public or will be unduly influenced by the special interests of board members and the institutions they represent. Such conflicts, real or perceived, are inevitable.

The situation involves more than legalisms. Properly understood, the IOM said, conflict of interest is not misconduct, but bias that skews the judgment of a board member in favor of interests that may be different from or narrower than the broader interests of the institution.

The IOM study additionally surveyed board members about conflicts of interest and reported, While a majority of respondents stated that personal interests did not play a role in their work on the ICOC, some responses were more equivocal. One respondent replied that it was hard to tell given that so many decisions take place off camera in secret meetings, while another acknowledged that ICOC members are human, and, of course, their decisions are influenced by personal beliefs and interests.

The inherent conflictsThe conflicts were built in by Proposition 71, which dictated the composition of CIRMs 29-member board. CIRMs general counsel, James Harrison, once described the situation as inherent conflicts of interest.

Under Proposition 71, representatives from virtually all the California institutions that stood to benefit were given seats at the table where spending plans are approved and awards handed out. Directors are not allowed to vote on specific awards to their institution. But they control the direction of the agency and what CIRM calls concept plans, including specific elements and budgets for the award rounds. Some of those rounds run into hundreds of millions of dollars.

One of the concept plans created a $47 million program to help California institutions recruit star scientists to the Golden State. Another plan created the $50 million Alpha Clinic Network at five academic centers all connected to board members.

Following the IOM report, the CIRM board did remove most institutional directors from meetings where awards are ratified. Jonathan Thomas, chair of the board, declared then that financial conflict issues were put to bed once and for all, a position that the agency holds today. In May 2019, Thomas told directors that several authoritative entities have studied CIRM and produced written reports that dealt with conflict matters.

Thomas said, Each had in it sort of quite vehement language about the conflict of interest issue, which has always been just perceived..With respect to any given funding award, theres never been an actual conflict.

During the 2019 meeting, the board did not discuss issues involving board action on concept plans. They continue today to modify and approve concept plans.

Beyond the CIRM boardConflicts of interest at CIRM go beyond the 29-member board. In 2014, the agency was shocked by a case involving a former president of the agency, Alan Trounson, and StemCells, Inc., a company that was awarded $40 million while he was serving as the top executive at CIRM. (The company later declined one of the awards.) Only seven days after his final day at CIRM, Trounson was named to the board of directors of StemCells, Inc.

He served on the companys board for about two years and received $443,500 in total compensation, including stock options, according to StemCells, Inc., documents filed with the Securities and Exchange Commission.

Following the announcement of the Trounson appointment, CIRM looked into some of Trounsons work at CIRM. In July of 2014, the agency said that its severely limited investigation found no evidence that its former president attempted to influence action on behalf of StemCells, Inc., during the previous month. The states political ethics agency, the Fair Political Practices Commission, said in a Feb. 6, 2015, letter to Trounson that there was insufficient evidence to demonstrate a legal violation.

Even before the agency was created, critics warned of conflict-of-interest problems. Writing in an opinion piece in October 2004 in the San Francisco Chronicle, David Winickoff, then a professor at UC Berkeley, said, Contrary to what its name suggests, the ICOC is neither independent of interest-group politics nor does it include any citizen members. Hard- driving university scientists, disease group advocates and private industry executives who will make up the ICOC all have vested interests in how the money is to be used.

A sampling of conflictsThe California Stem Cell Report, which calculated the percentage of awards linked to institutional directors, has chronicled the conflicts issues at CIRM over the past 15 years. In 2012, its analysis showed that 92 percent of awards had been collected by institutions tied to past and present directors. The figure dropped to 79 percent by this summer as the types of grantees have widened. Here is a sampling of conflict issues that have surfaced publicly over the years.

In 2007, violations involving five board members resulted in voiding applications from 10 researchers seeking $31 million. The applications included letters of support signed by deans of medical schools who also sat on the CIRM board of directors. Directors are barred from attempting to influence a decision regarding a grant. The agency blamed its employees for the problem.

In 2008, public complaints by one applicant from industry about conflicts of interest on the part of a reviewer were briefly aired at a public board meeting. The then chair of the CIRM board, Robert Klein, told the applicant the board needed instead to discuss naming CIRM-funded labs and then go to lunch. CIRM later refused to release the letter from the applicant detailing the problem.

In 2009, board member John Reed, then CEO of the Sanford-Burnham Institute, was warned by the states Fair Political Practices Commission about his violation of conflict of interest rules. Reed intervened with CIRM staff on behalf of a $638,000 grant to his organization. Reed took his action at the suggestion of then CIRM Chair Klein, an attorney who led the drafting of Proposition 71.

Also in 2009, then board member Ted Love, who had deep connections in the biomedical industry, served double duty for the agency. He was the interim chief scientific officer and helped to develop the agencys first, signature $225 million disease team round while he was still serving on the board. As chief scientific officer, Love would have had access to proprietary information and trade secrets in grant applications.

When questioned, CIRM said that Love would serve only as a part-time advisor to the agency president, not as chief scientific officer. Nonetheless, in 2012, the board adopted a resolution with high praise for Love and his performance specifically as the chief scientific officer.

Beginning in 2010, a stem cell firm, iPierian,Inc., whose major investors contributed nearly $6 million to the ballot measure that created the stem cell agency, received $3.9 million in awards from the agency. The contributions were 25 percent of the total in the campaign, which was headed by Bob Klein. (See here and see here.)

In 2011, the chairman of the CIRM grant review group resigned from his position as the result of another violation, which the agency felt necessary to report to the California legislature. John Sladek, former president of Cal Lutheran University in Los Angeles, co-authored scientific publications with a researcher who was listed as a consultant on a CIRM grant application.

In 2012, StemCells, Inc., was awarded $40 million by the CIRM board despite having one of its $20 million applications rejected twice by grant reviewers. The action came after the board was vigorously lobbied by Klein, who had left his post as chair the previous year. Klein, who ran the Proposition 71 campaign, had campaign connections to researcher Irv Weissman of Stanford, who founded StemCells, Inc., and was on its board. Weissman was featured in a TV campaign ad for Proposition 71 and helped to raise millions for the 2004 ballot campaign.

The StemCells, Inc., awards were the first time that CIRM had approved that much money for one company, and the first time Klein lobbied his former board.

In 2012, an incident surfaced that illustrated how non-profit, disease-oriented organizations sometimes expect increased funding as the result of the appointment of sympathetic individuals to the board. That occurred when Diane Winokur was appointed to the board as a patient advocate. The chief scientist for The ALS Association, said Winokur will be a tremendous asset in moving the ALS research field forward through CIRM funding.

The IOM study identified as a problem the personal conflicts of interest involving the 10 patient advocates on the board. It said, (P)ersonal conflicts of interest arising from ones own or a family members affliction with a particular disease or advocacy on behalf of a particular disease also can create bias for board members.

In 2013, internationally renowned scientist Lee Hood, winner of a National Medal of Science, violated the conflict of interest rules of the California stem cell agency when he was involved in reviewing applications in a $40 million round to create genomics centers in California. The conflict involved connections between Hood, Weissman and Trounson. It was not discovered by the agency during the closed-door review and was raised by another reviewer at the end of the review. The review had to be redone later in the year.

Hood never commented publicly, but CIRM said he acknowledged the conflict.

In January 2014, the genomics round surfaced again. The applications were by then before the CIRM board for public ratification of reviewers decisions. The reviewers actions are taken behind closed doors with no public disclosure of reviewers personal, professional or economic conflicts.

The genomics round riled some researchers who complained publicly in letters to the agencys board about unfairness, apparent preferential treatment and manipulation of scores.

Only seven of the 29 members of the 29-member board could vote on the applications. Conflicts of interest and CIRM rules barred the rest from voting. The final vote on the award was 6-1 for a group led by Stanford. Two years earlier, however, when the concept plan was approved by the CIRM board, no directors were disqualified, even though some of their institutions were likely to benefit. The plan was approved on a show of hands. The transcript of the meeting does not indicate any negative votes or absentions.

The hidden review processUnder CIRMs rules, the scientists who review the applications must come from out-of-state. They do not have to disclose publicly their economic, personal or professional conflicts despite the fact that they make the de facto decisions on the applications. The board rubber stamps nearly all of the reviewers actions to approve funding. A CIRM examination of the practice in 2013 showed that 98 percent of reviewers decisions were ratified by the board. Since then, the agency has not produced a similar report. Occasionally, however, the board will approve an application that was not recommended for funding.

The CIRM governing board has resisted requiring public disclosure of the interests of reviewers. The subject has come up several times, but board members have been concerned about losing reviewers who would not be pleased about disclosing their financial and other interests.

Nonetheless, public disclosure of economic interests among researchers is routine in scientific research articles. Many universities, including Stanford, also require public disclosure of financial interests of their researchers.

At the time of Hood-Weissman-Trounson flap, Stanfords policy said, No matter what the circumstances if an independent observer might reasonably question whether the individuals professional actions or decisions are determined by considerations of personal financial gain, the relationship should be disclosed to the public during presentations, in publications, teaching or other public venues.

Proposition 71 placed the legal authority for grant approvals in the hands of the CIRM board. Traditionally in the world of science, other scientists ( peer reviewers), however, are deemed to be the most capable of making the scientific decisions about grant applications. The traditional practice calls for the reviewers to be anonymous and meet in private, which is also CIRMs practice.

If the CIRM board concedes the decisions to the grant reviewers, state law is likely to require public disclosure of their financial interests, a move that the board has opposed for years. Former CIRM Chairman Klein repeatedly advised the board during its public grant approval processes that reviewers actions were only recommendations, and that the board was actually making the decisions.

Proposition 14 implicitly recognizes, however, that a problem exists with directors approving concept plans for awards that could benefit their institutions.

To ease that problem legally, Klein inserted language in the new proposition that excludes adoption of strategic plans, concept plans and research budgets from being considered as matters involving conflicts of interest.

The measure does nothing to deal with matters involving the de facto, closed-door approval of awards by researchers who are unknown to the public and who do not have to publicly disclose their interests.

At the time the IOM report was released nearly eight years ago, some board members complained that its recommendations were unrealistic because of the likely, lengthy difficulties of altering a state law that had been created by the initiative. But since then, directors have not asked state lawmakers to change the structure of the board or to comply with the other $700,000 worth of IOM recommendations.

CIRM directors, however, missed an opportunity last year to seek conflict-easing changes through the $5.5 billion stem cell measure now on the ballot, Proposition 14.

Some board members have said they discussed the initiative privately with Bob Klein, who crafted the proposal last year.

Revision of CIRMs conflict rules was discussed at a board meeting in May 2019. Several board members expressed concerns about the loss of valuable insights from board members who cannot vote on applications. Some also expressed concerns about whether loosening the rules would damage the possibility of voter approval of a ballot measure to refinance the agency. Several, including CIRM Chair Thomas, also said theres never been a conflict involving a funding award and a board member. No action involving conflicts was taken at the meeting.Editors Note: DavidJensen is a retired newsman who has followed the affairs of the $3 billion California stem cell agency since 2005 via his blog, the California Stem Cell Report. He has published thousands of items on California stem cell matters in the past 11 years. This story was an excerpt from his upcoming book, Californias Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures, which s available for pre-order on Amazon.

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Those linked to stem cell board received more than $2.1 billion - Capitol Weekly

Stem cells offer hope as a promising treatment option for various diseases and are the future of medicine. Embryonic stem cells, have been at the heart of many debates globally, in view of the embryonic destruction or manipulation that their generation may require. Converging between research and law, patent law and policy grant yet throw their own challenges to obtaining exclusivity.

In India, in addition to satisfying the criteria of novelty and inventive step, inventions need to fall outside the realm of Section 3 of the Patents Act, to be patentable. Presenting an additional bar to patentability, Section 3 enlists inventions which are not patentable. Owing to this section it is oftentimes the case that the claim scope granted in India is quite different from that granted in other jurisdictions.

Public order and morality

Over the years, the Indian Patent Offices perspective on the issue of patentability of inventions involving embryonic stem cells, appears to have changed. This change in stance is apparent from the changes in the Manual of Patent Office Practice and Procedure. The 2005 draft of said guidelines treated the use of human or animal embryos for any purpose against public order and morality and prohibited the same from patentability. This restriction however, was removed from the subsequent draft of the guidelines and has not reappeared ever since.

Inspite of this change in the guidelines, the Patent Office till date raises the public order and morality objection under section 3(b) of the Patents Act, on stem cell related inventions (both methods and stem cell products). The concern most frequently expressed is the possibility of destruction of human embryos. The prosecution history of several cases shows that an objection on public order and morality has been raised even if the claims do not call out embryonic stem cells but the specification mentions the possibility of use of embryonic stem cells. The objection is frequently overcome by excluding any reference to embryonic stem cells from the claims and by disclaiming the use of embryonic stem cells in the operation of the invention.

However, the approach of treating stem cell research against public order and morality appears to be in contrast to public policy in India. The National Guidelines for Stem Cell Research (published by ICMR and DBT under the Ministry of Science and Technology) prescribe conditions subject to which research on stem cells should be conducted. The conditions include verification that the blastocysts used are spare embryos. The guidelines also permit establishment of new human embryonic stem cell lines from spare embryos subject to the approval of certain committees. Clearly, these government guidelines permit safe and responsible stem cell research, including research on embryonic stem cells.

Moreover, it is a well-known fact that not every invention involving embryonic stem cells would necessitate destruction of human embryos and a lot of research is based on embryonic stem cell lines. Therefore, the indiscriminate imposition of objections under Section 3(b) requires change.

Parts of Plants or Animals and Products of Nature

While claims relating to methods of isolation and propagation of stem cells are frequently granted, the Indian Patent Office appears to have never granted even a single application with claims directed to stem cells per se.

This brings us to another common objection frequently encountered in stem cell applications, namely, Section 3(j) which prohibits from patentability plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals. Another commonly encountered objection is of Section 3(c) which bars the patentability of any living thing or non-living substance occurring in nature.

There is no judicial precedent that could throw light on what exactly constitutes parts of plants and animals under Section 3(j). The Patent Office considers any cell or tissue derived from plants or animals as parts of plants or animals leading to refusal of cell claims under this ground. Claims related to compositions comprising stem cells are also frequently refused as the compositions are treated as indirectly claiming stem cells. There have been some exceptions though, such as patent number 333231, where a composition comprising stem cells was granted.

A moot issue here is whether cells are actually parts of animals/plants or whether they can be treated as microorganisms. While the Patents Act permits the patentability of microorganisms (that do not occur in nature), the term microorganism has not been defined in either the Act or the manuals that the Patent Office has issued so far. In fact, even the TRIPS agreement which mandates member states to grant patents in relation to microorganisms does not define the term. The European Patent Office recognizes all generally unicellular organisms with dimensions beneath the limits of vision which can be propagated and manipulated in a laboratory. (T 0356/93) as microorganisms.

Since the Patents Act does not limit the scope of the term microorganism and if one were to accept the literary or dictionary meaning of the term microorganism, it would appear that the Patents Act does not prohibit from the scope of patentability cells, which are not visible to the naked eye or which are so small that they require a microscope for viewing.

Moreover, stem cells like induced pluripotent stem cell and human parthenogenetic stem cells, which are somatic cells or oocytes that have been induced to develop the characteristics of unrestrained propagation and ability to develop into any cell type, are markedly distinct from the parent cell from which they are derived and are new cell types altogether. Such cells are indeed creations of man and cannot qualify as an animal part. They are also not living substances that occur in nature and being purely man made fall outside the prohibitory restraint of Section 3(c).

In the absence of judicial precedents and well defined guidelines, the law in India in relation to patentability of stem cell research is at a nascent stage. The Indian Patent Office has been following an unwritten code in the examination of these applications but the approach currently adopted is debatable. It is important to offer robust patent protection to encourage innovation in all fields. While there has been some change in the Patent Offices approach to patentability of stem cells and claims related to methods of producing, culturing and isolation of stem cells, culture media for stem cells, etc., are commonly granted, there is still a lot that can be patented but is currently not. Hopefully, India will see some judicial precedents in the future that will clarify the patentability issues that this field is struggling with.

This article was first published by Legal Era

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Patenting Stem Cell Inventions in India- What to Expect? - Lexology

DBMR has added a new report titled Global Stem Cell Banking Market with data Tables for historical and forecast years represented with Chats & Graphs spread through Pages with easy to understand detailed analysis. this report provides exact information about market trends, industrial changes, and consumer behaviour etc. The report assists in outlining brand awareness, market landscape, possible future issues, industry trends and customer behaviour about industry which eventually leads to advanced business strategies. Being a verified and reliable source of information, this market research report offers a telescopic view of the existing market trends, emerging products, situations and opportunities that drives the business in the right direction of success. The report has been framed with the proper use of tools like SWOT analysis and Porters Five Forces analysis methods.

Global stem cell banking market is set to witness a substantial CAGR of 11.03% in the forecast period of 2019- 2026. The report contains data of the base year 2018 and historic year 2017. The increased market growth can be identified by the increasing procedures of hematopoietic stem cell transplantation (HSCT), emerging technologies for stem cell processing, storage and preservation. Increasing birth rates, awareness of stem cell therapies and higher treatment done viva stem cell technology.

Get Sample Report + All Related Graphs & Charts (with COVID 19 Analysis) @https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-stem-cell-banking-market&pm

Competitive Analysis:

Global stem cell banking market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of inflammatory disease drug delivery market for Global, Europe, North America, Asia-Pacific, South America and Middle East & Africa.

Key Market Competitors:

Few of the major competitors currently working in global inflammatory disease drug delivery market are: NSPERITE N.V, Caladrius, ViaCord, CBR Systems, Inc, SMART CELLS PLUS, LifeCell International, Global Cord Blood Corporation, Cryo-Cell International, Inc., StemCyte India Therapeutics Pvt. Ltd, Cordvida, ViaCord, Cryoviva India, Vita34 AG, CryoHoldco, PromoCell GmbH, Celgene Corporation, BIOTIME, Inc., BrainStorm Cell Therapeutics and others

Market Definition:Global Stem Cell Banking Market

Stem cells are cells which have self-renewing abilities and segregation into numerous cell lineages. Stem cells are found in all human beings from an early stage to the end stage. The stem cell banking process includes the storage of stem cells from different sources and they are being used for research and clinical purposes. The goal of stem cell banking is that if any persons tissue is badly damaged the stem cell therapy is the cure for that. Skin transplants, brain cell transplantations are some of the treatments which are cured by stem cell technique.

Cord Stem Cell Banking MarketDevelopment and Acquisitions in 2019

In September 2019, a notable acquisition was witnessed between CBR and Natera. This merger will develop the new chances of growth in the cord stem blood banking by empowering the Nateras Evercord branch for storing and preserving cord blood. The advancement will focus upon research and development of the therapeutic outcomes, biogenetics experiment, and their commercialization among the global pharma and health sector.

Cord Stem Cell Banking MarketScope

Cord Stem Cell Banking Marketis segmented on the basis of countries into U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

All country based analysis of the cord stem cell banking marketis further analyzed based on maximum granularity into further segmentation. On the basis of storage type, the market is segmented into private banking, public banking. On the basis of product type, the market is bifurcated into cord blood, cord blood & cord tissue. On the basis of services type, the market is segmented into collection & transportation, processing, analysis, storage. On the basis of source, market is bifurcated into umbilical cord blood, bone marrow, peripheral blood stem, menstrual blood. On the basis of indication, the market is fragmented into cerebral palsy, thalassemia, leukemia, diabetes, autism.

Cord stem cell trading is nothing but the banking of the vinculum plasma cell enclosed in the placenta and umbilical muscle of an infant. This ligament plasma comprises the stem blocks which can be employed in the forthcoming time to tackle illnesses such as autoimmune diseases, leukemia, inherited metabolic disorders, and thalassemia and many others.

Market Drivers

Increasing rate of diseases such as cancers, skin diseases and othersPublic awareness associated to the therapeutic prospective of stem cellsGrowing number of hematopoietic stem cell transplantations (HSCTs)Increasing birth rate worldwide

Market Restraint

High operating cost for the therapy is one reason which hinders the marketIntense competition among the stem cell companiesSometimes the changes are made from government such as legal regulations

Key Pointers Covered in the Cord Stem CellBanking MarketIndustry Trends and Forecast to 2026

Market SizeMarket New Sales VolumesMarket Replacement Sales VolumesMarket Installed BaseMarket By BrandsMarket Procedure VolumesMarket Product Price AnalysisMarket Healthcare OutcomesMarket Cost of Care AnalysisMarket Regulatory Framework and ChangesMarket Prices and Reimbursement AnalysisMarket Shares in Different RegionsRecent Developments for Market CompetitorsMarket Upcoming ApplicationsMarket Innovators Study

Key Developments in the Market:

In August, 2019, Bayer bought BlueRock for USD 600 million to become the leader in stem cell therapies. Bayer is paying USD 600 million for getting full control of cell therapy developer BlueRock Therapeutics, promising new medical area to revive its drug development pipeline and evolving engineered cell therapies in the fields of immunology, cardiology and neurology, using a registered induced pluripotent stem cell (iPSC) platform.In August 2018, LifeCell acquired Fetomed Laboratories, a provider of clinical diagnostics services. The acquisition is for enhancement in mother & baby diagnostic services that strongly complements stem cell banking business. This acquisition was funded by the internal accruals which is aimed to be the Indias largest mother & baby preventive healthcare organization.

For More Insights Get FREE Detailed TOC @https://www.databridgemarketresearch.com/toc/?dbmr=global-stem-cell-banking-market&pm

Research objectives

To perceive the most influencing pivoting and hindering forces in Cord Stem Cell Banking Market and its footprint in the international market.Learn about the market policies that are being endorsed by ruling respective organizations.To gain a perceptive survey of the market and have an extensive interpretation of the Cord Stem Cell Banking Market and its materialistic landscape.To understand the structure of Cord Stem Cell Banking Market by identifying its various sub segments.Focuses on the key global Cord Stem Cell Banking Market players, to define, describe and analyze the sales volume, value, market share, market competition landscape, SWOT analysis and development plans in next few years.To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market.To share detailed information about the key factors influencing the growth of the market (growth potential, opportunities, drivers, industry-specific challenges and risks).To project the consumption of Cord Stem Cell Banking Market submarkets, with respect to key regions (along with their respective key countries).To strategically profile the key players and comprehensively analyze their growth strategiesTo analyze the Cord Stem Cell Banking Market with respect to individual growth trends, future prospects, and their contribution to the total market.

Customization of the Report:

All segmentation provided above in this report is represented at country levelAll products covered in the market, product volume and average selling prices will be included as customizable options which may incur no or minimal additional cost (depends on customization)

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Global Stem Cell Banking Market Is Projected To Witness Vigorous Expansion By 2026 - Kewaskum Statesman News Journal

In 2007, a group of researchers reported a startling discovery: They had created sperm-like cells out of stem cells taken from the bone marrow of human men. Two years later, however, the study was retracted due to charges of plagiarism. Thirteen years later, the ability to create functional human sperm out of stem cells remains elusive.

Scientists have been trying to figure out how to create functioning human gametes eggs and sperm from stem cells for 20 or 30 years, says Vittorio Sebastiano, a stem cell biologist at Stanford University whose research focuses on reproductive biology. Doing so would help people struggling with infertility have children and help scientists unlock the secrets of human development. Since 2007, scientists have made considerable progress on this front, creating healthy mouse pups from stem cell-generated gametes and even immature human egg cells. But there is still a long road ahead before scientists will be able to convert skin or bone marrow into babies.

We are trying to really find ways to efficiently, robustly generate germ cells that can be, in the short term, used to understand the biology of these concepts, but in the long term [used to be] able to restore fertility, says Sebastiano.

When the first baby conceived via in vitro fertilization (IVF) was born in 1978, it was a major step forward for reproductive science and a precursor to the stem cell research conducted by Sebastiano and others today, he says. But IVF is not an option for every individual or couple trying to have a biological child, including those who are born without gametes or who receive aggressive cancer treatments at a young age. This scientific technique would offer these individuals a new shot at reproduction.

The next major step came in the 2000s, with the creation of induced pluripotent stem cells (iPSCs). These cells are taken from blood or skin cells and reprogrammed to behave like embryonic cells, which have the ability to develop into any type of cell in the body. Since then, researchers have been trying to figure out how to turn these embryonic-like cells into functional sperm and eggs.

A colony of induced pluripotent stem cells used to treat the rare genetic disorder Fanconi anemia. (Credit: Juan Carlos Izpisua Belmonte, Salk Institute for Biological Studies)

Part of what has made this work so challenging is that scientists havent been able to fully grasp what happens in a human embryo during normal development, says Sebastiano. Scientists understand this process in mice because the rodents are easy to study in the lab. But ethical restrictions and technical factors (like having access to the embryos at just the right point in time) make this phenomenon hard to study in people, he says.

Despite the roadblocks, scientists have made significant progress in the last 10 years. In 2012, a group of researchers in Japan created fertile mouse eggs from iPSCs and used those eggs to breed healthy mouse pups. In [the] mouse, the whole circle has already been completed, says Sebastiano. Now it has been shown by a couple of groups in the UK and in Japan that you can generate embryonic-like cells from mice and then you can actually push these cells to become eggs or sperm, fully functional.

In 2018, the same group of Japanese scientists made another major breakthrough. Using human blood cells and the pluripotent stem cell technique, they managed to produce immature human eggs.

Similar efforts to create sperm are not as far along, says Sebastiano. Several efforts over the years have purported to create sperm-like cells, including the 2007 blood marrow study. A much-heralded study published in 2014 also made major news, but Sebastiano says the development of the cells in that study didnt go far beyond the earliest stages of differentiation.

But, we are actively working on it, says Sebastiano. Probably in the next few years we will be able to generate fully functional sperm and fully functional oocytes. Then, the question will be how do scientists test the quality of these gametes, he says.

The only way to fully assess the quality and functionality of a sperm or egg is to use it to, well, try to fertilize another gamete and produce a baby. Thats why this work has to be approached with the utmost care, says Sebastiano. He hypothesizes that once scientists have developed techniques that they think produce mature human oocytes and sperm, the next step will be testing these techniques in primates. That way, researchers can follow the entire life of individual animals produced from this technique to see if any unexpected problems develop, he says.

Sebastiano has no doubt that one day, these stem cells could help individuals struggling with infertility to produce healthy children. This, along with a fascination with biological development, is what drives Sebastianos work. There are also, of course, significant ethical considerations that have to be carefully considered. This technique has the potential to affect human life on a generational level, he notes. And many people also raise concerns about other future consequences, like the ability to create designer babies or produce offspring from hairs stolen from unsuspecting celebrities. Bioethics experts have written about the need to start working through the medical and legal issues around this technique now, before it is viable.

There is a need actually to develop this, but since we are really dealing with a very unique cell type we need to be cautious, says Sebastiano.

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How Close Are We To Making Babies from Bone Marrow? - Discover Magazine

By Sh. Heera Lal

Indias blood shortage crisis is no alien to headlines. Now with a corona virus fear, blood banks in the country are going to face even tougher times ahead. Despite the massive burden of trauma and surgeries in the current situation, several hospitals in almost all states and union territories have been struggling to meet the daily requirements of blood in the past few weeks.

This disruption has impacted availability of blood for emergency surgeries, postpartum hemorrhage cases, thalassemia, sickle-cell disease, and cancer patients.

In India, blood donations have dramatically reduced due to the implementation of social distancing, cancellation of various blood drives and low donor turnout due to fears associated with catching infection from public places such as hospitals and blood banks.

The government needs to build more awareness on the compliance of safety protocols being followed by all blood banks and collection centres to instill confidence in public on voluntary blood donation in these uncertain times. In addition, support needs to be extended for easy as well as safe movement of donors and supply chain of critical materials and equipment used in blood and component collection.

The National Blood Transfusion Councils (NBTC) interim guidelines issued on 25 March 2020, emphasizes on continuity of supply of safe blood and recommends resuming both outdoor and in-house donation, in compliance with social distancing standards, biomedical-waste disposal rules and infection control guidelines. Guidelines state that people are at no risk of developing COVID-19 through the blood transfusion or via a blood donation procedure.

The lockdowns this year have restricted movement of people, so regular donors living far from a hospital or blood bank are unable to donate and finding new donors in nearby areas has become a huge challenge. All though people are afraid of attending camps and blood centers due to COVID-19, even then many donors are coming forward to save the life of those who need blood every month to survive.

Need of blood has also raised and this is a tough time when we have to weigh between the need of blood and fear of CORONA. Public is learning to live with CORONA, taking precautions, should also start voluntary donation as this is the need of time. This will require strong IEC.

Presently, Indias blood transfusion system (BTS) is extremely uneven, with almost no interlinkages. In absence of interaction and connectivity between blood banks, there is ineffective supervision of demand as well as supply in terms of accessibility and value of blood. Most of these issues in Indian blood system preexist due to low significance given to blood in our healthcare system, absence of a regulatory structure and insufficient financing in the BTS related infrastructure, although we already have a National Blood Policy of 2002, a devoted national blood legislation, which is completely absent.

Availability, Affordability, and Safety are the pillars that we need to make Indias blood system effective. In order to address these pillars and as suggested by World Health Organization (WHO), it is imperative for all actions related to blood collection, testing, processing, storage and distribution to be synchronized at a national level.

Indias massive trauma and surgical burden, high occurrence of blood disorders and communicable diseases linked with excessive Postpartum Hemorrhage (PPH) related deaths, imply that a well-operating blood system is the need of the hour and should be a top priority of our healthcare policy.

The timely availability of safe and quality blood is often a decisive factor in saving human life. An insufficient or unsafe blood supply for transfusion has a negative impact on the effectiveness of key health services and programs to provide appropriate patient care in numerous acute and chronic conditions.

In spite of the fact that Dos and Donts needed are sent to blood banks and donor organizers to make sure that donors and staff remain safe, due to fear of corona virus, people are not coming to blood banks or holding camps to donate blood.

Also due to restrictions of movement through the government besides the donors even the staff finds it difficult to reach the workplace. There is a need to provide special transport for donors and staff. The supplies of consumables and reagents required for collection and testing of blood are likely to face shortages if transport is not easily available.

The value of blood in any healthcare system cannot be weakened. To preserve India from the worldwide surgery blood drought, it is imperative for blood sufficiency, safety, and sustainability to become sacrosanct in Indias healthcare system.

The author is Additional Mission Director at National Health Mission, Uttar Pradesh.

DISCLAIMER: The views expressed are solely of the author and ETHealthworld.com does not necessarily subscribe to it. ETHealthworld.com shall not be responsible for any damage caused to any person/organisation directly or indirectly.

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India could bleed itself dry amidst covid-19 crisis owing to blood shortage - ETHealthworld.com

The federal government may continue to pay for controversial human embryonic stem cell research, a federal appeals court ruled Friday.

The three-judge panel says the government has correctly interpreted a law that bans the use of federal funds to destroy human embryos for research. The ruling is unlikely to put the issue to rest and one of the judges pleaded for Congress to make clear what the government should and should not be able to do.

The hard-to-understand case pits science against mostly religious arguments against using embryos in medical research. It's even more confusing because there are so many differenlt types of cells called stem cells.

Dr. James Sherley of Boston Biomedical Research Institute and Theresa Deisher of AVM Biotechnology in Seattle, who both do research using adult stem cells and oppose the use of human embryonic stem cells, sued in 2009. They said federal guidelines violate the law and would harm their work by increasing competition for limited federal funding.

Its been back and forth in the federal courts since then, and Sherley has vowed to take the case all the way to the Supreme Court.

The embryonic stem cells at issue are the bodys master cells. Found in days-old embryos, they are the source of all the cells and tissues in the body blood, brain, bone and muscle. Researchers are studying them to investigate how disease develops and are using some as transplants to treat diseases from Parkinsons to cancer. They are being tested in people to repair spinal cord injuries and as a possible cure for some forms of blindness.

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Opponents of the research say its unacceptable to destroy a human embryo to get the cells. The 1996 Dickey-Wicker amendment, added by Congress to budget language every year, forbids the use offederal funds in research that destroys embryos.

When he was president, George W. Bush decided that the ban extended to human embryonic stem-cell research and greatly limited the federal program.

As one of his first acts after he entered office, President Barack Obama issued an executive order reversing this and encouraging the National Institutes of Health to pay for embryonic stem-cell research, so long as federal money wasnt used to directly make the stem cells. To get the cells, someone in a private lab using private money has to take apart the embryos usually left over from fertility clinics and destined for the trash can. Federal funds may be used to work with the cells that private labs make available.

On Friday, Judge Janice Rogers Brown, Judge David Bryan Sentelle, and Karen LeCraft Henderson of the U.S. Court of Appeals in Washington upheld an earlier court ruling throwing out the case. The law, they said permits federal funding of research projects that utilize already-derived embryonic stem cellswhich are not themselves embryosbecause no human embryo or embryos are destroyed in such projects.

As we have held before, the NIH interpretation of the statutes actual language is reasonable, they added.

"NIH will continue to move forward, conducting and funding research in this very promising area of science. The ruling affirms our commitment to the patients afflicted by diseases that may one day be treatable using the results of this research," NIH director Dr. Francis Collins said in a statement.

But Judge Brown wasnt entirely happy and asked Congress to please clear up the unclear wording of the Dickey-Wicker amendment and saying there are aspects of this case that should trouble the heart.

Given the weighty interests at stake in this encounter between science and ethics, relying on an increasingly Delphic, decade-old single paragraph rider on an appropriations bill hardly seems adequate, she wrote in Fridays opinion.

Supporters of the research said they were thrilled. This ensures that Americas best scientists can continue to move this work forward despite ideologically driven attempts to derail it, said Amy Rick, president of the Coalition for the Advancement of Medical Research.

There are other types of stem cells, including so-called adult stem cells, found in everyone's bodies. But scientists say they don't have the same powerful properties as embryonic stem cells. Labs are also working to re-program ordinary cells to behave like embryonic cells. A deeply divided Congress has decided not to weigh in on the issue until elections give one party or the other more power.

Maggie Fox, Senior Writer and Maggie Fox, Senior Writer

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Court rules controversial stem cell research is legal

Legal Issues in Stem Cell Therapy in the U.S.Jul 30, 2019 | Fred Greguras

My wife has had osteoarthritis, sometimes called wear-and-tear arthritis, in both of her knees since 2011. She first saw an advertisement for stem cell treatment in 2012 and continued to do research on the treatment. Late in 2018, after ultrasounds on her knees and consultation with several doctors and clinics in California and Colorado, she decided to have stem cell therapy that could regenerate the meniscus cartilage of her knees. Such therapy is a minimally invasive procedure that has the potential to slow the progress of the arthritic damage, repair joint cartilage and avoid or delay invasive knee replacement surgery. Such therapy can help the body repair itself naturally.

We thought it was best to act now before her knees worsened since the earlier the stem cell treatment began, the greater the chances for a successful outcome there would be. The present lack of health insurance coverage was considered, but the treatment cost was reasonable given the potential to avoid more invasive surgery and the timing of treatment. Most insurance plans, including Medicare, define the procedure as experimental and investigational and do not cover the therapy.

Based on her research, my wife selected Dr. Jason Glowney of Boulder Biologics to perform the treatment. Her treatment took place in the second week of January, 2019, as an outpatient at a hospital in Boulder, Colorado. The procedure was completed in under four hours. She was injected with her own stem cells (called an autologous donation), reducing the risk of immune rejection and other complications.

The medical team used ultrasound to identify the best sites for injection into the damaged tissue of her knees. The same needle remained in each knee site during the treatment, but the injections in each step described below were all done with separate syringes in sequence. There was no mixture of any of the multiple components in a single syringe.

The doctor gave her light oral sedation to help her relax for the procedure and used local anesthetic at the points of cell harvest and injection. No general anesthetic was administered. The procedure began with a harvest of platelet-rich plasma (PRP) from her blood. Her blood was quickly processed through a centrifuge to separate the blood and concentrate the platelets in the plasma, which was then injected to fertilize the knee sites to enhance cell growth. The concentrated platelets contain growth factors along with bioactive proteins that help initiate and stimulate tissue repair and regeneration. (In late May, 2019, she had another PRP injection to stimulate and enhance the growth of the stem cells.)

The next step in the procedure was to harvest her bone marrow, centrifuge it into an injectable volume of aspirate concentrate and then inject the concentrate in both knees. The bone marrow aspirate contains stem cells that can help regenerate bone and cartilage.

The adipose (fat-derived) stem cells used in the next step compliment the bone marrow stem cells. The adipose cells were harvested by a minimally invasive liposuction procedure, centrifuged to isolate the cells and then injected in both knees. The fat on our bodies can be a rich source of stem cells.

Hundreds of thousands of cells were harvested and injected in each step in order to have an adequate number of stem cells for the treatment. The stem cells decide whether to differentiate into bone, meniscus or other cartilage or to simply renew.

My wife was given antibiotic (doxycycline) tablets to take at the end of the procedure and, for a period thereafter, to assist the differentiation process and to help decrease cartilage degradation.

As discussed in more detail below, the doctors procedure was designed to involve only simple human cellular and tissue products from the same patient and not to be a new biological product or drug which requires FDA approval. The procedure would be a new biological product or drug requiring FDA approval if there had been more than minimal manipulation of each component part. Even a mixture of a patients own stem cells and an antibiotic administered from the same syringe would be deemed a new biological product or drug by the FDA.

The doctor gave my wife guidelines for physical activity and medications during the post-injection period. The guidelines were designed to promote the growth of the stem cells to regenerate tissue. The cells are fragile, and she had to be careful not to cause too much stress or shearing on them which could impede growth. Her pain was intense during the first 24 hours, and she stayed in bed much of the time. She used a walker for about the first week. She started physical therapy about six days after the injections with the doctors approval. The doctor recommended that she not take any anti-inflammatory medications (like ibuprofen or motrin), for six weeks since they could impede the differentiation of the stem cells. The doctor advised her that most patients dont feel any knee improvement for at least three weeks and possibly for up to six to eight weeks. If there is no improvement by the six-month point after the injections, then the therapy has not worked.

A self-reporting instrument is used for assessing a patients knee status. The 33 items measured are intended to represent all major indicators of knee status. My wifes measures are all very positive at this six-month point after the procedure. The measurement factors include: (1) knee symptoms such as knee swelling, stiffness and frequency of pain; (2) amount of pain in activities such as walking, standing and going up and down stairs; and (3) degree of difficulty in activities such as walking, bending down and going up and down stairs. Each item is rated on a five-point scale relating to the extent of its occurrence or severity during the past week.

Stem Cell Background

Stem cells are different from other cell types in our bodies because they are capable of renewing (copying) themselves through cell division, sometimes after long periods of inactivity. Stem cells also have the potential to differentiate into other cell types in our body. When a stem cell divides, each new cell has the potential either to remain a stem cell or to differentiate into more specialized cells that form the bodys tissues and organs. In some organs, stem cells regularly divide to repair and replace worn out or damaged tissues. In other organs, stem cells only divide under special conditions.

There are several types of stem cells that are formed at different times in our lives or come from different places in our body. Embryonic stem cells (ESCs) exist in the embryo only at the earliest stages of human development. ESCs are pluripotent, meaning they have the potential to differentiate into almost all cell types in the body. There are social and ethical issues relating to the use of ESCs, since harvesting the cells causes the destruction of an embryo. Many countries, including the U.S., have government-imposed restrictions on either ESC research or the production of new ESC lines.

Somatic or adult non-embryonic tissue-specific stem cells (ASCs) exist in specific tissues throughout the body after early human development. The stem cells injected into my wifes knees were ASCs. ASCs are multipotent, meaning they can differentiate into more than one type of specialized cell of the body, but not all types. ASCs are generally limited to differentiating into cell types of their tissue of origin, which can help with the replacement of cells from damaged tissue. ASCs can be an autologous stem cell donation, which is less likely to be rejected.

Amniotic stem cells (AMSCs) exist in the amniotic sac, which surrounds a baby in the uterus and remains until the babys birth. AMSCs are harvested right after the mother gives birth, without harming the baby. Some clinics make exaggerated claims about the therapeutic potential of ASMCs. AMSCs, however, are also multipotent, and the tissues they can differentiate into are substantially the same as stem cells from adipose (fat) and bone marrow. AMSCs exist only for a limited time, but adipose and bone marrow ASCs continue to be produced throughout our lives and can be harvested from the patient seeking therapy.

Some tissues and organs contain small amounts of ASCs whose function is to replace cells from that same tissue that deteriorate over time or are damaged by injury. For example, blood-forming stem cells in bone marrow can differentiate into red blood cells, white blood cells and platelets. However, blood-forming stem cells dont generate liver or lung or brain cells, and stem cells in other tissues and organs dont generate red or white blood cells or platelets.

Pluripotent stem cells have great therapeutic potential but still have major technical issues. Scientists cant control their differentiation into the many types of cells in the body which can result in unwanted tissue such as tumors. Since such stem cells are not from the recipient, they may also lack the compatibility needed to prevent rejection by the immune system.

Over 10 years ago, researchers identified conditions that enabled some specialized ASCs to be reprogrammed genetically back to an ESC-like state. The reprogrammed cells function similarly to ESCs and are called induced pluripotent stem cells (iPSCs). The iPSCs function similarly to ESCs, with the ability to differentiate into almost any cell of the body and to create an unlimited source of cells. iPSCs may ultimately help address the ethical concerns of ESCs and provide new potential for therapy, but there are still technical issues including whether they are actually equivalent to ESCs and the capability to control the differentiation process.

Legal Issues

FDA Approval Requirements

While the U.S. Food and Drug Administration (FDA) moves agonizingly slowly, its priority is human safety which is not the case in many other countries. Some other countries are the Wild West of stem cell therapy and have become medical tourism destinations for high-risk stem cell treatment. The FDA recommends that stem cell therapy is either FDA-approved or is done pursuant to an Investigational New Drug Application (IND), a clinical investigation plan submitted to and permitted to proceed by the FDA. There are many active clinical trials investigating the potential of ASCs listed on the U.S. National Institutes of Healths website.[1] Stem cell products approved by the FDA are listed on its web site.[2] There is no FDA-approved therapy involving the transplantation of ESCs. ESCs must be not be added to an injection, such as PRP, before it goes into a human.

The FDA regulates human tissues intended for transplant under 21 C.F.R. Part 1271: Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps). Cellular and tissue-based therapies are regulated by the Office of Cellular, Tissue and Gene Therapies within the FDA Center for Biologics Evaluation. There are two primary regulatory pathways for these products. Cellular therapy products that meet all the criteria in 21 CFR 1271.10(a) are regulated solely as HCT/Ps and are not required to be licensed, approved or cleared by the FDA. These products are often referred to as 361 products because they are regulated solely under Section 361 of the Public Health Service Act (PHSA).[3] The regulatory purpose for such products is to prevent the introduction, transmission and spread of communicable diseases.

If a cellular therapy product does not meet all the criteria in 21 CFR 1271.10(a), it is regulated as a drug, device and/or biological product under the Federal Food, Drug and Cosmetic Act (FDCA)[4] and Section 351 of the PHSA (a 351 product). The FDA requires premarket approval for such a product. The criteria that determine whether a product is a Section 361 HCT/P or a Section 351 biological product include, primarily, whether a product has been minimally manipulated and is intended for homologous use. Stem cell therapies generally do not satisfy these criteria and therefore are usually regulated as Section 351 products.

In the 2014 decision, United States of America v. Regenerative Sciences, LLC,[5] the court held that a mixture of autologous ASCs and other components was a 351 product and subject to FDA approval. Regenerative Sciences, LLC argued that its process did not create a mixture but only expanded the patients own cells and, therefore, was a simple 361 product which does not require FDA approval. The FDAs position is that any process involving human cellular and tissue products that includes culturing, expansion and added growth components or antibiotics requires FDA approval as a biological product or new drug because the process constitutes significant manipulation.

The FDA alleged that the product was a 351 product for failure to comply with its minimal manipulation provisions and because the resulting stem cells were not intended for homologous use. Homologous use means that a human cellular or tissue product is used clinically in a manner that is essentially the same as the natural function. The homologous use definition is strictly interpreted by the FDA, so that most innovative ways to use stem cells to potentially treat patients would be through non-homologous usage. The FDA will generally define even modestly different uses as non-homologous.

There are many clinics offering stem cell therapy in the U.S., some which carefully follow the law and others which do not. The FDA has only has brought a small number of enforcement actions because of resource limitations and proof concerns. Enforcement usually occurs in high-profile situations where a patient has died or is severely harmed.

Intellectual Property Issues

The two important types of intellectual property protection relating to stem cell therapy are trade secret and patent protection. For example, the cell harvesting techniques and settings for the centrifuge processing in each step in my wifes treatment can be protected as trade secret know-how. The culturing and cocktails of growth factors and/or other components in the Regenerative Sciences, LLC case are another example.

There are many patents registered with the USPTO that contain the term stem cell, but recently, many human stem-based inventions have been rejected for not being eligible patentable subject matter. Patent-eligible subject matter is defined in 35 U.S.C. Section 101 as: Whoever invents or discovers any new and useful process, machine, manufacture or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. There are three exceptions to subject matter eligibility: laws of nature, physical phenomena and abstract ideas.[6] The laws of nature exception has been the basis for rejection of patent eligibility for certain stem cell-related inventions.

There were two important court decisions in 1977 and 1980 relating to patent protection eligibility for the biotechnology industry.[7] The USPTO issued many stem cell patents following these decisions.

Several Supreme Court decisions in the past 10 years, however, have narrowed the scope of patent-eligible subject matter under Section 101.[8] In the Mayo decision, the Court held the invention was not patentable, stating that it effectively claimed the underlying laws of nature. The Court held that a claim that encompasses the use of a natural law must also include additional elements, sometimes referred to as an inventive concept, sufficient to ensure that the patent amounts to significantly more than a patent upon the natural law itself.

The scope of patent-eligible subject matter was further narrowed in the Myriad decision, which held that a naturally occurring DNA segment is a product of nature and not eligible for patent protection merely because it had been isolated. The Court looked for markedly different characteristics from any found in nature of the isolated gene to determine patent eligibility. The changes resulting from isolation of a gene sequence were considered incidental and not enough to make the isolated gene markedly different.

Three recent decisions in the Federal Circuit indicate that method-of-treatment claims that may involve a law of nature are patent-eligible.[9] Each of the patents required an affirmative treatment step. The decisions seem to hold that a patent directed to detecting a condition in a patient is not Section 101-eligible under Mayo, while a patent directed to using that detection to change some aspect of the patient is eligible. The patent may have been based upon the inventors discovery of a law of nature but the patent did not simply claim that law of nature. Rather, it was directed to a specific method of treatment.

The United States Patent and Trademark Office (USPTO) has published guidelines for patent examiners on how to analyze a claim which includes a nature-based product for patent eligibility.[10] Claims are to be examined for an inventiveness that has markedly different characteristics from naturally occurring products. Patent eligibility for a natural product is to be determined primarily by whether the claimed product possesses any structural, functional and/or other properties that represent markedly different characteristics from the natural counterpart. If the claim includes a nature-based product that has markedly different characteristics, then the claim is not within the product of nature exception. On the other hand, if the claim includes a nature-based product that does not have markedly different characteristics from its naturally occurring counterpart in its natural state, then the claim is within the product of nature exception and is not eligible for patent protection.[11]

The first step in the analysis is to select the counterpart(s) to compare to the nature-based product. The second step is to identify characteristics to compare, since the analysis is based on comparing the characteristics of the claimed nature-based product and its counterpart. Characteristics can be expressed as the nature-based products structure, function and/or other properties, and are evaluated on a case-by-case basis. The final step is to compare the characteristics of the claimed nature-based product to the characteristics of its naturally occurring counterpart in its natural state to determine if the characteristics of the claimed product are markedly different. If there is a change in at least one characteristic resulting from, or produced by, the patent applicants efforts or influences, then the change will generally be found to be a markedly different characteristic.

Consumer Protection

My wife was provided with disclosures from the doctors office and requested to sign a number of consents and waivers as a condition of receiving therapy. One of the waivers was a no assurance of successful treatment agreement.

State laws protecting consumers against deceptive advertising are applicable to representations about the effectiveness of stem cell treatment. Several state legislatures have debated additional protections for consumers relating to such treatment. California enacted a consumer protection law in late 2017 that requires clinics offering stem cell treatments to disclose if the treatment is not approved by the FDA.

The Federal Trade Commission (FTC) and FDA are pursuing enforcement actions in selected cases that may cause stem cell clinics to be more careful about their representations and activity. In late 2018, the FTC settled charges with a California-based physician and his businesses of deceptively advertising that amniotic stem cell therapy can treat serious diseases.[12] The settlement prohibits the defendants from making any health claims in the future unless the claims are true and supported by competent and reliable scientific evidence. This was the first enforcement action brought by the FTC against a stem cell clinic.

In early June, 2019, a federal judge granted the FDA an injunction to prevent the U.S. Stem Cell Clinic (based in Florida) from offering treatments using adipose stem cells injected into the spinal cords of patients to treat Parkinsons disease, chronic obstructive pulmonary disease and other serious conditions.[13] The court held that the defendants misbranded the possible therapeutic effects. The court also determined the clinic failed to prevent microbiological contamination of products which put patients at risk for infections.

Conclusion

As indicated, the status measures for my wifes knees are all very positive six months after the procedure. She is glad she tried it. I would try the therapy if I have problems with my knees.

The FDA will continue to move slowly to approve stem cell therapies since its priority is human safety. Some other countries have become medical tourism destinations for high-risk stem cell treatment. Many of the claims of such foreign clinics and of some clinics in the U.S. are medically unproven. The FDA and other regulators will continue to bring enforcement actions based on the severity of patient risk and available resources. Obtaining patent protection for stem cell-related inventions is challenging because of the subject matter eligibility issue under Section 101. The recent method-of-treatment decisions in the Federal Circuit may provide a helpful eligibility precedent for some inventions.

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Legal Issues in Stem Cell Therapy in the U.S. - Inventus Law