StemCell Therapy

Stem cells have been shown to do everything from regrowing skull bones to healing damaged lung tissue to repairing burned skin to fighting brain tumors and much more. They've even been used to restore vision in rabbits. But when three adult women tried an unproven stem-cell treatment at a clinic in Florida to combat vision loss from macular degeneration, they all went blind. A paper detailing the procedure and its tragic results was published today in The New England Journal of Medicine.

The paper was written by Jeffrey Goldberg, a professor of ophthalmology at Stanford University School of Medicine and Thomas Albini, an associate professor of clinical ophthalmology at the University of Miami where two of the three women were treated after complications from the surgery emerged. Goldberg says that the paper is a "call to awareness for patients, physicians and regulatory agencies of the risks of this kind of minimally regulated, patient-funded research."

The women who underwent the procedures aged 72-88 found the opportunity on the website ClinicalTrials.gov, a site where listings are not screened for scientific rigor according to Goldberg. Signing up through such a site gave the women the logical impression that they were going to be participating in a trial, however, Albini says it was anything but.

One warning sign should have been that the women each were made to pay $5000 for the procedures, when in legitimate clinical trials there are rarely fees. Another issue was that there was no mention of a clinical trial in the paperwork the women were asked to complete. The webpage for the study now reflects that it has been withdrawn and, according to the New York Times, the clinic is no longer performing the procedure.

"There's a lot of hope for stem cells, and these types of clinics appeal to patients desperate for care who hope that stem cells are going to be the answer, but in this case these women participated in a clinical enterprise that was off-the-charts dangerous," Albini said.

During the procedures, the women had fat removed from their abdomens. They also had blood taken. The fat was then processed with enzymes meant to isolate stem cells and the resulting material was mixed with plasma from the blood. That mixture was then injected into both eyes of all three patients which is another issue, according to Albini, who says that a cautious researcher would have just used one eye each to see how the procedure went before proceeding.

Because the treatment used biological material that came from the participants themselves, they did not require FDA approval.

Jeffrey Goldberg,MD, PhD, professor and chair of ophthalmology at the Stanford University School of Medicineand co-author of the paper(Credit: Norbert von der Groeben)

Now, one of the women has gone completely blind while two others are considered effectively blind, says a report from NPR. Two of the women have sued the clinic and settled, according to the Times.

Prior to the procedure, all of them were suffering from macular degeneration, a condition that leads to blurry vision and eventual vision loss. While their vision would have no doubt continued to degrade without the procedure, two were still able to see well enough to drive before the procedure. Albini says the complications could have come from injecting a contaminant into the eye, or from the fact that the stem cells may have turned into myofibroblasts after the injections, which are cells associated with scarring.

Proving that stem cell treatments can also be perfectly sound, The New England Journal of Medicine also published a paper today that details a Japanese study that used a type of stem cells known as induced pluripotent stem cells (iPS) to treat a subject suffering from macular degeneration. A year later, the patient suffered none of the additional vision loss that would be common with the condition. iPS stem cells have a body of research behind their potential healing abilities, while the fat-based cells used in the procedures do not.

Adding to the flurry of activity regarding stem cells in today's New England Journal of Medicine, was an editorial by leading stem-cell research and dean of Harvard Medical School, George Q. Daley, as well as a piece by a team of researchers entitled "Clarifying Stem-Cell Therapy's Benefits and Risks." Both call for stricter regulation of the stem-cell industry and holding those who operate in that arena accountable to the same rigorous research standards applicable to all scientific advances.

Until then, Albini advises that individuals thinking about stem-cell treatments check out a website called A Closer Look at Stem Cells, while also investigating whether the person proposing to do the treatment is associated with an academic medical center.

"We expect health care providers to take every precaution to ensure patient safety, but this definitely shows that the lack of oversight can lead to bad players and bad outcomes. It's alarming," Albini said.

Link:
Blindness strikes three women after iffy stem-cell treatments - New Atlas

A child is screened for trachoma. The gap in rates of blindness between non-Indigenous and Indigenous Australians has halved since 2008. Photograph: University of Melbourne/AAP

The gap in rates of blindness between non-Indigenous and Indigenous people has halved since 2008, a world-leading ophthalmologist, Prof Hugh Taylor, told a Closing the Gap conference in Melbourne on Thursday.

In 2006 rates of blindness were six times higher for Indigenous people. By 2016 this had dropped across Australia to being three times higher. Taylor said it was an example of how cheap and basic public health measures, such as providing clean water and hygiene, can have a dramatic effect on health.

Thats still a terribly high gap but we have made a lot of progress, said Taylor, from the University of Melbournes Indigenous eye health group.

We think that there has been a significant increase in commonwealth recognition of this problem but we think there is $10m more a year more needed to completely close the vision gap by our target of 2020.

Australia is the only developed country where trachoma is still prevalent and this burden of disease is suffered exclusively in Aboriginal and Torres Strait Islander communities. The disease was eliminated from mainstream Australia through improved sanitation about 150 years ago. Ten low- or middle-income countries have managed to completely eradicate trachoma before Australia.

The painful disease is caused by the bacterium Chlamydia trachomatis and, left untreated, it causes blindness. An infectious disease, it spreads easily, especially between children. Other key causes of blindness and eye disease in Aboriginal and Torres Strait islander people are cataracts, diabetes and eye conditions that have not been corrected with glasses.

Simply spreading the message of face and hand washing, and ensuring that Indigenous people had access to clean bathrooms, had gone a long way towards preventing the disease, Taylor said.

He is now pushing the commonwealth government to provide funding so his team can collect more data and identify where rates of eye disease are high and interventions such as antibiotics, improved living conditions and sanitation are needed. This data would be essential to closing the gap in eye health by 2020, he said.

On Thursday, the Closing the Gap steering committee released a report that found that the federal government had failed to listen or act adequately or appropriately to improve health and social outcomes for Aboriginal people. The report found across nearly every government-funded program, interventions were imposed and often rushed.

Darryl Wright, the chief executive of Tharawal (Campbelltown) Aboriginal Medical Service, said interventions to close the gap in health outcomes for Aboriginal and Torres Strait Islander people had to be led by Aboriginal community-controlled health organisations.

His is one of seven such organisations in New South Wales to have partnered with the Sax Institute in Sydneys Search program, a long-term study of the health and wellbeing of urban Aboriginal Children.

One of Searchs flagship programs is the Hearing, Ear Health and Language Services (Heals) project, which treats Indigenous children who experience middle-ear disease. They suffer from ear diseases earlier, more often and with more complications than non-Indigenous children.

Left untreated it can lead to hearing loss, speech and language delays, and can significantly impact on schooling, ultimately causing difficulties in accessing higher education and employment. Most Aboriginal children in the youth justice system have untreated ear disease.

Wright said since partnering with Heals, more than 100 children in the region had received free surgery. Hundreds more had received treatment for associated conditions such as speech impediments.

We go into schools and give kids hearing tests, and if problems are found we encourage them to come to the medical service for treatment, he said.

The results are amazing. You can see the result from the kids eyes and their faces. They can hear properly, they can pronounce words properly, and the doctors and speech therapists just love their work because they can see the difference they are making.

We have heard so many stories of teachers and parents thinking these kids are lazy at school but in fact they had untreated hearing problems that were affecting their behaviour and education.

Since 2013 more than 7,000 speech and language sessions and ear, nose and throat surgeries have been delivered in NSW as part of Heals.

This type of program should be available to everyone with an Aboriginal background in Australia

Dr Hasantha Gunasekera, the Heals program manager and a doctor at The Childrens Hospital at Westmead, said despite the programs proven success, funding from the NSW government needed to be secured every year.

He said the interventions were relatively cheap but saved significant costs in the long run. Its great that NSW has provided funding so far, but one-off funding is not the best way to do this, Gunasekera said.

What we need is recurrent funding so we can plan services across the year and expand so that screening and treatment is not just available to those areas where we have research partnerships.

I would argue that this type of program should be available to everyone with an Aboriginal background in Australia.

The key to the programs success had been the leadership shown by Aboriginal community-controlled health organisations, he said.

They organise appointments, arrange access to schools and appointments with therapists, they talk to families, he said. Its another example of where this can work can be a good news story for Aboriginal people if everyone works together.

Original post:
Gap in Indigenous blindness rates halved in nine years, expert says - The Guardian

In the United States, roughly 10% of all infants are born prematurely. And while premature infants face a number of health problems in their first few weeks, one of the most devastating and preventable illness is a condition called Retinopathy of Prematurity. This is a condition that can cause permanent blindness in infants, and it is also one that an attentive medical staff can prevent.

Mike Papantonio is joined by attorney Virginia Buchanan to explain why this is happening and what you need to know to keep your newborn safe.

For more information on Retinopathy of Prematurity Medical Errors, visit Infant Blindness Malpractice

Transcript of the above video:

Papantonio: The Centers for Disease Control tell us that one out of every ten babies born in the United States is born prematurely. And while premature births steadily decreased between 2007 and 2014, 2015 saw a slight increase in the number of babies born early. Thats the most recent year of full data.

Doctors currently dont have an answer as to why the number of pre-term births are rising, but they are well aware of the difficulties and health problems that pre-term infants go through.

In order to help pre-term infants survive, they are often placed on breathing machines, supplied with feeding tubes, given medications, and kept in incubation until they are able to survive without the help of doctors and nurses. But even with all of these precautions, problems still persist, and some of those problems can actually be made worse by these measures.

One of those problems is Retinopathy of Prematurity, a condition that has become common in pre-term infants with low birth weights. This condition is an eye disease that typically is corrected and results in no long term health effects for the child. But each year, more than 1,200 severe cases of Retinopathy occur. These severe cases can result in the complete detachment of the retina or blindness, and as many as 500 newborn infants go blind as a result.

Retinopathy of Prematurity is responsible for 15% of all childhood blindness cases in developed countries, and it is responsible for as much as 60% of cases of blindness in children in middle income countries. Whats worse is that this disease can be prevented and treated if caught early enough, but that requires attentive care from doctors, nurses, and pediatricians. And a caregiver that doesnt pay attention to the warning signs can cause a child to go their entire life without the ability to see.

What happens with this disease is that the blood vessels in the eyes dont develop properly, a condition that can be easily detected with standard medical equipment. Once the pre-term child has been born, these under-developed blood vessels can begin leaking blood into the eye, resulting in scarring that leads to partial or complete detachment of the retina.

Again, caregivers are well aware of the signs and symptoms of this disease, and simple tests can be performed to determine if a pre-term child is at risk. But a negligent caregiver that ignores the warning signs or simply fails to perform the necessary tests or refer the family to a specialist can doom a child to a life of hardship, surgeries, and possible blindness.

Papantonio: Joining me now to explain the risk of this disease and how negligent caregivers play a role in childhood blindness is attorney Virginia Buchanan whos represented the families of infants whove suffered from retinopathy of prematurity. Virginia, first explain exactly what this disease does and how it can cause blindness in preterm infants. How does it work?

Virginia: Yes, Michael, as you were saying, this is a worldwide problem and its one that affects about 15,000 infants in this country each year. There are a large number of premature infants and out of those, the 15,000 who have it, most recover fully, as you say, but about 1,200 of them have very severe retinopathy of prematurity. What that means is that thin liner behind the eye that serves to reflect light and that plays a key role in vision, becomes scarred and causing the retina to detach. The retina has the thickness of, like a saran wrap, a clear plastic wrap, and it has the strength of wet tissue. Therefore, it is very vulnerable any its very susceptible to injury. When these blood vessels scar by rupturing and pulling, the retina detaches resulting in visual loss.

What we encourage the American Academy of Pediatrics, all of the professional ophthalmology organizations encourage serial examinations of preterm babies. Particularly those infants who are under 31 weeks and under three pounds, theyre encouraged to have serial exams because all you can tell initially is that the baby has abnormal blood vessels. Typically, you dont see detachment immediately.

Papantonio: Virginia, let me ask you this, how does negligence or substandard care factor into the prevalence of this problem? When we analyze everything, this condition, what are the caregivers doing or what are the not doing that cause this to be a bigger problem than it should be? How does it progress in some infants?

Virginia: Yeah, thats an excellent question. Because, when you look at those 1,200 that we are saying who have very severe untreated retinopathy of prematurity, and you compare them to the other premature, very low birth weight babies, some being blind, some not, what we see is those who are able to recover from the condition have these serial assessments by ophthalmologist who are trained to look for these abnormal blood vessels and to administer treatment. There are a series of things that can be done and those babies who go on to have, maybe some visual impairment, they might need glasses, but they have good vision, theyre able to be fully functional, they have those serial assessments. They go, and really beginning just a few weeks after birth, they start having these assessments.

The frequency of them depends upon the amount of abnormalities seen at each successive exam, but for example, a stage 1 and early retinopathy of prematurity still has to be followed because it can progress. Even as a child goes on and matures over time, and the eye grows, and the body grows, the retina can detach even beyond that immediate timeframe where the infant is truly still premature.

Papantonio: I know you get calls on this. Youre a specialist in medical malpractice, and youre seeing more of these calls, and Im wondering what do medical professionals, if you had the chance to give a speech to medical professionals who are very well trained in this kind of care, what is it that you would tell them that they can maybe improve to detect this disease that maybe United States hospitals need to be doing? What tools are needed to detect this problem? How do we improve the system?

Virginia: We do it by what weve recognized for 75 years since the first study was done, these babies can be put under just an ophthalmoscope. The blood vessels can be appreciated as being abnormal and they have to have serial examinations. Its very simple. This is not undergo a great surgery, bringing in all the worlds specialists, this is something that any pediatric ophthalmologist can do, and every pediatrician, every primary care doctor who sees a baby with a history of being premature or low birth weight should be immediately sent for screening. Thats what the American Academy of Pediatrics has long recommended. Weve had treatment for at least 30 years and those treatments continue to be honed and improved. Its something that should be done.

This is one of those very sad, preventable outcomes, which as you said, is devastating. For an infant to exist with very low visual acuity or no visual acuity at all is a tragedy. It ends up really costing society, more than just for that child, it affects everyone when we have these children needlessly blinded because of not getting the examinations and the treatment that they should be getting. Its well within our reach.

Papantonio: Virginia, theres checklists. In other words, every doctor or caregiver is confronted with: These are the things we do when we have a preemie. This is the thing we need to do when this occurs. This is one of those things on that checklist that are there, but it has to be followed. Where would you put it in that checklist, just in your experience having to handle so many cases, where would you put it in that checklist? In the top five? In the top three? Where would it go?

Virginia: Oh, it would be right after those first well-care items where we check the babys height, and length, and head circumference, where were looking for very severe anomalies that need to be treated. This is one of those. It falls right under it. It really has to be a priority to every physician who takes care of a pediatric patient to get that prior history, whether the baby moves away, or grows, or the doctor changes, whatever happens, that they have a complete and accurate history of the prematurity or the low birth weight, so they know, their sense should be heightened to that risk existing in that child, and that they send the baby out for assessments. My own child has a coloboma and has to see a pediatric ophthalmologist. They also should.

Papantonio: One thing I read though is that mothers arent, theres all types of things that mothers learn when theyre getting ready to give birth to a child. This isnt something thats really built well into that, that mothers should know more about to where they can take self-help measures to say, Doc, I know youre doing your job, but gee wiz, did you check this out? Isnt that the kind of thing, dont you find sometimes that the patients are too slow to ask the doctor and say to the doctor, What about this? In this situation, dont you think the mother has to know and this has to be talked about prior to the time of the birth? Whats your take on that?

Virginia: Absolutely. I agree. You can be the very best advocate for your child and yourself. We all encourage, certainly in the work that I do, that we as consumers have to be proactive. We should ask those questions. Things get missed, we get shuffled about, we deal with other people taking a history, and the doctor doesnt appreciate the problem, and we certainly should ask, and we should keep asking because this is not a one time assessment. Once youre born prematurely, you have to have serial evaluations done.

Papantonio: Yeah, let me close with this. I know youve given speeches on this. Patients have to ask questions of their doctor. Sometimes theyre afraid to do that. Theres this notion in our culture that the doctor knows everything. Well, a patient has to take some self-help measures, this is one of them. Virginia, thank you for joining me. I appreciate it.

Virginia: Thank you.

See original here:
Medical Negligence Leads To Blindness In Infants - America's ... - The Ring of Fire Network

The Virginia Department for the Blind and Vision Impaired celebrates the graduation of Angelica Rios from the American Massage & Bodywork Institute on Friday, March 17.Angelica has had an incredible journey from her birth in Peru to graduation day. At the age of 27, Rios was a victim of a terrorist attack that claimed the life of her son and caused major physical injury to herself, including the loss of vision.

Through the years that followed, Angelica continued to live and raise a family. It wasnt until 2016 that she chose to chase her dream of independence and a career of her own. She reached out to the American Massage & Bodywork Institute and spoke with Scott Deidun, Co-owner, President, and CEO about the type of support she could receive. Upon meeting Angelica, she told me about her history, and it made me want to help her more and more. Having a disabled niece, I knew that all you want is for people to treat you normally and to give you a chance. Angelica told me that she wanted to be more independent, and to be able to provide for herself, but that the only job she has had in the states was folding silverware in cloth napkins at a restaurant for minimum wage, stated Deidun. In front of me was a person on a mission for a better life because she knew she was capable of more. English wasnt Angelicas first language, and she cant see anything, but her heart is as big as a basketball, and she had such a strong desire to help others, and be a role model for the visually impaired community.

After their meeting, Deidun contacted the Virginia Department for the Blind and Vision Impaired to find out what support could be provided to Rios within their program. Through their collaboration, Rios is graduating from the 7-month program to become a licensed massage therapist in the Northern Virginia area. The ceremony will be held from 3:00 p.m. to 5:00 p.m. on March 17at the American Massage & Bodywork Institute, 1593 Spring Hill Rd, Suite 210 (East Concourse), Vienna, VA 22182.

The Virginia Department for the Blind and Vision Impaired is committed to provide quality services to assist Virginians who are blind, deafblind or vision impaired in achieving their maximum level of employment, education, and personal independence. The department provides an array of specialized services to blind and visually impaired Virginians of all ages to assist them in attaining the skills, confidence and positive outlook that are critical to independence.

More here:
Reaching Goals With Blindness - Alexandrianews.org

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NAS Issues Report on Preparing for Future Products of Biotechnology - JD Supra (press release)

GRAND ISLAND When she gets home after basketball practice, Hayley Henke appreciates the chance to soak in the familys hot tub. The fact that the hot tub is outside doesnt bother her, even when the weather is cold.

The hot water brings relief to her knees.

Henke, 13, has juvenile rheumatoid arthritis, which causes joint inflammation and stiffness.

Henke returned to Nebraska earlier this month from Washington, D.C., where she was one of two Nebraska representatives at the Arthritis Foundation Advocacy Summit.

For Henke, the discomfort is worse when she gets up in the morning or after shes been active. An eighth-grader at Central Catholic school in Grand Island, she takes part in volleyball, basketball and track.

The arthritis bothers her fingers, ankles, toes and wrists, but the greatest pain is in her knees.

After shes been running a while, she sometimes has to take a break at practice. Last year, she ran the 400 meters in track, but this spring she will concentrate on the 100- and 200-meter dashes, because the longer distances are harder on her knees.

Henke was diagnosed with arthritis when she was in first grade. The pain was so bad that Henke would sometimes curl up in her mothers lap.

Henke has undergone 10 knee surgeries. During those procedures, a doctor scopes the knee to assess damage to the joints, drains the fluid and injects steroids.

Both of her knees will have to be replaced before she turns 18.

Henke was one of about 45 people who spoke at the Capitol this month to an audience that included members of Congress. She also met with Sen. Deb Fischer (R-Neb.) and people who work on medical issues for Sen. Ben Sasse and Rep. Adrian Smith.

Henke urged the Nebraskans to join the Congressional Arthritis Caucus. Nebraska is one of five states not represented in that group. The health representative from Smiths office seemed especially interested in her information, Henke said.

In her talks, Henke told her story and reminded people that children and teenagers can be victims of arthritis.

Stephanie Henke appreciates her daughters strength. Its been fun to watch her grow and be able to speak to the groups in Washington, she said.

As a Junior Platinum Ambassador for the Arthritis Foundation, Henke is given a monthly task to call attention to arthritis.

Every Sunday, Stephanie injects a medicine called methotrexate into her daughters thigh. That drug prevents joint damage.

After each one of her knee surgeries, she needs crutches or a wheelchair to get around for about a week.

When she wakes up each morning, she knows if the weather is about to change. She feels stiffness or pain in her joints.

Because rheumatoid arthritis is an autoimmune disease, regular illnesses take a greater toll on Henke.

She ended up in the hospital last year for just a common flu, her mom said. That hospital stay lasted five or six days.

Henke is also partially blind in one of her eyes from the arthritis.

Because of the support of local Shriners, Henke receives medical care at Shriners Hospitals for Children in Minneapolis.

She also sees a childrens rheumatologist twice a year in Omaha.

Link:
13-year-old with juvenile rheumatoid arthritis visits DC - Omaha World-Herald

Rheumatoid arthritis (RA) is a particularly nasty form of arthritis. While the more common form of arthritis osteoarthritis typically results from use and overuse of joints which wear down protective cartilage, RA is known to result from autoimmunity. The immune system is misdirected to attack the lining of joints, causing swelling, severe pain, and if not treatedjoint destruction. Not only the joints are affected, however. RA involves an inflammatory process that can affect many body organs, including the skin, heart, lungs and bone marrow. For example, it's known that RA sufferers have a higher risk of developing osteoporosis.

Of course, just because autoimmunity is involved doesn't mean that external factors can't or don't play an important role in instigating the disease. And recent research published in Science Translational Medicine suggests how good dental care might well be an important factor in preventing the onset of RA.

The investigators, led by Dr. Maximilian Koenig from the Johns Hopkins University School of Medicine, explained that mucosal surfaces such as those of the gums, lungs and GI tract have long been suspected as possible sites of RA initiation. In fact in the early part of the 20th century, pulling all a patient's teeth was thought to be a means of treating RA it didn't work, though.

This recent study investigated the possibility that a bacterium associated with periodontal disease Aggregatibacter actinomycetemcomitans (Aa) could be the initiator of the autoimmune feature of RA. The investigators noted that Aa, of all the other identified microbes, was the only one known that could produce the spectrum of antigens found in the joints of individuals with RA.

To investigate this possibility, they collected fluid from the gum regions ofpeople with periodontal disease and from those of controls and analyzed them for the presence of altered proteins those which had been "citrullinated"1 which are known to be immune system targets.Further, they identifieda pore-forming toxin, leukotoxin A (LtxA) produced by Aa which triggers the production of the citrullinated proteins.And the immune system will make antibodies to such proteins the autoantibodies.They determined that62 percent of individuals with periodontitis had antibodies to LtxA, compared to only 11 percent of controls without periodontal disease (a statistically significant difference). Also, these antibodies were significantly enriched in patients with RA compared to healthy patients without periodontitis.

In sum, people with periodontitis are more likely to have the Aa bacterial toxin and thus more likely to produce targets (citrullinated proteins) for the immune system. This in turn, links periodontal disease and rheumatoid arthritis.

While these data are certainly not the last word in RA initiation, they are reasonable evidence that the disease can be triggered by the products of this particular bacterium, and could provide a means of identifying those at risk of developing the condition. At the very least, they underline the importance of good dental hygiene and health.

1. A citrullinated protein is one in which the amino acid arginine is converted to the amino acid citrulline. This change affects the way the protein folds and functions.

See more here:
Brush and Floss to Prevent Rheumatoid Arthritis - American Council on Science and Health

March 14, 2017

Arthritis diagnoses are at an all-time high in the United States, affecting 54 million adults, Anne Schuchat, M.D., acting director of the Centers for Disease Control and Prevention, said at a recent press conference. And that number is expected to grow to 78 million adults by 2040, she added.

The March 7 media event was held in conjunction with the release of a new Vital Signs report about the condition, which the CDC produced by analyzing data from the National Health Interview Survey.

In addition to the sheer numbers, Schuchat said she found alarming the number of people who are limited by the condition. Twenty-four million people with arthritis now have trouble doing things such as kneeling on the ground, holding a cup, lifting a grocery bag or walking to the car, she said.

Among adults with arthritis, the percentage whose lives are particularly limited has increased by about 20% since 2002, from about 36% in 2002 to 43% in 2015,she said.

Schuchat recommended that physicians and other professional caregivers encourage older adults to exercise and attend disease management programs, where they can learn to reduce their symptoms by 10 to 20%.

Physical activity can decrease pain and improve function by almost 40%, she said, but only about one-third of adults with arthritis report being active.

In the past, people with arthritis may have been told not to be active in fear of making their arthritis worse, Schuchat said. It's now proven that being physically active can be helpful, and there are ways to be active that can accommodate physical limitations from arthritis.

Schuchat suggested that older adults with arthritis try walking, biking, swimming or participating in other exercise, starting slowly and building up to longer periods of activity.

Exercise also presents an alternative to the opioids that some adults with arthritis may be prescribed for pain, aching, stiffness and swelling of the joints, Schuchat said. It also can help with depression and other chronic diseases, including heart disease and diabetes, that have been linked to the condition, she said.

Read the original post:
Arthritis is at an all-time high, CDC says - McKnight's Senior Living - McKnight's Senior Living

Fresh off a third-place finish in the 2017 Burton U.S. Open slopestyle competition, Olympian and five-time X Games medalist Spencer OBrien is arguably one of the sports most progressive and talented riders. But thats the stuff of headlines.

Behind the scenes, the Canadian, 29, has fought her way through painful rheumatoid arthritis since a 2013 diagnosis, just two months before the Sochi Winter Olympics.

The year before OBriens genetic condition was identified was torture. Advancing swelling and stiffness made it nearly impossible to get out of bed, let alone launch off of a lofty, icy slopestyle feature.

I was like an 80-year-old woman, but I was only 25, OBrien told GrindTV. Id go to the gym and have morning stiffness for five hours. It was mind-blowing that I let it go on that long.

But it wasnt surprising. Onset of her arthritis was slow, it often presented as injury and no one in OBriens immediate family had it. It was hard to diagnose.

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In the morning I would have creaky, achy knees, but it would subside. You adapt to it, she says. I thought I was just getting older. I do an impact sport, so I thought it was normal aches and pains. You get blinded by the pain.

In fact, the arthritic inflammation of OBriens joints was especially awful in her shoulders. By Olympic trials time, she couldnt lift her arms over her head. There were cortisone shots, a progressing cyst in her knee and scary joint inflammation in her toes.

Id have to prep myself to lift my head off the pillow, she says. Putting my feet on the ground was so hard.

From trauma to treatment Once doctors finally nailed the issue, OBrien was exhausted mentally and physically. Amazingly, she has continued to compete as shes dialed in medical treatment over the years.

Now she injects a refrigerated shot in her thigh once a month for prolonged relief. While the immune suppressant helps ward off the bodys inflammatory response, it also makes OBrien more susceptible to infection, which means she can get sick easily.

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Even small cuts, if they were to infect the blood or bones, could be deadly.

Im a young woman, so I dont want to be on this injection forever, OBrien says. But for now, its working. Theres more hope: Rheumatoid arthritis can go into remission. However, the trade-off is going off the medicine, and OBrien is not ready to test that just yet.

An elimination diet is another alternative something shes researching. But first theres more snowboarding to prepare for, which, for OBrien, includes extensive dryland training more than most in her sport will do.

Im focused on the [2018 PyeongChang, South Korea] Olympics now. It would be amazing to go again for Canada, says OBrien, who, newly diagnosed at Sochi, didnt even make it to the opening and closing ceremonies.

I finally feel my age again, OBrien says, like a fully able-bodied person.

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Pro snowboarder Spencer O'Brien overcomes odds of early arthritis - GrindTV

Despite the fact that millions of Australians are affected by arthritis, theres still much we dont know about the condition.

While we know sufferers often suffersevere pain and even disfigurement, there are still unanswered questions that have left many in the dark about living with arthritis, as well as the possibility of a cure.

This is no small issue: almost 4million Australians live with arthritis a number thats expected to blow out to 7 million by 2050 and another 6.3 million have low bone density, a related condition.

Now, a public seminar offers peoplerare opportunity to ask doctors and arthritis experts questions about the condition and have them answered in a thorough, thoughtful way.

In a bid to open up theconversation about the common but poorly understood condition, the Queensland University of Technology is hosting a public seminar on Saturday 18 March, where anyone can come along and listen to experts talk about the latest innovations in this area. The seminar, which is part of of QUTs Real World Health series, will be held in Brisbane and broadcast live online so people around the country can tune in and take part.

Themost pressing issues in arthritis research is the need to develop an early-diagnosis test, and to find acure for the condition. Professor Yin Xiao from the QUT Institute of Health and Biomedical Innovation is working on just that.

At present theres no single test which will early diagnose or a drug that cure osteoarthritis, he told Starts at 60. In particular, our research interests include identifying risk factors of osteoarthritis, evaluating new ways of early diagnostics through improved imaging methods, and working towards designing and testing new treatments that help to repair osteoarthritis joints.

At the seminar, speakers will be addressing key questions, including:

The experts will openthe floor to the public to pose questions, and those who cant attend in person canemail questions through ahead of time thenwatch the seminar via a live stream online from home.

If youd like to submit a question about arthritis, you can do by emailing [emailprotected] before Saturday.

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Unique opportunity to get your arthritis worries addressed - Starts at 60

Newser

3 Women Blinded After Stem Cell Therapy Newser CORRECTS FROM MD ANDERSON HOSPITAL TO MD ANDERSON CANCER CENTER -Senior Clinical Cell Therapy Specialist Megan Raggio prepares stem cells from bone marrow before they are transplanted into sportscaster... (AP Photo/David J. Phillip). One stem cell treatment stabilizes macular degeneration, another blinds 3 patientsCNN Doctors say stem cell treatment at clinic blinded 3 womenWABC-TV Three women blinded after stem cell injections at Broward clinicMiami Herald Science Magazine -NPR -Stanford Medical Center Report -The New England Journal of Medicine all 126 news articles »

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3 Women Blinded After Stem Cell Therapy - Newser

Runner's World

Stem Cell Therapy | Runner's World Runner's World They're harvested and then injected into an injured area to stimulate tissue healing. Has stem cell therapy helped the Boden's poster girl say her first words? Cerebral palsy patient Holly, 11, shows ...Daily Mail $145.8 Million Stem Cell Therapy Market by Type, Therapeutic Application, Cell Source - Global Forecasts to 2021 ...Yahoo Finance 'Stem cell treatment can cure blood platelet problems'Daijiworld.com UroToday -Medgadget (blog) all 19 news articles »

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Stem Cell Therapy | Runner's World - Runner's World

TiGenix announces positiveone-year results forits phase I/II trial of donor-derived cardiac stem cell therapy in acute myocardial infarction (AMI).

The Belgian biotech TiGenixis developing allogeneic stem cell therapies. Now the companyhasannouncedthat its cardiac stem cell therapyAlloCSC-01 reached its primary endpoints in aphase I/IItrial.

In 2015, the companyacquired Coretherapixin a292M deal for its allogeneic cardiac stem cell pipeline, which is being developed for the treatment of AMI.The first-in-human trial was designed to test the safety and feasibility of an intracoronary infusion of donor-derivedexpanded cardiac stem cells (AlloCSCs)in patients with AMI and left ventricular dysfunction.

AlloCSC-01consists of adult allogeneic cardiac stem cells isolated from the heartof donors and expanded in vitro. In vivo studies suggest that these cellshave cardio-reparative potential by activating regenerative pathways and promoting the formation of new hearttissue.

Thecurrent phase II study demonstrated thesafety of these allogeneic stem cells. Initial results also revealed a larger reduction of infarct size in a subgroup of patients.

Myocardial infarction caused by blockade of coronary arteries

TiGenix is well known forChondroCellect, which was the first cell therapyto reach the European market for the repair of knee cartilage.After the companyrecently withdrew its market authorization for this product, due to a lack of reimbursement, the biotech is focusing on another stem cell therapy, Cx601, in addition to AlloCSC-01. Under development for Crohns disease, Cx601 is currently awaitingEMA approval and is in phase III trials in the US.

For a late-stage clinical company, TiGenix has a low market cap of191M. Even so, the company seems to be doing well these days with the progress of Cx601 and AlloCSC-01.

If AlloCSC-01 obtains market approval, it could treat the more than 1.9 millionpeople affected by AMI, a major cause of heart failure. So far, most treatments are palliative or restore myocardial function by angioplasty and insertion of a stent to support the vascular lumen.

Stem cell therapy of the heart is definitely not a new topic, but many trials have been conducted using the patients own stem cells derived from the bone marrow. A recent meta-analysisof such trials has suggested that these therapies are safe, but do not enhance cardiac function. TiGenixs approach using allogeneic heart-derived stem cells may offer a new and promisingopportunity in thefield.

Images via shutterstock.com / Liya Graphics andVeronika Zakharova

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New Cardiac Stem Cell Therapy passes Phase I/II Trials - Labiotech.eu (blog)

The women, aged between 72 and 88, were treated in Florida in 2015 for a progressive eye disease called macular degeneration, said the report in the New England Journal of Medicine.

They thought they were enrolling in a legitimate clinical trial, having found it under the title: "Study to assess the safety and effects of cells injected intravitreal in dry macular degeneration" on ClinicalTrials.gov, the US government website for such research.

However, they immediately suffered complications, including retinal detachment and hemorrhage, which caused total loss of eyesight.

The clinic and patients involved were not named in the study, which was co-authored by Thomas Albini, associate professor of clinical ophthalmology at the University of Miami.

Two of the patients sought treatment at the university's hospital for the complications they suffered.

"There's a lot of hope for stem cells, and these types of clinics appeal to patients desperate for care who hope that stem cells are going to be the answer," said Albini.

"But in this case these women participated in a clinical enterprise that was off-the-charts dangerous."

The procedure claimed to use adipose-derived stem cells to restore vision.

Patients had fat cells removed from their abdomens. This fat tissue was processed with enzymes in order to get stem cells, which would be mixed with platelet-dense plasma and injected into their eyes.

Albini said the complications could have been caused by contamination during the mixing process, or the stem cells, once injected into the eye, could have changed into a type of cell that led to scarring.

Whatever happened, experts said there was no evidence to suggest the procedure would have helped restore vision, since so little study has been done on whether adipose-derived stem cells can mature into the kinds of retinal cells that are involved in macular degeneration.

"Reading this article gives me chills down my spine," said Nazanin Barzideh, chief of vitreoretinal surgery at Winthrop University Hospital in Mineola, New York, who was not involved in the study.

"There were so many red flags," she told AFP.

Among them, the patients received injections in both eyes at the same time, when more responsible physicians would have tried one first to see how the patient reacted to the procedure before doing the other eye.

"You do not do a bilateral injection in the same setting," she said.

Also, the patients were asked to pay $5,000 each for the procedure, which is a signal of fraud since clinical trials do not charge patients to participate.

"There is also no basic evidence for this trial," she said, urging patients to always seek a second opinion from a medical professional before agreeing to any therapy.

Another outside expert, Sung Chul Park, director of the Glaucoma Clinic at Manhattan Eye, Ear and Throat Hospital, agreed.

"These cases emphasize the importance of evidence-based medicine in patient care," he said.

Co-author Jeffrey Goldberg, professor and chair of ophthalmology at the Stanford University School of Medicine, described the report as a "call to awareness for patients, physicians and regulatory agencies of the risks of this kind of minimally regulated, patient-funded research."

The US Food and Drug Administration has since released more specific guidelines requiring regulatory oversight and approval for these types of procedures.

Clinical trials can be confusing, so Goldberg recommended patients search online for "A Closer Look at Stem Cells," by the International Society for Stem Cell Research, for more information.

"Although numerous stem cell therapies for medical disorders are being investigated at research institutions with appropriate regulatory oversight, many stem cell clinics are treating patients with little oversight and with no proof of efficacy," said the study.

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Unproven stem cell therapy causes three women to go blind - Times LIVE

Lixia Guo / BuzzFeed News

ID: 10708849

Elizabeth Noble enjoyed a full and active life, and is nobodys fool. For more than a quarter-century, she taught statistics in the School of Education at the University of Missouri-Kansas City. In retirement, she continued to work as a consultant, and travelled widely in Europe and Asia.

When Noble was diagnosed with Age-Related Macular Degeneration, which slowly blurs the sharp central vision that we rely on to read, drive, and identify faces, she wanted to do something about it. And she thought she had found an answer a research study described on ClinicalTrials.gov, a website run by the National Institutes of Health (NIH), the US governments premier biomedical research agency.

It seemed scientifically legitimate, so in June 2015 Noble went to a clinic in Sunrise, Florida, where staff sucked a small quantity of fat from around her belly button, treated it with enzymes to extract the cells it contained, and mixed those cells with a sample of Nobles blood plasma. They injected the mixture into Nobles eyeballs, charged her $5,000, and told her to avoid strenuous activity for the next three days.

US Stem Cell Clinics office in Sunrise, Florida. Google Street View

ID: 10705938

Three days later, when the 72-year-old was seen by doctors at the University of Miamis Bascom Palmer Eye Institute, strenuous activity was out of the question. Nobles eyes hurt and she was nauseous. Her retinas were bleeding and she could just make out a hand being waved in front of her face.

Nobles sight continued to deteriorate and one year later she couldnt tell the difference between night and day. Thats as bad as it gets, Thomas Albini, an ophthalmologist at the Bascom Palmer Eye Institute, told BuzzFeed News, describing the condition of the woman he identified only as Patient 1.

In the latest issue of the New England Journal of Medicine, Albini and his colleagues describe the cases of three women treated by the same stem cell company, each of whom became legally blind. The doctors dont name the women involved, but BuzzFeed News established the identities of two of them from court filings and other public documents.

This isnt the first time that people have been harmed by clinics offering unproven treatments purportedly involving stem cells. In 2010, for example, a woman with the autoimmune disease lupus died after her own bone marrow cells were injected into her kidneys at a clinic in Thailand. And in 2013, the Florida Department of Health revoked the medical license of Zannos Grekos over the death of a 69-year-old woman. He had extracted material from her bone marrow, filtered it, and then infused it into the arteries feeding her brain. The woman had a stroke, and died shortly afterwards.

But the latest tragic cautionary tale has a disturbing twist, as two of the women who were blinded contacted the company involved, now called US Stem Cells but formerly known as Bioheart, only after reading about its macular degeneration study on ClinicalTrials.gov.

The site was launched in 2000 after Congress passed a law demanding that the NIH keep a registry of clinical trials experiments with new drugs on volunteer patients so that drug companies couldnt sweep negative results under the carpet. ClinicalTrials.gov has since grown to include some 290,000 studies run in countries across the globe.

But with only minimal screening of the listings, experts who track the burgeoning and loosely regulated landscape of stem cell clinics fear that the website is being abused to claim spurious legitimacy for unproven therapies that are being sold for profit.

Its very easy to register studies on ClinicalTrials.gov and essentially use a government website as a marketing device, Leigh Turner, a bioethicist at the University of Minnesota, told BuzzFeed News.

Noble told the doctors at the Bascom Palmer Eye Institute that she thought her treatment was part of a clinical trial. Patients are not usually charged to take part in research. Yet each of the three women described in the case reports were charged $5,000, and Albini said that the consent paperwork made no mention of a study.

I think it was presented as a clinical trial and documented as a fee-for-service procedure, Albini said. In September 2015, shortly after the three women were treated, the ClinicalTrials.gov listing was amended to say the study had been withdrawn prior to enrollment.

Before that change was made, it is easy to see why Noble and Patsy Bade, who also decided to seek treatment after finding the ClinicalTrials.gov listing, might have found it convincing. It includes an long list of conditions that could exclude people from participating, and indicates that patients would be studied 6 months after their treatment, to record their field of view and the sharpness of their vision.

Neither Noble nor Bade had severe sight loss before their eyeballs were injected with material extracted from their abdominal fat. Noble still had 20/30 vision in her left eye, which is barely different from normal. Its good enough to read newspaper print, Albini said. Its very functional vision. Bade, who was 78 when she was treated and lives in Venice, Florida, struggled to read fine print and had problems driving at night. But otherwise, she could function normally.

The back of Patsy Bades left eye after the stem cell treatment. Dark patches show bleeding in the retina. Thomas Albini

ID: 10705950

These ladies who were both independent were rendered blind, their attorney, Andrew Yaffa of Grossman Roth Yaffa Cohen in Coral Gables, Florida, told BuzzFeed News. The women sued US Stem Cell, the affiliated US Stem Cell Clinic, and two medical professionals who were involved in the procedures.

The suits were settled for undisclosed sums, with a confidentiality agreement that prevents Yaffa from naming the women or the company involved. Noble and Bade also told BuzzFeed News that they were not allowed to discuss their cases.

This litigation has been resolved to the mutual satisfaction of the parties, Yaffa said.

A couple of days after her injections, Bade turned up at the Bascom Palmer Eye Institute with bleeding retinas. Again, her eyesight rapidly deteriorated. A year later, she could just detect a hand waving in front of her face with her right eye, and had 20/200 vision in her left. That is the legal threshold for blindness, and means she could read an eye chart at 20 feet only as well as a person with normal vision standing 200 feet away.

Both womens eyesight would likely still be fairly good had they not been given the injections. Macular degeneration typically proceeds pretty slowly, Albini said.

Neither Mike Toms, US Stem Cells CEO, nor Kristin Comella, the companys chief science officer, returned emails and phone calls from BuzzFeed News. Comella is described on the companys website as a world renowned expert on regenerative medicine. She is not a medical doctor, and is enrolled as a PhD student in biomedical engineering at Florida International University in Miami.

Kristin Comella, US Stem Cells chief science officer, in a promotional video. youtube.com

ID: 10708284

The company responded instead with a statement from its PR firm, Becker Public Relations, which said: Since 2001, our clinics have successfully conducted more than 7,000 stem cell procedures with less than 0.01% adverse reactions reported. We are unable to comment further on specific cases due to patient confidentiality or legal confidentiality obligations. Neither US Stem Cell nor US Stem Cell Clinic currently treats eye patients.

On its website, US Stem Cell Clinic says it offers treatments for conditions from Parkinsons disease to congestive heart failure. US Stem Cells PR company would not say how many of the 7,000 procedures the company claims to have performed involved patients with eye diseases.

While the blinding of three patients is an extreme example, experts who follow the stem cell industry worry that other people may have been harmed by clinics offering unproven treatments, without their cases coming to public attention.

What Im most worried about is that this may be the tip of the iceberg, Paul Knoepfler, a stem cell biologist at the University of California, Davis, told Buzzfeed News. Last year, he and Turner of the University of Minnesota published a survey that identified 570 clinics offering unproven stem-cell treatments across the US.

Most of these clinics argue that their treatments do not need to be regulated by the Food and Drug Administration (FDA) because they are merely injecting peoples own stem cells back into their bodies. The FDA maintains that these cells count as drugs, which it must approve for clinical use, if they are more than minimally manipulated and are not replacing cells with the same basic function.

Last September, the FDA held a two-day hearing on treatments based on human cells. The FDA is evaluating the feedback we received at the hearing, along with the written comments, as we work to finalize our guidance, agency spokesperson Andrea Fischer told BuzzFeed News by email.

Its unclear whether that will to lead to a crackdown on clinics offering unproven stem-cell treatments especially as President Donald Trumps nominee for FDA commissioner, Scott Gottlieb, in 2012 co-wrote an Op-Ed for the Wall Street Journal criticizing the agencys efforts to regulate cells as drugs.

The FDA is perennially complaining to Congress that it lacks the resources to do its day job of regulating products that fall squarely in its purview, Gottlieb and his co-author wrote. Yet in chorus, the agency is always seeking novel authority to insert itself into new areas of science where its mandate is shaky.

Whatever the FDA does next, Turner argues that the NIH should do more to screen the listings posted on ClinicalTrials.gov.

The information on ClinicalTrials.gov is provided by the study sponsor or principal investigator and posting on ClinicalTrials.gov does not necessarily reflect endorsement by the NIH, Renate Myles, an NIH spokeswoman, told BuzzFeed News by email.

Earlier today, the NIH added a similarly-worded disclaimer to the website. Myles said that the change was made because of the concerns raised by Alibinis paper.

It is time NIH representatives stopped giving boilerplate responses, Turner said. They should have addressed this problem before patients were harmed.

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These Women Went Blind After A Florida Clinic Injected Fat Cells Into Their Eyeballs - BuzzFeed News

An international research team, led by scientists at University of California San Diego School of Medicine, has created the first cellular model of anorexia nervosa (AN), reprogramming induced pluripotent stem cells (iPSCs) derived from adolescent females with the eating disorder.

Writing in the March 14th issue of Translational Psychiatry, the scientists said the resulting AN neurons -- the disease in a dish -- revealed a novel gene that appears to contribute to AN pathophysiology, buttressing the idea that AN has a strong genetic factor. The proof-of-concept approach, they said, provides a new tool to investigate the elusive and largely unknown molecular and cellular mechanisms underlying the disease.

"Anorexia is a very complicated, multifactorial neurodevelopmental disorder," said Alysson Muotri, PhD, professor in the UC San Diego School of Medicine departments of Pediatrics and Cellular and Molecular Medicine, director of the UC San Diego Stem Cell Program and a member of the Sanford Consortium for Regenerative Medicine. "It has proved to be a very difficult disease to study, let alone treat. We don't actually have good experimental models for eating disorders. In fact, there are no treatments to reverse AN symptoms."

Primarily affecting young female adolescents between ages 15 and 19, AN is characterized by distorted body image and self-imposed food restriction to the point of emaciation or death. It has the highest mortality rate among psychiatric conditions. For females between 15 and 24 years old who suffer from AN, the mortality rate associated with the illness is 12 times higher than the death rate of all other causes of death.

Though often viewed as a non-biological disorder, new research suggests 50 to 75 percent of risk for AN may be heritable; with predisposition driven primarily by genetics and not, as sometimes presumed, by vanity, poor parenting or factors related to specific groups of individuals.

But little is actually known about the molecular, cellular or genetic elements or genesis of AN. In their study, Muotri and colleagues at UC San Diego and in Brazil, Australia and Thailand, took skin cells from four females with AN and four healthy controls, generated iPSCs (stem cells with the ability to become many types of cells) from these cells and induce these iPSCs to become neurons.

(Previously, Muotri and colleagues had created stem cell-derived neuronal models of autism and Williams syndrome, a rare genetic neurological condition.)

Then they performed unbiased comprehensive whole transcriptome and pathway analyses to determine not just which genes were being expressed or activated in AN neurons, but which genes or transcripts (bits of RNA used in cellular messaging) might be associated with causing or advancing the disease process.

No predicted differences in neurotransmitter levels were observed, the researchers said, but they did note disruption in the Tachykinin receptor 1 (TACR1) gene. Tachykinins are neuropeptides or proteins expressed throughout the nervous and immune systems, where they participate in many cellular and physiological processes and have been linked to multiple diseases, including chronic inflammation, cancer, infection and affective and addictive disorders.

The scientists posit that disruption of the tachykinin system may contribute to AN before other phenotypes or observed characteristics become obvious, but said further studies employing larger patient cohorts are necessary.

"But more to the point, this work helps make that possible," said Muotri. "It's a novel technological advance in the field of eating disorders, which impacts millions of people. These findings transform our ability to study how genetic variations alter brain molecular pathways and cellular networks to change risk of AN -- and perhaps our ability to create new therapies."

Story Source:

Materials provided by University of California - San Diego. Original written by Scott LaFee. Note: Content may be edited for style and length.

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Model of anorexia nervosa created using stem cells - Science Daily

Keith Sharon, The Orange County Register (TNS) 9:56 p.m. CT March 15, 2017

Jack Sage has been receiving an experimental treatment where a doctor injects stem cells into his brain to treat his Alzheimer's disease.(Photo: Paul Rodriguez, TNS)

IRVINE, Calif. More than eight years after he realized something was wrong, after, as he described it, My brain went

Whats the word? Foggy, Jack Sage finally said after several seconds of silently coaxing his synapses to fire.

More than eight years after his brain went foggy, four years after he was diagnosed with Alzheimers disease and two years since he began an innovative and extremely invasive therapy, Sage said he is being flooded by memories that seem new, or, at the very least, feel easier to retrieve. His daughter, Kate, thought Sage had suddenly begun to open up about his past because he knew his time was growing short.

He should not know who I am at this point, Kate said.

His doctor, Christopher Duma, hopes Jack Sage goes down in history as the one-man turning point in the treatment of Alzheimers disease, while others are skeptical about what Duma has done to Sages brain. Everyone agrees that Alzheimers disease is an exploding problem.

The California Alzheimers Disease Data Report from 2009 projected a 67 percent increase between 2015 and 2030 in residents in Los Angeles, Orange, Riverside and San Bernardino counties living with Alzheimers disease up to 498,137. The same report references a study, between 2000 and 2004, in which 58 percent of the deaths among people 65 and older in California were attributed to Alzheimers disease.

The Alzheimers Association reported that 610,000 Californians 65 or older had the disease in 2016, and it estimated increases to 690,000 by 2020 and 840,000 by 2025.

On a cool recent night, Sage, a handsome, fit, 82-year-old, sat next to his wife Gloria talking about his children (It is significant that Sage remembers their names James, 46, Kate, 50, and Kelly, 56), recalling when he and Gloria moved into the Newport Beach house with a view of the Pacific Ocean (1990), laughing about their first date at the Bel-Air Country Club (1979), recounting his years as a labor negotiator and executive for Del Monte, Allied Chemical and Continental Airlines (1970s and 60s) and going all the way back to the jack hammering he did in the nickel mines (mid-1950s) in Northern Ontario, Canada.

At this point in his illness, his doctor said he should be having more trouble remembering the perilous tunnels of the Sudbury nickel mine.

You drill into the granite, Sage said. You put dynamite in the rock. You dynamite it. Then you shovel out whats left.

And mining, you might say, is what is happening in Jack Sages brain.

Dr. Christopher stands in front of an MRI of Jack Sage's brain on Feb. 28, 2017 at his office in Irvine, Calif. Duma conducted phase one of clinical trials on a new treatment for Alzheimer's disease called intra-cerebro ventricular injection of autologous mesenchymal stem cells. He basically took fat cells from Jack Sage's body, spun them down to stem cells and then injected them back in to Sage's brain.(Photo: Jeff Gritchen, TNS)

Sages series of recollections, including his exploits on the golf course in Indian Wells where he has a second home and plays several days a week flashbacks representing the three main components of long-term memory: semantic (recalling the meaning of words), episodic (recalling autobiographic milestones) and procedural (recalling how to accomplish tasks) prompted a grin from Duma, the brain surgeon who, for $10,000 per treatment and without insurance coverage, cut a hole in the back of Sages head and injected a stem cell serum that had been sucked out of Sages love handles.

Is this the Alzheimers breakthrough the world has been waiting for? Or, is this unproven medical procedure what University of Minnesota bioethicist Leigh Turner calls quackery and flimflam? Is this an unsafe, money-grab it is being conducted outside the approval process of the Food and Drug Administration preying on the most vulnerable among us?

Turner has written extensively and critically about the Cell Surgical Network (CSN), for which Duma, whose home hospital is Hoag in Newport Beach, is listed as a network physician. The CSN promotes the stem cell revolution, which its literature claims, is an appropriate treatment for people suffering from a variety of inflammatory and degenerative conditions in other words, for cancer, diabetes, bad knees and hips as well as multiple uses in cosmetic surgery.

You dont just start dumping things into peoples brains, Turner said. The problem is people may spend a lot of money and find there is no benefit. He (Duma) is exposing people to serious harm. Fat cells dont belong in peoples brains.

Sage is the first patient in Phase I of a clinical study officially called Intracerebroventricular injection of autologous abdominal fat-derived, non-genetically altered stem cells. Sage was the first Alzheimers patient anywhere to have his own liposuctioned cells injected directly into his brain. He has received eight injections (about two months apart) since November 2014.

Duma quickly offers a qualifier. It is far too early to tell if what he has done to Sage will indeed change the world. He said Sage and, later, 19 other patients have not been harmed by the procedure, and that safety is the only criteria in Phase I. Whether the treatment is effective is a question for Phase II, for which Duma is hoping to attract private funding. Also, he wrote a letter to the national Alzheimers Association asking for $700,000 to continue his work. He was instructed to apply officially later this year. If he gets the grant, the fees for his patients would be waived.

Early in the process, Duma is excited by Sages results.

Sages most recent cognition scores have risen from 45 on the 100-point Memory Performance Index in March 2015 to 54 in September 2015. The volume of his hippocampus the memory center of the brain has grown from the fifth percentile before his first treatment to the 28th percentile after his fourth treatment to the 48th percentile after his eighth treatment.

My golf game is getting better, said Sage, who, heart permitting, plays several times per week. Sages brain isnt his only problem. He has a long history of heart ailments that have required the insertion of 12 stents to keep his arteries open.

You cant make a global conclusion based on one patient, but its a huge turning point, Duma said with the confidence of someone who probes brains for a living.

Duma is somewhat of a maverick in the medical world, a brain surgeon who regularly shuns a scalpel for the gamma knife, a futuristic laser for removing brain tumors. He is known outside the operating room for playing keyboards in bands that specialize in 1970s-era covers of groups such as Genesis, Yes and Emerson, Lake and Palmer. As a child, he was a classmate of John F. Kennedy Jr. at The Browning School in New York City. We called him John John, Duma said.

Duma realizes he will face opposition to his stem cell/brain injection therapy. But, as in all breakthroughs, someone has to be first.

I could have harmed people, he said. I took an enormous leap.

Alzheimers patients dont get better.

They get diagnosed, lose their dignity and die.

The speed at which death occurs is the only variable.

In the depressing world of Alzheimers treatment, Sage and Duma represent equal parts hope and skepticism. The Orange County Register contacted universities and research centers across the country, including Stanford, Harvard, Duke, Florida International, UC Davis, and some of the interview requests were denied while other calls were not returned. Very few medical experts want to talk about the combination of stem cells and Alzheimers disease, apparently because they know so little about it.

An Alzheimers patient improving because of therapy? Im hopeful its true. Im hopeful its true for all patients, said Joshua Grill, the co-director of the Memory Impairments Neurological Disorders (MIND) institute at UC Irvine. We are in dire need.

Jack Sage and his wife Gloria react in January to the positive results of Jack's latest MRI from Dr. Christopher Duma, left, at their home in Corona del Mar, Calif. More than eight years after his brain went foggy, four years after he was diagnosed with Alzheimer's disease and two years since he began an innovative and extremely invasive therapy, Sage said he is being flooded by memories that seem new, or, at the very least, feel easier to retrieve.(Photo: Paul Rodriguez, TNS)

But, Grill continued, One study does not a revolution make. Ive never read anything about this (Dumas work), and I dont know what science is behind it.

Dean Hartley, Director of Science Initiatives at the Alzheimers Association, knew about Dumas work.

This is new territory, Hartley said. But with one patient, No, you cannot say this is a game-changer.

Hartley said many studies fail at the Phase II level, where more and more people are exposed to the therapy.

Still, Hartley said Dumas work is encouraging.

We want to see things like this happen, Hartley said.

Its not as if Duma is conducting his research in secret. He spoke about his study in public forums twice last year Sept. 28 at the Congress of Neurological Surgeons in San Diego, and Oct. 1 at the International Society for Cellular Therapy in Memphis.

Duma said he is nearly finished writing a paper about his work that he hopes will be published in a peer-reviewed journal.

In 1993, Christopher Duma was working at Good Samaritan Hospital in Los Angeles when he and his colleagues began injecting stem cells into the brains of patients with Parkinsons disease. They were making some progress, he said, but politics intervened. Some of the stem cells they were using came from aborted fetuses. Pressure from anti-abortion groups shut that program down.

Fifteen years later, Duma was assisting plastic surgeon Michael Elam on a face-lift on a Parkinsons patient when Elam said, We need to talk about stem cells.

Elam introduced Duma to Drs. Mark Berman and Elliot Lander, the founders of the Cell Surgical Network.

Berman and Lander had been separating stem cells from fat by using a centrifuge (which they own the patent for) and injecting them into knees and hips and other places where injuries had occurred. Their work had passed an Institutional Review Board after 1,524 patients were treated with no adverse effects, Berman said.

If you want to repair an injury, Berman said, the best tissue is the stem cell.

In 2013, Duma suggested a new target for stem cell therapy: the brain.

Duma, with Berman, Lander and Elam as co-authors, tried to begin a study of brain/stem cell injections. But their first attempt at Institutional Review Board approval was denied because they hadnt done animal testing. So they got Dr. Oleg Kopyov at Cal State Northridge to conduct tests on rats.

With the help of Kopyovs work, Duma got Institutional Review Board approval. They chose not to take the usual next step FDA approval.

The Institutional Review Board was expecting us to go through the FDA, Lander said. But there are hundreds of obstructions. The FDA approval process usually takes between eight and 12 years, according to the online journal Medscape.com.

Duma said stem cells present a quandary for the FDA because stem cells are not a drug, and theyre not food. Clinics that take stem cells out of the body and put them back in without additives argue that they are exempt from FDA mandates.

We have been harvesting fat from abdomens and putting them in the brain during brain surgeries since the 1920s, Duma said. We do it nearly on every case for pituitary tumors, acoustic and skull base tumors and for conditions of spinal fluid leakage since the 1920s. If the FDA ruled that harvested autologous fat cannot be used in the brain, then it would change nearly a century of neurosurgical standard of care.

Someday, Duma said he hopes the FDA will recognize his work.

The work cant wait, he said.

Jack Sage and his wife Gloria at their home in Corona del Mar in January.(Photo: Paul Rodriguez, TNS)

In August 2013, Jack Sage staggered into the office of Dr. William Shankle in Newport Beach.

Shankle, a renowned expert in cognitive disease he is the author of the Memory Performance Index that is used around the world diagnosed Sage with two problems: Alzheimers disease and hydrocephalus (fluid on the brain). Sage needed a shunt in his brain to drain the fluid and relieve the pressure.

So Shankle walked him down the hall (their offices are yards apart on the same floor in the same building) and introduced Sage to Christopher Duma, medical director of Hoag Hospitals Brain Tumor Program, and the surgeon who would put in the shunt.

Duma remembers that first meeting. Sage was in straight-line cognitive decline, Duma said.

Shankle would not grant an interview about Duma or his treatment. Shankle said he is wary of hocus pocus about Alzheimers disease without saying that Duma has done anything wrong. More than a decade ago, Shankle tried a surgical stem cell therapy on patients. He removed patients stem-cell-rich omentum, a fatty sheath covering the abdomen, cut open their skulls and stretched the omentum directly on their brain. Four of the six patients he studied had serious complications from the surgery.

The patients improved in cognitive tests, but the surgery was too much for them.

The method of delivering the treatment was radical (surgical transposition of the greater omentum to the surface of the brain while keeping the blood supply intact), Shankle wrote in an email. After showing that it really works, my goal was to never do the surgery again but find a different way of delivering these critical factors less invasively.

Sage was the patient Duma had been waiting for.

Jack was a man who was doomed, Duma said. He looked like classic Alzheimers. He had no ability to follow a train of thought. He was asking and re-asking the same questions. People like Jack are there, but theyre not there.

Sage was perfect for Duma for other reasons. He has always been a fitness nut cycling, tennis, golf, skiing and 10K runs were all part of his lifestyle. Kate Sage said he has been ordering salmon and spinach for dinner at restaurants for years.

Jack is the experimental model, Duma said. He is the brave one.

During two years of treatments, Sage has either maintained or slightly improved his cognitive health. He had a major heart attack in 2016, making his brain less of a cause for concern than his heart.

Kate said she doesnt know if Dumas treatment is working.

Its hard for me to say this is miraculous, Kate said.

She said she doesnt worry about his brain as much anymore.

Hes going to drop dead with some kind of a heart thing, she said. Hes not going to lose his memory.

Jack Sage passed his written test recently to renew his driver's license.(Photo: Paul Rodriguez, TNS)

The tragedy of Alzheimers disease is that it not only steals the history that makes us who we are. It takes our skills, our beliefs, our independence, our ability to love.

So far, Jack Sage is still Jack Sage. Obviously, he doesnt know if he would be the same without Dumas treatments.

I can tell Im getting better and better, Sage said. Is that pure optimism? The Placebo Effect?

In January, Jack Sages drivers license came up for renewal. He said hes able to remember driving directions without problem. He still navigates the route from his home in Newport Beach to his other home in Indian Wells. But, he was required to pass the written test, and Sage feared he wouldnt be able to remember the complex rules of the road.

I was worried, he said.

But he passed, and his license was extended five years.

His improved memory, he said, sometimes catches him by surprise.

These memories come up when I dont even think about it, Sage said.

Sometimes, the memories take Sage places he doesnt want to go.

When he worked in the nickel mines in the 1950s, he and his first wife had a son.

His name was Mark, Sage said, speaking slowly as if the memory was bubbling up from depths he didnt want to consider. We rented a house with a playroom. My wife went shopping, and I was upstairs

I was working on my school work for McMaster University

Mark fell

we had a drainage basin inside the house

when I got to him, he was gone

Sage stopped talking as if flooded by new emotions over the death of his son.

We were distraught, he said. It was tough times for years.

In the murky world of Alzheimers therapy, Jack Sage is still mining.

Read or Share this story: http://www.gosanangelo.com/story/life/wellness/2017/03/15/alzheimers-treatment-injecting-stem-cells-into-brain-breakthrough-quackery/99240794/

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Is Alzheimer's treatment of injecting stem cells into the brain a breakthrough or quackery? - San Angelo Standard Times

See America, Allergans initiative to fight against preventable blindness in the United States, today unveiled a powerful video featuring award-winning actor and hip-hop artist Common, that urges Americans to stand in the way of darkness.

The video harnesses Commons striking spoken word ability, calling on Americans to fight against vision loss and prioritize their vision. Common highlights the 61 million Americans at-risk of severe vision loss, and challenges us all to imagine a life without sight.

Im proud to join Allergan in the fight against preventable blindness, said Common. Sight is something that far too many of us take for granted. I hope our message resonates with people across the country, no matter what age or background.

Commons involvement echoes the mission of Allergans See America initiative by raising awareness to make sure that each and every one of us makes the time to prioritize our vision. Taking steps as simple as regular comprehensive eye exams can help detect eye diseases like glaucoma, diabetic retinopathy or age-related macular degeneration early, before irreversible damage is done.

On Commons partnership with See America, We are excited to have joined forces with Common to raise awareness of the important issue of preventable blindness in America. This video marks the first of many ways in which we aim to educate and engage the public. Common shares our bold approach to life, and we believe that this video will take us one step closer to nationwide appreciation for the gift of sight, said Herm Cukier, Allergan Senior Vice President of Eye Care.

To watch the video, and to learn more about See America, visit http://www.SeeAmerica.vision.

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Common Joins See America In The Fight Against Preventable Blindness - Look To The Stars

Diana Applewhite believes her faith in God will see her sight restored someday. (Picture by Ricardo Leacock)

During March, the Month Of The Disabled, the Wednesday Woman column will focus on people with disabilities.

DIANA APPLEWHITE went blind overnight.

SHE WENT TO SLEEP being able to see, but the next morning her sight was completely gone, changing her life completely.

It happened July 1, 2009, she said. I will never forget that date. I went to bed early because I was having a bad headache and the Sunday morning I woke up my usual time to prepare for church, but I thought outside was very dark. I turned on the light and it was still dark so I thought the electricity was off.

Even after she went for her cell and could not seethe mobile phone light, she was puzzled but did not think of the worst.

I was not thinking about loss of eyesight, nothing like that, she said. I do not know how to describe the feeling I felt in words; it was like someone knocked all the breath out of my lungs. I just fell to the floor rolling bout hollering and crying.

Yet, Applewhite, who is diabetic, said she always knew of the risk of blindness as a result of diabetic retinopathy, which is caused by high blood sugar levels damaging the back of the eye (retina).

Because she had the condition, she always went for her opticians appointment which showed that everything was normal on each occasion.

Eight years on, Applewhite has found it hard to accept the loss of her sight and believes that God can restore it if He so chooses.

Full acceptance, no; I believe my eyesight will be restored in Jesus name, she said.

Going back to that Sunday when I was rushed to the hospital and they did the tests, they were saying you will never see again. That is one conversation I will never forget as long I live; (the doctor) just ran off this long list of things I would never be able to do again; like if he was the hammer and I was the nail and he was driving the message home. I felt so bad then, that all I could do was cry, but now I know I serve a living God and in all things I give thanks.

Applewhite said the part that kerfuffled herwas that there were no symptoms or anything to indicate an eyesight problem. She ate what she considered a healthy diet and always went for medical check-ups.

Adjusting was the hardest part, she said.The first two years I cried every single day andgetting to wrap my mind around the idea of doing things differently. I have a daughter and a son.My daughter was eight years at the time and shewas a real trooper; she stepped up and helped me make the adjustment.

Applewhite and her daughter, as young asshe was, created a series of hand signals to aidmobility. For instance, they would walk holdinghands and if her daughter kept her hand flat, itwas flat road, when her hand dipped it meant tostep down and if it went up it meant to step upand so on. So when they were out in public, Applewhite did not have to use a cane.

Mother and daughter would also put little bumps on the washing machine, microwave and push-button telephone so that Applewhite would still be able to use household appliances. Everything in the house has remained in the same position to allow her to get around with no issues.

She had access to disability trainingwith the National Disabilities Unit a few months after her vision loss, but by then, shewas already gettingby, thanks to herdaughter.

Cannot and never are some of the words that Applewhite chooses to keep out of her vocabulary. Because of her disability, people tend to say she cannot do certain things, but she is determined always to show them how wrong they are.

She still goes totown, to the hospitaland doctor on her ownand is living life as normally as she can.

She said her dayshave not changed much; the only thing she cannot do is read, but she still cooks, washes, cleans, takes the bus and doesher own shopping.

Applewhite hasbecome very active in the Barbados National Organisation of the Disabled (BARNOD)and now serves as chairperson of education and public relations officer. They say I talk a lot, Applewhite said witha laugh.

She serves onseveral other committees that keep her busy and active. In fact she isbusier than when shehad a job.

Applewhite said she likes to push awareness of disabilities and when any new information is announced, she puts it in the public domain.

When we keep the public informed then people do not have to be saying, oh I dont know how to deal with them. They realise that we are all the same we just do things differently, she said.

One of the major changes she has seensince she lost her sight is that she has not worked since. Having worked at a major bank in sales, Applewhite said shewould like to set up her own business.

I am not ruling out having an employer completely, but I do not think I can take the humps and grumps of working for someone., she said. I am at the age where I want a more relaxed environment.

To anyone at the beginning stage of the journey towards vision loss, Applewhites advice is not to give up on life even though blindness might seem like a death sentence at first.

They can still live a full life, she said. You can do all the things you want to do; there are organisations that can help you adjust. Also, God is able and through faith, your sight can be restored.

lisaking@nationnews.com

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WEDNESDAY WOMAN: Faith despite blindness - Nation News

Ceramist Susan Beiners work has been exhibited in China, France, the Netherlands and across the nation, but it took some persuading to get her to exhibit her creations at Temple Solels latest Art Showcase.

After some cajoling, Beiner relented and now her earlier work is on display at Temple Solel through May 31. A reception and talk featuring Beiner are scheduled for 10:30 a.m. Sunday, April 2, at Temple Solel, 6805 E. McDonald Drive, Paradise Valley.

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Janet Perez is a freelance writer based in Phoenix.

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Ceramics artist inspired by nature, biotechnology - Jewish News of Greater Phoenix