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Archive for the ‘Stem Cell Therapy’ Category

Stem Cell Therapy Market – Worldwide Industry Scope, Size …

Monday, April 10th, 2017

Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

The study presents reliable qualitative and quantitative insights into:

The regional analysis covers:

The vast market research data included in the study is the result of extensive primary and secondary research activities. Surveys, personal interviews, and inputs from industry experts form the crux of primary research activities and data collected from trade journals, industry databases, and reputable paid sources form the basis of secondary research. The report also includes a detailed qualitative and quantitative analysis of the market, with the help of information collected from market participants operating across key sectors of the market value chain. A separate analysis of macro- and micro-economic aspects, regulations, and trends influencing the overall development of the market is also included in the report.

Highlights of the report:

Note: Immense care has been taken to present data with the highest levels of accuracy in all TMRResearch reports. Nevertheless, recent developments related to market/vendor landscape may take time to reflect in the analysis.

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Stem Cell Therapy | Stem Cell Treatments | Idaho Falls …

Monday, April 10th, 2017

Chronic pain is a problem that sadly affects most people within their lifetime. There are patients who fall into the category of not responding to noninvasive therapies but they decline or are not candidates for joint or spine surgery. Some clinicians are turning to autologous stem cell therapy and they are seeing benefits.

Evidence of the effectiveness of the pain relief seen by the therapy have been reported to be at least 50% in relative consistency in some correlational studies, meaning the treatments may be working fairly well for a number of patients. A significant number of results have been seen in patients as much as 3 years after the procedure is performed, meaning that recuperation is highly likely for all types of pain and injuries.

Promising application of stem cell therapy resides within the treatment of degenerative disc disorder, which affects millions of people within the United States. In 2015, Pettine, Murphy, Suzuki et al. found that by using autologous stem cells to treat discogenic low back pain, they were able to improve pain scores in 21 of 26 patients within their study. Rehydration of the discs in eight of twenty patients according to MRI in conjunction with sustained pain relief through 12 months represents promise for the use of this regenerative medicine approach (Pettine, Murphy, Suzuki et al, 2014). Results such as these are promising and are currently encouraging larger clinical trials in order to generalize results across a very extensive breadth of patients.

Teton Spine and Sports Pain Center utilizes stem cells for the treatment of:

Repeat treatment can be initiated after 6 months for optimal results for patients with severe symptoms.

Stem cells have been clinically and scientifically proven to effectively treat chronic and acute pain. Stem cells are the bodys master cells. They are undifferentiated cells that have the ability to transform into a variety of different cells, replace dying cells, and regenerate damaged tissue. Stem cells are derived from your own bodys bone marrow or fat deposit (adipose).

An alternative method for regenerative medicine is through allograft tissues (from a purified amniotic source). These tissues have a high concentration of collagens, structural proteins and growth factors that support healing. This immune-privileged tissue can have some advantages over other regenerative therapies. Speak with our physician about which regenerative medicine technique would be right for you and your injury.

Stem cell therapy is a very simple and safe outpatient procedure that is performed by a qualified physician. Its easy as 1, 2, 3!

Removal of bone marrow or fat tissue. If you choose to use amniotic stem cells, half the battle is already over.

Once a sample of your bone marrow or fat tissue has been obtained, the cells are isolated with a specialized centrifuge. If you decide to use amniotic stem cells, they are delivered to the doctors office ready for injection.

The stem cells are then carefully injected into the site where the injury exists and the healing and regeneration begins!

Two advantages of a stem cell injection over surgery are:

Most patients find themselves back in their daily routine the day after the procedure. Healing gradually happens over the course of 2-6 weeks and can continue for up to 12+ months.

If you havent already learned all the wonderful benefits of stem cell therapy, here they are listed out for you:

Stem cell therapy procedures can treat the following conditions (but not limited to):

If you don't see your condition, please contact us. You may still be a candidate for stem cell therapy.

Stem cells are harvested and concentrated from amniotic fluid, bone marrow, or fat to be re-injected directly into damaged or degenerated tissues. This procedure is performed on the same day for the patients convenience and stem cells are minimally altered so as to advance the healing process for each patient. Since cells are obtained from the patient and returned to the patient within a single surgical procedure in most procedures, there are no issues with immune rejection or increased risk of infection.

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Stem Cell Therapy for Autism Shows Promise – WebMD

Friday, April 7th, 2017

April 6, 2017 -- A stem cell treatment for autism shows promise, according to a new study, but the investigators and other experts emphasize that the therapy is still in the early stages and much more research is needed.

The Duke University study included 25 children, ages 2-6, with autism and assessed whether a transfusion of the youngsters' own umbilical cord blood containing rare stem cells would help treat their autism, CNN reported.

Behavioral improvements were reported in 70 percent of the patients, according to the study in the journal Stem Cells.

A second, larger trial is now underway and the researchers hope they will find a long-term treatment for autism, CNN reported.

Some experts say many unanswered questions remain and the study authors agree much more work needs to be done. This initial trial was a safety study, meaning doctors and the children's families knew the therapy was being administered and there was no comparison between treated and non-treated children.

"Some children, who were not speaking very much, had big increases in their vocabulary and their functional speech," study author Dr. Joanne Kurtzberg, head of the Robertson Clinical and Translational Cell Therapy Program, told CNN.

"Many children were able to attend to play and have meaningful communication in a way that they weren't before. Some children had less repetitive behaviors than they did when they came onto the study," Kurtzberg said.

"The study was very encouraging. We did see positive results. However, it did not have a comparison group, which is very important in establishing whether a treatment is actually effective," study author Dr. Geraldine Dawson, director of the Duke Center for Autism and Brain Development, told CNN.

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Island Animal Hospital Offers Stem Cell Therapy – Beachside Resident

Thursday, April 6th, 2017

No one wants surgery. Dr. Jeffrey Christianson is participating in a study that may provide relief for injured or immune-disordered pets without incisions.

Stem cells can morph into any type of cell needed. The cells are harvested from the animals fat, processed, and reinjected into the pet. These one-size-fits-all cells can be used to replace joint tissue, bone, or other tissues that have worn away or become injured.

Stem cell therapy is a branch of Restorative Medicine helping sick animals restore and improve function. Veterinary medicine has been utilizing Autologous (stem cells from the pet) therapy for well over a decade. It helps animals with arthritis, injuries, inflammatory bowel disease, and other immune-mediated disorders rehabilitate or regain some function.

Dr. Christiansons newest project is a research study to analyze the use of Allogeneic cells (cells from donor pets) in therapy. The clinic is taking part in a double-blinded placebo controlled research study. Half of the patients just get a saline control solution injected into the joint as opposed to a stem cell therapy. He will monitor the results over a six-month period. He wont know until the end of the study who got the control. Some of the pets get a stem cell treatment for free. We do blood work and x-rays, and its all covered by the study.

Its unknown if Allogeneic stem cell therapy is as safe and effective as Autologous therapy. Dr. Christianson noted, The goal of the study is that sick pets could receive stem cell therapy without the pain and discomfort of surgery.

Sick and injured animals recuperating at the Island Animal Clinic have a goodwill ambassador to their lift their spirits. Dr. Ballards dog, Jiminy Cricket (Jim) is a daily visitor. Jim was an injured client. Practice Manager Holly Davis explains, He came in with two broken legs, and it was too much for his owner to handle. Jim was in two casts for months and needed round-the-clock care. Jim now goes to work daily with Dr. Ballard. He runs around the hallways when Dr. Ballard is on break, providing comic relief for recuperating pet patients.

Veterinary medical discoveries are providing a better quality of life and extending the lives of our furry friends. Its exciting that a local animal hospital is at the forefront of these emerging trends. Its also comforting to know recovering pets have Jim for inspiration.

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Study: heart failure stem cell therapy safe, shows early signs of effectiveness – The San Diego Union-Tribune

Wednesday, April 5th, 2017

A stem cell treatment for heart failure patients is safe and shows early signs of effectiveness, according to a study published Wednesday.

The study was conducted by Japanese researchers in 27 patients, who received transplants of stem cells taken from their own thigh muscles. There were no major complications, and most patients showed considerable improvement in their symptoms.

The study was published in the open-access Journal of the American Heart Association. Dr Yoshiki Sawa of Osaka University Graduate School of Medicine was the senior author. It can be found at j.mp/stemheart.

However, two San Diego cardiologists who do stem cell research on heart disease cautioned that similar clinical trials have shown promise over the years, only to fail at the end for various reasons. There is no approved stem cell therapy for heart failure.

So while the trial itself appears to be well-conducted, the researchers are very far from actually proving their treatment is effective, said Dr. Richard Schatz of Scripps Health and Dr. Eric Adler of UC San Diego School of Medicine.

For one thing, the trial was small, they said, and larger trials are where the most rigorous scientific evaluations are made.

These early trials have looked beneficial in the past, Adler said. When we do the larger trials, the results are more equivocal.

Adler said the signs of efficacy in this trial are modest. For example, the change in ejection fraction, a measurement of efficiency in pumping blood, rose from 27 percent to 30 percent in 15 of the 27 patients. Their heart failure was associated with a lack of blood flow, or ischemia. The remaining non-ischemic patients actually had a slight decline.

The entire field of stem cell and regenerative therapy for heart disease has been a disappointment to date, Schatz said.

Weve been at it for 20 years now, and we dont have a product or a positive (late-stage) trial, so that tells you pretty much everything you need to know, he said. Its not for lack of trying or billions of dollars invested. Its just very, very difficult.

The cardiac field has had more success with other technologies, such as cardiac stents. Schatz is the co-inventor of the first stent.

In the study, the researchers acknowledge that previous attempts had only been modestly effective. They devised a method of producing sheets of muscle stem cells and attaching them to the inner layer of the sac that encloses the heart, a layer that rests directly on the heart surface.

The stem cell sheets stimulate healing by producing chemicals that stimulate cardiac regeneration, the study said. The cells themselves dont survive in the long term, but by the time they die they have served their purpose.

Loss of function

Heart failure is a progressive disease in which the heart gradually loses its ability to pump blood. This can be triggered by a heart attack or any other cause that damages the heart muscle.

When damaged heart muscle is replaced with scar tissue, as often happens, the heart loses pumping capacity. It becomes overstressed, and its output of blood declines. This limits the patients ability to engage in intensive physical activity. In advanced cases, patients may become bedridden.

Existing treatments include drugs and LVAD units, which take over some of the hearts function to relieve stress. Some drugs may help the heart work more efficiently, but none have been shown to improve heart failure by actually regenerating lost heart muscle.

Stem cell therapy is tested in patients who havent responded well to other treatments. Trials have been and are being conducted in San Diego area hospitals.

Scripps Health has been testing a cardiac stem cell therapy from Los Angeles-based Capricor. The cells, taken from donor hearts, are injected into the coronary artery, where they are expected to settle in the heart and encourage regrowth.

UC San Diego is testing a heart failure therapy from Teva Pharmaceutical Industries. It consists of bone marrow derived mesenchymal precursor cells. These can give rise to several different cell types, including muscle cells.

And many other trials are going on throughout the country and internationally.

Adler and Schatz said theres reason for optimism in the long run, as technologies improve.

Just because the other trials have been negative doesnt mean this technique wont be beneficial, Adler said. Its just too early to tell.

That said, Schatz emphasized that the nature of the three-phase clinical trial process means that the show-stoppers for a treatment typically appear late.

Tighter standards needed

Clean trials trials where we all agree that this is the patient population we want to look at, are needed, he said.

For example, heart failure comes in two types, he said. Ischemic heart failure is caused by heart attacks and blocked arteries, which impede blood flow. Non-ischemic heart failure can be caused by damage from diseases, such as a virus.

Non-ischemics can be younger people, in their 20s and 30s, while the ischemic patients are older. Mixing those patient groups in a single trial is a mistake, he said.

Theyre different animals, Schatz said.

Another pitfall is failing to screen carefully enough to enroll only patients likely to benefit, Schatz said.

You can have a patient who has chest pain, and coronary disease just incidentally, he said.

His shoulder or chest pain is from a virus. So he goes into the trial and gets a placebo injection in his arm of cortisone, and his arm pain goes away. And because hes in that placebo group, hes counted as a success the pain went away. It has nothing to do with his heart. Thats an extreme example, but we actually saw that happen.

In a failed gene therapy trial for heart disease, some patients apparently had received the injection in the wrong location, missing the heart muscle, Schatz said.

You assume they got the gene, but they didnt, Schatz said. The study was negative, and thats why I think it was negative.

Such errors dont show up in Phase 1 trials, Adler and Schatz said, because theyre focused on evaluating safety. And these early trials dont have many patients, there arent enough to comfortably determine the therapy is really effective.

By the last stage of the trial, these sources of error have often been identified and trial standards have tightened up. And thats when the faulty assumptions made early appear as the trial ends in failure.

Despite those forbidding hurdles, Adler said research should continue.

This disease is killing a lot of people. Theres not going to be enough hearts to go around for transplant. Theres six million Americans with heart failure, and theres 2,000 heart transplants a year. So coming up with novel regenerative cell-based therapy is something were still excited about.

bradley.fikes@sduniontribune.com

(619) 293-1020

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Study: heart failure stem cell therapy safe, shows early signs of effectiveness - The San Diego Union-Tribune

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Bangladeshi patients treated with stem cell therapy in city – Mumbai … – Mumbai Mirror

Wednesday, April 5th, 2017

Bangladeshi activist and city-based medical centres collaborate to provide life-saving treatment for the three patients.

A Navi Mumbai-based treatment centre used stem cell therapy for the first time on three Bangladeshi patients suffering from an incurable muscular dystrophy.

The trio have been suffering from a rare disease called Duchenne Muscular Dystrophy, which causes progressive muscle degeneration, since birth. The disease limits the lifespan of the patient to just 30 years.

The doctors took stem cells from the patients bone marrow in the hip bone, processed it and injected it back into their bodies. The coordinator between the patients and the treating centre, Avantika Patil said, The patients are also undergoing physiotherapy and occupational therapy while we wait for the results of the procedure to show.

The treatment was made possible by the efforts of a Bangladeshi activist, Noor Khan, a Mumbai-based organisation, Meditourz, which worked in collaboration with a brain and spine institute from Navi Mumbai, NeuroGen.

It was NeuroGen which learnt about the three patients from an article in the international media and offered to treat their disease.

Of the three patients, the youngest, Shorab (8) has a mild disorder. This early medical intervention is expected to make his life less painful. However, the other two patients, Abdus (24) and Rahinul (14) are at a progressive stage.

Their father, Tofazzal Hossain, had even sought mercy killing from Bangladesh government for the duo as he could not afford the cost of their treatment. The travel arrangements were made in coordination with the Indian government. Free round-trip tickets were offered to six persons the patients and their caretakers who accompanied them to Mumbai from Kolkata, by Air India.

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Researchers will use stem cell therapy to grow heart muscle in new study – Cardiovascular Business

Wednesday, April 5th, 2017

The U.S. Food and Drug Administration (FDA) has approved a new study that will test the efficacy of a stem cell technique used on children suffering from congenital heart disease.

The study is being hosted by Boston Childrens Hospital and Mesoblast Limited, a regenerative medicine company based in Australia. Their 24-patient trial will test the efficacy of Mesoblasts proprietary allogenic mesenchymal precursor cells (MPCs) in a corrective heart surgery on children under the age of 5 that suffer from hypoplastic left heart syndrome (HLHS), according to an April 3 press release.

The new technique is designed to save more patients with HLHS because current treatment is not always effective. Right now physicians generally perform a single, ventricle palliation, which results in the patient using only the right ventricle to the support the hearts entire circulation. However, the treatment is usually only a temporary fix because the right ventricle will eventually tire out, putting the patient at an increased risk for sudden cardiac arrest.

In the randomized, controlled trial, researchers will inject Mesoblasts MPC-150-IM into the left ventricle during surgical recruitment procedures, which should improve ventricular mass and function and ultimately lead to a higher likelihood of biventricular conversion.

The objective of combining Boston Children Hospitals expertise in pioneering surgical approaches to treating hypoplastic heart syndrome with the regenerative potential of our lead cardiovascular product, MPC-150-IM, is to develop a highly innovative treatment for this complex congenital condition as well as other serious and life-threatening cardiac diseases in children, said Kenneth Brow, the senior clinical development executive and head of cardiovascular diseases at Mesoblast, in a statement.

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Premier Wellness Group Offers Regenerative Cell Therapy for Knee … – GlobeNewswire (press release)

Monday, April 3rd, 2017

April 02, 2017 10:00 ET | Source: Premier Wellness Group

CAPE CORAL, Fla., April 02, 2017 (GLOBE NEWSWIRE) -- Regenerative cell therapy offers residents a way to reduce pain and support their bodys healing process from auto accident injuries, personal injuries, and sports injuries. Painful acute and chronic injuries can be healed using amniotic stem cells. Patients can experience pain relief without drugs with regenerative cell therapy injections that use the growth factors in amniotic stem cells to stimulate healing. Regenerative cell therapy can allow patients a safe form of pain relief and reduce their reliance on pain medications. Regenerative cell therapy is available as part of a patients individualized treatment program by the medical team at Premier Wellness Group.

Regenerative stem cell therapy offers pain relief for auto accident injuries and personal injuries, such as patients dealing with shoulder pain, knee pain, and back pain. Stem cells are a powerful tool for healing. The specialized cells begin as blank cells in that they can be used to regrow any cell needed. It is possible to regrow new cells, muscle, and tissue without surgery. Uninjured stem cells are injected into a targeted area and develop into needed cells. Stem cell therapy supports the bodys own healing process, allowing patients to benefit from injury management without surgery or painkillers.

Patients do not need to worry about any reactions due to rejection, and the amniotic regenerative stem cell therapy process is the least evasive of other forms of stem cell therapy. Patients need little, if any, downtime and stem cell therapy complements chiropractic treatments, massage therapy, nutritional counseling, and corrective exercises to guide the body back into a state of wellness. Stem cell therapy can reduce inflammation, promote healing, and increase range of motion.

We are pleased to provide patients with a natural form of pain relief and rehabilitation that takes into account the bodys own ability to heal itself, said Dr. Patrick King. Regenerative cell therapy requires no surgery- only injections performed by our physician. Stem cell therapy is safe and most patients require no downtime. We invite residents suffering from pain or trauma due to a car accident injury, sports injury, or personal injury to contact our team to learn more about this advanced therapy for healing and recovery.

Dr. Patrick King, clinic director and owner of Premier Wellness Group, has served the chiropractic and rehabilitation needs of residents of Cape Coral, Fort Myers, and surrounding communities for more than 15 years. Patients have made Premier Wellness Group their destination for drug-free, non-surgical pain relief, and rehabilitation. Services at Premier Wellness Group include regenerative cell therapy, trigger point therapy, corrective exercises, lifestyle recommendations, and chiropractic care.

Call (239) 573-7988 to learn more about Cape Coral regenerative cell therapy for knee and shoulder pain relief, or to schedule an appointment. Visit http://www.mypremierwellnessgroup.com/ for additional details.

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The risks of unproven stem cell treatments – Radio New Zealand

Monday, April 3rd, 2017

An expert in stem cell treatment is warning of dodgy operators in New Zealand offering unproven and potentially dangerous treatments.

Auckland University Medical School lecturerBronwen Connor's warning comesafter arecently-released scientific paper documented a case of three women in the United States who were blinded by an experimental treatment for macular degeneration.

She said many people had stem cell therapy in the belief it was scientifically valid, but that was not often the case.

Dr Connor told Nine To Noon the cells used most often for the treatments were known as adipose cells, which were obtained from fat tissue in the body. They were popular because they couldbe obtained from a patientby liposuction, isolated out, then re-injected for supposed therapeutic use.

"Adipose stem cells obviously have a very important job, but predominantly their job is to make bone and cartilage. They also do have some anti-inflammatory properties. But they, to date, have not been shown to have any potential or ability to generate brain cells, for example, or new kidney cells or heart cells."

Websites for clinics offering the treatments listed up to 20 or 30 different types of diseases, disorders or conditions that one source of cells could supposedly treat. That was worrying, she said.

Adipose stem cells might be the right choice to help repair cartilage damage in the knee. "However, it wouldn't be your stem cell choice if you ... had Parkinson's disease and you were going to try and replace some of those lost cells in your brain."

Dr Connor said people needed to be sceptical and check if, for example, there hadbeen any human clinical trials involving the treatment.

"There are always dangers around treatments that we haven't taken out long-term and which there haven't been sufficient rigorous human clinical trials undertaken [on]. This is the purpose of clinical trials, to see what is the safety aspect and the efficacy of this procedure."

She advisedpeople to think about it in terms of medicines and drugs that people were used to taking, like aspirin. "If you inject yourself with a stem cell population and you have a bad side effect, you can't get those cells out. So ... we really need to know what those cells are going to do long-term and what any potential risk is, because they cannot be retrieved."

The Ministry of Health did not regulate stem cell therapy in this country because the cells were not regarded as medicine. She said it was a grey area, because cells were being taken from a patient and re-injected into the same patient with their consent. "But really, moving forward in the next 10 to 20 years, we're going to see more and more of these type of therapies that don't involve a pill or a tablet or our traditional thought of a medicine, and we really need to get regulations around that type of therapy."

She had spoken to people who paid large sums of money for the treatments.

"When I questioned them a little bit more ... did it help, they would sort of sheepishly say 'well, no not really'."

Dr Connor said clinics offering the treatments often emphasised the benefits according to the scientific literature, but it might be benefits in animals - not from human trials. She wanted quality control addressed and standardisedprocedures, along with safety and efficacy.

Dr Connor wanted to see clinical trials of many of the therapies,as they hadpotential. "Our fear is that, as with the three women with the macular degeneration, is that anything that goes wrong will really hinder the field because people will just see it as stem cell therapy."

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The stem cell therapies offered by this La Jolla clinic aren’t FDA … – Los Angeles Times

Saturday, April 1st, 2017

Jim Durgeloh, 59, was desperate to avoid surgery. After a career as a construction contractor and hours of leisure time spent on a motorcycle around his Longview, Wash., home, he was facing an operation to replace his left hip.

Thats pretty invasive, he said, nervous about a surgery that would require being cut open and implanted with an artificial hip; Jims brother had died from complications after a similar operation. In the search for an alternative, he and his wife, Janet, happened upon the website for La Jolla-based StemGenex Medical Group, which touts itself as the worlds first and only Stem Cell Center of Excellence.

But what caught the Durgelohs attention were the words of Rita Alexander, its chief administrative officer and a founder.

Alexander wrote that she had suffered debilitating rheumatoid arthritis until a stem cell treatment sent her into remission. Today it remains my passion to advocate for those diagnosed with debilitating illnesses to have access to cutting edge stem cell treatment, she wrote.

Rita was very inspiring, Janet Durgeloh says.

Durgelohs doctor in Washington was skeptical about the therapy offered by StemGenex. He didnt think it was going to work, Durgeloh says. The therapy isnt approved by the Food and Drug Administration, which says such treatments are not based on scientific evidence and can be unsafe. Then there was the cost: about $15,000, not including airfare. That wasnt covered by Durgelohs insurance, which would have paid for his hip replacement.

But on a recent Wednesday morning, the Durgelohs were at the DoubleTree hotel in Del Mar, where their bill was paid by StemGenex. Durgeloh was still wearing a bandage on his midriff, where a StemGenex doctor had performed liposuction to obtain stem cells that subsequently were reinjected into his body, ostensibly to regenerate his damaged bones and tissues. They were preparing to fly home, infused with the hope communicated by the clinic staff, who seemed very optimistic, Durgeloh told me.

A lawsuit in San Diego federal court suggests that StemGenex may have given the Durgelohs nothing but hope. Three StemGenex patients two with diabetes and one with lupus say they were misled by the medical groups marketing pitch to pay $14,900 each in 2015 and 2016 for therapies that have had no effect.

The lawsuit, which seeks class-action status, claims that StemGenex has made its money by targeting the ill and the elderly with false, fabricated and purposefully misleading claims about patient satisfaction. Selena Moorer, a lupus patient from Florida, and her two co-plaintiffs say StemGenex has no reasonable basis for its marketing claim that the Stem Cell Treatments were effective to treat diseases as advertised. The lawsuit names StemGenex, Alexander and Andre Lallande, the groups chief medical officer, as defendants. The company denies the claims made in the lawsuit.

Durgelohs treatment was typical of the procedures offered as stem cell therapy. He says he received injections directly into his hips, his ailing knees and his back, with whatever was left over suffused into his body via an IV drip.

Whats most important to know is that theres no accepted scientific evidence that treatments using cells from adipose fat tissue layers work.

But as we reported last year, many clinics offering the treatments capitalize on the publics impression that stem cells have become some sort of medical miracle. Dr. Mehmet Oz warned his vast television audience about this misconception in February, when he aired a lengthy undercover investigation of stem cell clinics and called for government regulation. StemGenex wasnt mentioned in the piece.

StemGenex, in its reply to the Moorer lawsuit, asserts that the plaintiffs cannot prove that its representations regarding the efficacy of its stem cell treatments are actually false. The plaintiffs, it continues, do not cite to a single scientific study that disproves [StemGenexs] advertised claims.

StemGenex may not have to prove that in a court of law, but thats not the way federal regulation works. At nearly $15,000 a pop, the companies should have to show a treatment works.

The FDA has been grappling with this very point in pondering how to regulate the burgeoning industry. There are more than 500 clinics offering stem cell treatments in the U.S., according to a survey released last year by stem cell scientist Paul Knoepfler of UC Davis and bioethicist Leigh Turner of the University of Minnesota.

Right now, theres no consensus how these clinics should be regulated.

In 2015, UC San Diego researchers described stem cell treatment as medicines Wild West. As Hermes Taylor-Weiner and Joshua Graff Zivin observed, Because FDA guidelines are ambiguous, stem-cell clinics have in effect been operating without regulation.

The proliferation of the clinics has forced the FDA to take a closer look.

The government agency maintains that using stem cells extracted from a patients fat requires licensing as a drug, device or biological product, which means the clinics have to demonstrate the products are safe and effective, possibly via a clinical trial.

The clinics obviously disagree. Steven Brody, chief scientific officer of StemGenex, testified at an FDA hearing in September that if the FDA took a hands-off approach, this would help our patients have access to stem cell therapies.

Earlier this month, the New England Journal of Medicine reported the devastating outcome for three elderly women injected with fat-derived stem cells directly into their eyeballs by a clinic in Florida as a treatment for macular degeneration. The treatment left the patients totally or mostly blind.

Stem cell clinics typically are cagey about what patients should expect. They neither claim their treatments are effective nor explicitly state that theyre unfounded, Taylor-Weiner and Zivin observed. Their language is intentionally imprecise and exploits the vulnerability of patients with debilitating diseases.

Indeed, a disclaimer on the StemGenex home page states, Stem cell therapy is not FDA approved, and, StemGenex Medical Group and affiliates do not claim that treatment using autologous stem cells are a cure for any condition, disease, or injury.

Thats a striking admission for a treatment costing nearly $15,000 out-of-pocket and might help explain why health insurers shun the treatments.

The emotional video testimonials from patients posted on the StemGenex website carry disclaimers that the results experienced by those patients may not be typical or expected. You should not expect to experience these results.

When I asked Jamie Schubert, a StemGenex spokeswoman, to point me to a scientific study or any other evidence that its treatments work, she replied that anecdotal feedback from patients indicates that their symptoms have improved and their quality of life has increased.

There are other red flags. One of the medical groups physicians, plastic surgeon Scott Sessions, was placed on three years probation by the California Medical Board in February. He was accused of negligence related to cosmetic surgery and other procedures he performed on two patients at an unrelated facility in 2011 and 2013.

Schubert told me Wednesday that Dr. Sessions has informed us that he is in compliance with all requirements of the probationary terms of the medical board. But the very next day, his name, photograph and bio had disappeared from the StemGenex website. Sessions didnt respond to a request for comment.

The same thing happened with the logo of the American Board of Surgery, which had been prominently displayed on the StemGenex site, implying the company had the certification boards seal of approval. After I mentioned to Schubert that a board official told me that display was a complete misuse of our logo, it vanished. Schubert called it an error.

Peoples health needs are not suitable for unregulated Wild West experimentation, and anecdotal feedback isnt proof that cutting edge treatments are safe and effective. The course couldnt be clearer for the FDA and state medical regulators across the country: If these stem cell clinics are endangering their customers health and draining their pocketbooks for quack remedies, shut them down.

Keep up to date with Michael Hiltzik. Follow @hiltzikm on Twitter, see his Facebook page, or email michael.hiltzik@latimes.com.

Return to Michael Hiltzik's blog.

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The stem cell therapies offered by this La Jolla clinic aren't FDA ... - Los Angeles Times

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Stem cell therapy restores sexual function in impotent men … – TheHealthSite

Friday, March 31st, 2017

Stem cell therapy can restore sufficient erectile function to allow previously impotent men to have spontaneous intercourse, show results of an early clinical trial.What we have done establishes that this technique can lead to men recovering a spontaneous erection in other words, without the use of other medicines, injections, or implants, said lead researcher Martha Haahr from Odense University Hospital in Denmark.Results presented at the European Association of Urology conference in London showed that eight out of 21 participants in the study successfully regained sexual function.We are now beginning a larger Phase-2 trial to better evaluate its effectiveness and confirm its safety, Haahr said.In recent years several groups have worked to develop stem cell therapy as a cure for erectile dysfunction, but until now the improvements have not been sufficient to allow affected men to achieve full sexual intercourse. Erectile dysfunction to some degree affects nearly half of men between the ages of 40 and 70.There are several possible causes, including surgery (for example, prostate surgery), high blood pressure, diabetes, cardiovascular disease and psychological problems.

Current remedies which include medications such as PDE5 inhibitors (such as Viagra and Cialis), injections, or penile implants have some disadvantages, so scientists have been searching to find a way which restores natural sexual function.The present work focuses on patients with physical damage, caused by surgery (radical prostatectomy) for prostate cancer.The research group, from Odense in Denmark, used stem cells taken from abdominal fat cells via liposuction (under a general anaesthetic).None of the 21 men reported significant side effects over the trial period, or in the following year, according to the study.After isolating the stem cells, they were injected into the corpus cavernosum area of the penis. The patients were able to be discharged the same day.Within six months of the treatment, eight of the 21 patients reported that they had recovered sufficient erectile function to achieve penetrative sexual activity. This improvement has been maintained for a year, indicating that this treatment may confer long-term benefits. We are the first to use a mans own fat stem cells as a treatment for erectile dysfunction in a clinical trial. The technique has been trialed in animal work, but this is the first time stem cell therapy has allowed patients to recover sufficient erectile function to enable intercourse, Haahr said.

Source: IANS

Image source: Shutterstock

Published: March 31, 2017 11:10 am

Disclaimer: TheHealthSite.com does not guarantee any specific results as a result of the procedures mentioned here and the results may vary from person to person. The topics in these pages including text, graphics, videos and other material contained on this website are for informational purposes only and not to be substituted for professional medical advice.

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Shareholders in WideCells in good position to benefit from stem cell therapy advances – Proactive Investors UK

Thursday, March 30th, 2017

WideCells is aiming to be a major supporting player through its development of a stem cell storage business and, having only listed in London last July, its newsflow so far looks to be pointing the way

With stem cell therapies tipped to be the next great advances in the treatment of a range of ailments and conditions, shareholders in PLC () look to be in a good position to benefit.

WideCells is aiming to be a major supporting player through its development of a stem cell storage business and, having only listed in London last July, its newsflow so far looks to be pointing the way.

In the groups maiden full-year results statement today, WideCells chief executive Joao Andrade pointed out that it has made significant progress in the commercialisation of our stem cell services; the roll out of our revolutionary stem cell insurance product CellPlan has now commenced in collaboration with the UK's largest stem cell storage facility, Biovault.

He added that discussions with multiple other facilities are advancing rapidly; delivery of our first stem cell processing and storage facility in Manchester is on track for Q2 2017.

He also noted that the group recently appointed the former head of Education, Alan Greenberg, as a non-executive director and vice president of the WideAcademy to devise a strategy that makes it the thought leader in the stem cell industry.

The WideCells boss said, "Our activities during the period have ideally positioned us to start generating revenues in 2017 from all three WideCells divisions, which work together to create the world's rst end to end service solution focused on making cord blood stem cell treatment accessible and affordable globally.

Like most developing companies, the group - which raised 2mln when it floated on the main market - only had revenues of 25,000 for the full-year to December 31 2016, down from 50,644 a year earlier, while its loss for the year increased to 1.361mln, up from 213,056 a year earlier reflecting higher administration costs following flotation.

But Widecells had cash and cash equivalents of 1.149mln at the year-end, up from 33,753 a year earlier.

When the firm announced last November that its CellPlan subsidiary had signed a non-binding letter of intent to offer its stem cell treatment insurance to clients of the human tissue storage facility Biovault Technical, Andrade called the deal transformational.

Biovault has a register of over 25,000 customers which WideCells will have access to for an initial five year term.

While stem cell storage costs a few thousand pounds, the cost of the treatments that use them can run into the hundreds of thousands.

For an average premium of 150 per year, CellPlan provides insurance for up to 1mln of treatment, travel, accommodation and repatriation costs.

CellPlan is to be based in Porto, Portugal, which gives it access to the wider European stem cell market and from where licences will now be arranged for a rapid roll-out.

Aside from the CellPlan deal, WideCells opened up a second revenue stream in December when it inked a letter of intent with a California-based medical device company that could be worth up to 100,000.

Qigenix agreed to pay the sum in three stages so it can use Widecells' Institute of Stem Cell Technology (ISCT) in Manchester to undertake some research.

WideCells third revenue stream comes from its blood banking operations, for which the group inked two more outlying deals at the end of January to take it into the rapidly expanding Brazilian umbilical cord cell storage market.

Between them, the two new reputable storage and processing facilities had more than 5,000 high net worth clients on their books.

The Brazilian cord blood banking market is projected to be worth almost US$450mln by 2023, making it the largest in South Americas booming stem cell industry.

In all, there are 500 of these banks dotted around the world; however, the top ten banks store around half the samples.

These three strands provide the roots for the optimism of WideCells boss although the share price looks to have failed to respond yet to the opportunities he sees.

WideCells floated at 11p per share in July, since when the share price has fluctuated, hitting a peak of 16.25p in the middle of October, but this year it has drifted sitting at around 12.25p currently.

According to sources, there was plenty of interest in WideCells unique story at flotation, meaning the IPO was oversubscribed. Among the shareholders who came on board at float was Miton Group, which stumped up 500,000.

But it looks like the story needs to be wider known, which is probably where the appointment of the former head of Education comes in.

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Innovative technology gives patients new beginnnings – Manhattan Mercury (subscription)

Thursday, March 30th, 2017

By The Mercury March 29, 2017

Linda Graham and the sales staff at Carpet One in Manhattan.

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What if someone told you that your own body could potentially help heal a physical condition affecting your everyday life? Stem cell therapy makes this possible every day at the Kansas Regenerative Medicine Center. Located in Manhattan, KRMC is the Midwest leader in adult stem cell therapy, treating over 1,000 patients to date for orthopedics, osteoarthritis, back, neck, and spine, neurological, and some autoimmune diseases.

Stem cells are your bodys natural healing cells. These tiny cells have the potential to recognize tissue injury and repair damaged cells. Trapped inside of your own body adipose fat is an extremely rich source of these stem cells.

Through a relatively painless liposuction procedure, highly trained physicians at KRMC can harvest your stem cells from your own fat and administer them into tissues, joints, or veins. Stem cell therapy is minimally invasive, requires no general anesthesia, and can potentially serve as an alternative to major surgery.

This treatment is new and upcoming, according to Kate Farley, Director of Marketing & Business Development at KRMC.

We are on the cutting edge of this innovative technology, which will be a big part of regenerative medicine in the near future, she said.

Stem cell therapy has been in practice for decades in foreign countries. In the USA, veterinarians have been using stem cell therapy on animals for a little over 10 years and some pioneering physicians for over five years.

KRMC has been open for three years this month, and is one of the largest stem cell treatment centers in the country that focuses solely on stem cell therapy. The fact that they receive a great amount of their patients from referrals shows how successful KRMC has been. Farley has witnessed this first-hand.

Stem cell therapy is a very intricate process, so you have to do it all the time to be good at it, but thats what were doing all day every day, she said. We also strive to treat each patient like family in order for them to have the best experience possible. Any patients coming from out of town, we offer a hotel room for no extra charge, just as an added gesture, she said.

At KRMC, the physicians have treated patients aging anywhere from 15 to 95. There is never a guarantee of success, but they have experienced patient satisfaction rates, around 85%, in cases related to arthritic conditions.

Although it is still unknown as to why stem cell therapy works on some people and not on others, Farley urges people with conditions affecting their everyday routine to look into this alternative treatment.

There are no guarantees, and thats something people need to know, but there are no negative side effects, she said. We help people get back to their normal routine. It is not uncommon for patients to one day realize they just did a physical activity they hadnt done in years. It just seems like the most simple tasks, but these are things that run their life, she said.

Currently, stem cell therapy is considered patient funded research and is not covered by medical insurance yet. The cost of treatment varies depending on the condition being treated. Patients who have undergone stem cell therapy and found success will tell you that every penny is worth it.

Linda Graham, 56, is one of those patients.

For about 10 years, Graham dealt with severe arthritis pain in her joints. The progression was gradual at first, and it became noticeable when she started feeling pain in her joints while doing things she normally did.

It started affecting different parts of her life, including work. Graham has owned Carpet One Floor and Home in Manhattan for decades, and the pain in her joints started interfering with how she operated the store. Youre just not able to do the things youve been able to do, like my job, she said. We move a lot of tile and stuff, and I really couldnt do that anymore.

Even lifting and bending became difficult for her.

Before turning to KRMC, Graham had attempted several things to try to improve her condition, including several spinal block injections in her back and physical therapy.

Pretty much Id done everything that had been suggested to do for it, and none of it helped at all, she said.

Things changed around seven months ago when Grahams sister-in-law told her about someone she knew who had gone to KRMC for their shoulder and had a good response to the treatment.

Graham began researching stem cell therapy, called the center, and eventually met with Dr. Lyons. After visiting with him, she decided it sounded like something she wanted to try.

They explained everything very well to me, she said. So I understood the process and knew exactly what was going to be going on.

I was excited to try it because it was something that could be done. I couldnt have any more surgeries on my back, and I was excited to use something that could possibly make me feel better that uses my own stem cells. I wasnt hesitant because I was very comfortable with the doctors and what they had to say.

The day Graham went in for the treatment, she received a total of 32 injections in her back, neck, and left hip. One might think this would be a painful procedure, but Graham said otherwise.

It wasnt painful, she said. You know, to some people it might be, but Im used to having injections and stuff in my back.

It was just three weeks later when Graham noticed a huge difference in her back. She started being able to do simple tasks that, before the treatment, had caused unbearable pain. Getting up and down out of her chair, picking things up, putting socks on, and even simply standing would cause her pain. But not anymore.

The stem cell therapy has greatly improved Grahams quality of life, especially at Carpet One, where she usually works 60 hours a week.

I think it just made me a better person here at work when youre not constantly in pain in things that you do, she said. I dont have to take Ibuprofen and that stuff constantly. I dont take pain medication. I think it just made me an overall better person to be around.

Graham is extremely appreciative of what KRMC has done for her. She hopes others with symptoms similar to hers will look into stem cell therapy and not be afraid. Duane Hund has had a similar experience with KRMC.

In 2010, Hund, who was 54 at the time, went in to his orthopedic doctor to do a scope of his left shoulder due to constant pain. After the scope, he learned he had no cartilage left in his shoulder. With the only advice he was given being try to live with it as long as possible, Hund spent the next five years struggling with the condition. He woke up every night to stabbing, searing pain in his shoulder.

It got to the point where his wife was worried about him driving because of how little sleep he would get each night.

It was real common for me to wake up multiple times during the night because of the pain, he said.

It affected other aspects of his life as well. He was limited to what he could lift while working in the cattle business, and found himself limited to what he could do at home.

It was painful for me to change a lightbulb raising that left arm all the way up, he said. I would notice that if I had an easy day, I would wake up less often at night.

He felt like he had exhausted almost every single one of his options, from physical therapy to over-the-counter drugs, and found that nothing was effective.

Then, KRMC opened.

Hund and his wife started doing research on stem cell therapy since they knew the doctors at the center that would eventually perform his procedure Lyons and Dr. Pope.

Hund reached the point where he was prepared to make serious changes. It was either the stem cell therapy or replacing his entire left shoulder.

He and his wife eventually took Hunds X-rays to the center. Lyons and Pope looked at them and told Hund they were 85% sure they could help him. After they thoroughly described the process, Hund felt very comfortable.

It made me feel like these guys are experts, he said.

After that, any hesitation regarding the treatment was gone.

Something had to change with my sleeping problem, he said. If the stem cell therapy didnt work, I knew what the alternative was.

Hund ended up going in for treatment in July of 2015. He still recalls that day very well, remembering lying down on the table where Dr. Pope gave him the practically painless stem cell injection.

The days that followed brought no change. That is, until about six weeks later, when Hund woke up one morning realizing he had not woken up a single time during the night.

The first time I slept through the night, it was like did that really happen? he said.

Since that night, he said it continued to get better as time went on. He now sleeps through the night, and can continue to live his everyday routine with minimum restriction.

As a side note, Hund mentioned that, in addition to the treatments aimed at improving his shoulder, the stem cell treatment also rid him of some symptoms associated with the early stages of P a r k i n s o n s . KRMC noted that this type of positive side effect is not uncommon. Hund is extremely grateful that his treatment from KRMC has allowed him to continue to live out his active lifestyle.

Hund and his wife Diane of 36 years both work on a farm that has been in Hunds family for five generations since 1872.

I can continue to do what I love to do in the cattle business, he said. My wife and I would have had to quit if the pain kept up.

In addition to their farm, the Hunds also have kids and grandkids. Because of the stem cell therapy, he can now physically pick up his grandkids, something he was unable to do before.

I can be a better grandpa and a better husband, and still do the things I love to do, he said. Its been a wonderful opportunity. It doesnt work for everyone, but Ive had great success with it. I thank the Lord for that every day.

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Nohla and UC Davis Ink Manufacturing Deal for Off-the-Shelf Donor Stem Cell Therapy – Genetic Engineering & Biotechnology News

Wednesday, March 29th, 2017

Nohla Therapeutics is tapping the University of California, Davis (UC Davis) for its expertise in cell therapy GMP and manufacturing so that it can scale up clinical trials manufacture of NLA101, Nohla's Phase IIb-stage off-the-shelf universal donor stem and progenitor cell therapy for hematologic cancers. The firm will also work with UC Davis to further optimize the NLA101 manufacturing process, with a view to future commercial production.

Under terms of the collaboration and manufacturing agreement, UC Davis will carry out manufacturing and quality control testing of NLA101 at the UC Davis Institute of Regenerative Cures (IRC) cGMP Cell Therapy Manufacturing Facility in Sacramento, CA. Nohla has sublicensed office and laboratory space at the Oak Park Research Center next to the IRC, which will act as a warehouse and distribution center for supplying the IRC with raw materials and for storing NLA101 for distribution to the clinical trials sites. The collaboration will enable the production of enough NLA101 to supply clinical trials evaluating NLA101 in hematopoietic cell transplant and for treating chemotherapy-induced neutropenia.

This collaboration allows Nohla to capitalize on the expertise at UC Davis to scale manufacturing for NLA101 and increase our ability to supply product for multiple clinical trials, commented Kathleen Fanning, president and CEO at Nohla.

Lars Berglund, M.D., Ph.D., associate vice chancellor for biomedical research and vice dean for research at UC Davis School of Medicine, added, We are particularly excited to partner with Nohla for the development of this groundbreaking technology as it demonstrates our commitment to work with innovative companies developing lifesaving therapies.

Nohla was established in 2015 to exploit technology developed at the Fred Hutchinson Cancer Research Center, which enables the Notch-mediated ex vivo expansion and directed differentiation of cord blood stem and progenitor cells into off-the-shelf universal donor cell therapies that can be used on demand without human leukocyte antigen (HLA) matching in recipients.

The lead product NLA101 has been evaluated in more than 100 patients at high risk of severe infection and other complications after chemotherapy or cord blood transplantation. A Phase IIb study is ongoing in patients undergoing myeloablative cord blood transplant for leukemia and other blood cancers. Nohla is also planning to start a Phase II study in patients undergoing high-dose chemotherapy for acute myelogenous leukemia (AML).

In November 2016, Nohla raised $43.5 million in a Series A financing round, taking total investment in the company to $64.5 million.

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Nohla and UC Davis Ink Manufacturing Deal for Off-the-Shelf Donor Stem Cell Therapy - Genetic Engineering & Biotechnology News

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Potential of stem cell therapy to repair lung damage — ScienceDaily – Science Daily

Wednesday, March 29th, 2017

NDTV
Potential of stem cell therapy to repair lung damage -- ScienceDaily
Science Daily
A new study has found that stem cell therapy can reduce lung inflammation in an animal model of chronic obstructive pulmonary disease (COPD) and cystic ...
Study shows potential of stem cell therapy to repair lung damageEurekAlert (press release)
Stem Cell Therapy May Help Treat Lung Inflammation and Damage: StudyNDTV

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Stem Cell Therapy Restores Sexual Function In Impotent Men – News18

Monday, March 27th, 2017

Stem cell therapy can restore sufficient erectile function to allow previously impotent men to have spontaneous intercourse, show results of an early clinical trial.

"What we have done establishes that this technique can lead to men recovering a spontaneous erection -- in other words, without the use of other medicines, injections, or implants," said lead researcher Martha Haahr from Odense University Hospital in Denmark.

Results presented at the European Association of Urology conference in London showed that eight out of 21 participants in the study successfully regained sexual function.

"We are now beginning a larger Phase-2 trial to better evaluate its effectiveness and confirm its safety," Haahr said.

In recent years several groups have worked to develop stem cell therapy as a cure for erectile dysfunction, but until now the improvements have not been sufficient to allow affected men to achieve full sexual intercourse.

Erectile dysfunction to some degree affects nearly half of men between the ages of 40 and 70.

There are several possible causes, including surgery (for example, prostate surgery), high blood pressure, diabetes, cardiovascular disease and psychological problems.

Current remedies -- which include medications such as PDE5 inhibitors (such as Viagra and Cialis), injections, or penile implants -- have some disadvantages, so scientists have been searching to find a way which restores natural sexual function.

The present work focuses on patients with physical damage, caused by surgery (radical prostatectomy) for prostate cancer.

The research group, from Odense in Denmark, used stem cells taken from abdominal fat cells via liposuction (under a general anaesthetic).

None of the 21 men reported significant side effects over the trial period, or in the following year, according to the study.

After isolating the stem cells, they were injected into the corpus cavernosum area of the penis. The patients were able to be discharged the same day.

Within six months of the treatment, eight of the 21 patients reported that they had recovered sufficient erectile function to achieve penetrative sexual activity.

This improvement has been maintained for a year, indicating that this treatment may confer long-term benefits.

"We are the first to use a man's own fat stem cells as a treatment for erectile dysfunction in a clinical trial. The technique has been trialed in animal work, but this is the first time stem cell therapy has allowed patients to recover sufficient erectile function to enable intercourse," Haahr said.

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Symposium discusses latest and future of stem cell therapy – The Pasadena Star-News

Sunday, March 26th, 2017

DUARTE>> Dozens of doctors, scientists, businesses and others gathered at City of Hope Thursday for the second California Institute for Regenerative Medicine (CIRM), Alpha Stem Cell Clinics symposium.

CIRM, the states stem cell agency, has developed a network of Alpha Stem Cell Clinics that focus on innovative stem cell-based therapies. The network of three clinics are located at City of Hope, University of California, San Diego, and UCLA/UC Irvine campuses.

The event served as a way for clinics to share their most recent advancements and successes in stem cell therapy clinical trials, and even hear directly from patients who benefited from some of the trials.

We want to review the trials, but we also want to see what other questions we should be asking, said Dr. John Zaia, the Aaron Miller and Edith Miller Chair in Gene Therapy, and director of the Center for Gene Therapy and principal investigator of City of Hopes Alpha Stem Cell Clinic. How will insurance companies charge or pay for these treatments? How do companies plan to develop these treatments? The symposium provides an opportunity to think about these other aspects.

There were also panel speakers who offered more of a motivational talk, such as Pat Furlong, founding president of Parent Project Muscular Dystrophy, discussing how to remove stakeholder barriers to stem cell therapy treatment.

Furlong had to become her and her sons own advocate when they were diagnosed with Duchenne Muscular Dystrophy at a young age. She found there was no standard of care for the disease and no studies or trials in progress to find a treatment, let alone a cure.

Families just didnt know the questions to ask, she said. At the time, few people cared about rare diseases.

After years of no real hope and losing her sons at 15 and 17 years old, with her and her groups persistence, Furlong said there are now 40 companies researching the disease and millions of dollars have gone into research specifically for Duchenne.

City of Hopes Dr. Behnam Badie, chief of neurosurgery and director of the Brain Tumor Program, and Christine Brown, Ph.D., Heritage Provider Network Professor in Immunotherapy and associate director of the T Cell Therapeutics Research Laboratory, discussed their recent successful treatment of a patient with recurrent multifocal glioblastoma using CAR-T cell therapy.

The case study for this unique type of immunotherapy on the most aggressive form of brain cancer was published in the Dec. 29 edition of the New England Journal of Medicine.

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In the Phase I clinical trial, the patient, who did not respond to other types of therapy including radiation and even developed tumors in his brain and spinal cord, was treated with his own genetically modified chimeric antigen receptor (CAR) T cells, injected directly into the tumor and through the ventricular system. The patient experienced remission over 8 months.

City of Hope is one of a few cancer centers in the nation offering studies in CAR-T cell therapy, and is the only cancer center investigating CAR-T cells targeting the specific receptors more common in a majority of glioblastomas.

Dr. Badie and Brown noted that working with CIRM has been instrumental in helping them along with their trial, and not just the funding.

You cant create a good trial without studying the product, said Brown. These are expensive trials. We have to treat these patients and understand what is going on.

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Erectile dysfunction: Stem cell therapy restores sexual function in phase I trial – Medical News Today

Sunday, March 26th, 2017

Early results of a clinical trial suggest that stem cell therapy may be a promising treatment for erectile dysfunction, after the procedure was found to restore sexual function in men with the condition.

The stem cell therapy involves injecting the patients' own stem cells - derived from abdominal fat cells - into the erectile tissue of the penis.

Lead researcher Dr. Martha Haahr, of Odense University Hospital in Denmark, and colleagues found that within 6 months of the procedure, 8 of the 21 men treated were able to engage in spontaneous sexual intercourse.

The researchers recently presented their findings at EAU17 - the European Association of Urology's annual conference - held in London in the United Kingdom.

Erectile dysfunction (ED) is a condition whereby a man has difficulties getting or maintaining an erection in order to engage in sexual intercourse.

According to the National Institute of Diabetes and Digestive Kidney Diseases, around 12 percent of men under the age of 60, and 22 percent of men aged between 60 and 69, have ED.

High blood pressure, diabetes, heart disease, chronic kidney disease, and prostate surgery are some of the physical conditions that can cause ED. Psychological issues - such as anxiety, stress, depression, and low self-esteem - can also contribute to ED.

Current treatments for ED include PDE5 inhibitors (such as Viagra), penile implants, and injections. However, Dr. Haahr and team note that all of these therapies can have significant side effects.

As a result, researchers are on the hunt for alternative treatments for ED, and stem cell therapy has emerged as a promising candidate in animal trials.

In their phase I trial, Dr. Haahr and colleagues tested stem cell therapy on 21 men who had ED as a result of undergoing radical prostatectomy for prostate cancer. None of the men had responded to standard medical treatment for ED.

For the stem cell procedure, abdominal fat cells were extracted from each man through liposuction. Stem cells were then isolated from the fat cells and injected into the corpus cavernosum of the penis - the spongy tissue that normally becomes filled with blood during an erection.

Before the stem cell procedure and 6 and 12 months after, the participants' erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire. An IIEF score of 5-7 represents severe erectile dysfunction, 12-16 is mild to moderate erectile dysfunction, and 22-25 is no erectile dysfunction.

All 21 men saw their erectile function improve with stem cell therapy: their IIEF score increased from 6 prior to treatment to 12 at 6 months after treatment.

Eight of the men reported that they had been able to engage in spontaneous sexual activity 6 months after stem cell therapy, and this outcome remained evident at 12 months after treatment. These men saw their IIEF score rise from 7 to 14 with stem cell therapy.

"What we have done establishes that this technique can lead to men recovering a spontaneous erection - in other words, without the use of other medicines, injections, or implants," says Dr. Haahr.

Although the study findings are preliminary, the team says that they show promise for stem cell therapy as an effective treatment strategy for ED.

"We are the first to use a man's own fat stem cells as a treatment for erectile dysfunction in a clinical trial. The technique has been trialed in animal work, but this is the first time stem cell therapy has allowed patients to recover sufficient erectile function to enable intercourse," says Dr. Haahr.

"We are pleased with the preliminary outcomes, especially as these men had previously seen no effect from traditional medical treatment and continue to have good erectile function after 12 months follow-up, indicating that this might be a long-term solution.

This suggests the possibility of therapeutic options for patients suffering from erectile dysfunction from other causes. But we need to remember that this is a small trial, with no control group. We're still some time away from a clinically available solution."

Dr. Martha Haahr

The researchers are now in the process of initiating a phase II trial to further investigate the safety and efficacy of stem cell therapy for ED.

Learn how eating more fruits could help to lower the risk of ED.

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Strong Progress for Paralyzed Patients After Stem Cell Therapy, Company Says – KQED

Friday, March 24th, 2017

A small stem cell trial in which patients with severe spinal injuriesappeared to make remarkable progress is still showing excellent results, according to the company conductingthe research.

One of the patients in the trial is 21-year-old Kris Boesen, from Bakersfield, California, whose story we reported on last year.A car crash had left theBakersfield, California native with three crushed vertebrae, almost no feeling below his neck, and a grimprognosis. Doctors believed he would live the rest of his life as a paraplegic.

Enter stem cell therapy. Most treatments for serious spinal injuries concentrate on physical therapy to expand the range of the patients remainingmotor skills and to limit further injury, not to reverse the actual damage. But last April, as part of an experimental phase 2 clinical trial called SCiStar, researchers injected Boesen with 10 million stem cells. By July, hehad recovered use of his hands to the point where he could use a wheelchair, a computer and a cellphone, and could take care of most of his daily living needs.In recent months his progress has continued, says his father.

Boesen is not the only patient to have improved in the trial, according toAsterias Biotherapeutics, which is conducting the research. Boesen is part of a cohort of six patients who were experiencing various levels of paralysis and were injected with the 10 million stem cell dose. In a Jan. 24update, the company saidfive of those patientshad improved either one or twolevels on a widely used scale to measuremotor function in spinal injury patients.

On Tuesday, Asterias issued a newupdate, announcingthat the sixth patient in the cohort has experienced a similar improvement.

While spontaneous recovery for spinal injury patients does occur,the likelihood of all six patients recovering to the degree they haveis less likely, researchers say.

This is as good as you could hope at this point, said Charles Liu, Boesens neurosurgeon and director of the USC Neurorestoration Center. So far all the evidence is pointing in the right direction.

To measure improvement in spinal injury patients, researchers use two yardsticks: the Upper Extremity Motor Scale, or UEMS, and the International Standards for Neurological Classification of Spinal Cord Injury, or ISNCSCI. On the UEMS scale,patients are scored from 0 to 5 on theirability to use five key muscles in the wrists, elbows and fingers. The ISNCSCI scale assesses where damage has occurred along the different levels of the cervical vertebrae, which generally determines the scope of impairment to the body and the level of care needed.

For instance, if a patient has sustained damage at the fourth cervical vertebra down, known as C-4, at the base of the neck, it generally means that person is paralyzed from the neck down, requiring round-the-clock care and a ventilator to breathe.A patient with a C-5 injury may not be able to move her arms or hands, requiring about 6 to 12 hours per day of assisted care; and at the C-6 level, better motor function mayallow a patient to take care of most of herdaily living needs on her own.

Which is all to say that even one level of recovery could substantially improve the daily life ofa spinal injury patient.

According to Asterias, all six patients in the 10million-cell cohort have improved their general UEMS scores, and jumped at least one motor level on the ISNCSCI scale on one or both sides of their body.

Two patients have improvedtwo motor levels on one side; and one patient,Boesen, has improved two motor levels on both sides.

Steve Cartt, president and CEO of Asterias, said anotherpatient, Jake Javier of Danville, California, has gonefrom partial paralysis to being able to use his hands well enough to considerpursuing a computer science career.

Throws Like a Regular Throw

In September, Boesens father, Rod Boesen, told us how excited he wasthat his son had regained some feeling in one of his feet. Last week, at11 months post-injection, the elder Boesensaid Kris has continued to improve.

Now he can move his toe and his knee together at the same time, Boesen said. Theyre about to give him a manual wheelchair now [instead of a motorized one]. He can grip with his hands enough to use a manual one.

Boesen said the movement in his sons arms and hands has greatlyimproved since September.Kris, a formerhigh school pitcher, had beenflinging a ball to his dog like people throw hand grenades, Boesen said. They kind of cradle them and thats how Kris would do it. But now he throws like a regular throw, tosses that ball down the hall, has that release point down, and just wings it.

Asterias is currently recruiting patients for a trial in which theyll receive 20 million stem cells, the optimal dose, according to company researchers. Two patients have already started the 20 million stem cell therapy, and six-month results from those patients will be released in the fall, Cartt said.

Patients who received 2 million stem cells in an earlier phase of the study have not shown much change in their condition, according to the Jan. 24 update.

Guarded Optimism

While Boesens father is impressed with the results, the optimism of researchers inside and outside the studyhas been guarded.The trial is still in its early stages, and the sample size is small, said Paul Knoepfler, a cell biology professor and stem cell researcher at UC Davis, who is not involved in the SCiStar study.

As a scientist, I still would want to wait for more data, Knoepfler said. Its certainly interesting, but its still early. Its a phase 2 trial.

To address the issue of small sample size, Asterias islooking at historical data to determinethe level of improvement for patients in similar circumstances who did not receive stem cell therapy. The company has said it found a meaningful difference in the recovery of its study patients compared to the norm.

Liu said one of the most importantresults is the lack of significant side effects or other negative outcomes resulting from the treatment to date.

Thats very significant to me, Liu said. Thats the first thing you look for, is anyone hurt from this therapy.

There was also a concern, he said, that some patients might regress over time, once the initial injection of stem cells wore off. Thathasyet to occur.

No one has lost anything theyve gained, Liu said. We were very happy to see that. This is all very promising.

The next step for the SCiStartrial will be to establish a control group, Cartt said.

More here:
Strong Progress for Paralyzed Patients After Stem Cell Therapy, Company Says - KQED

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Stem cell therapy is safe for stroke patients, study shows – Science Daily

Wednesday, March 22nd, 2017

Science Daily
Stem cell therapy is safe for stroke patients, study shows
Science Daily
A multicenter trial looking at whether a single dose of millions of adult, bone-marrow-derived stem cells can aid stroke recovery indicates it's safe and well-tolerated by patients but may not significantly improve their recovery within the first three ...
A Groundbreaking Stem Cell Treatment Just Prevented a Woman From Going BlindFuturism
Beware the hype on stem-cell breakthroughsThe Globe and Mail
Stem cells seem speedier in spacePhys.Org
American Council on Science and Health -PR Web (press release)
all 34 news articles »

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Stem cell therapy is safe for stroke patients, study shows - Science Daily

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