Archive for the ‘Stem Cell Clinics’ Category

FDA: Florida Stem Cell Clinic Violates Law | Health News Florida

Stem Cell Clinics | Posted by admin
Sep 15 2018

A South Florida clinic that promotes controversial stem-cell treatments for a wide range of ailments is among the centers receiving a written warning that it is violating federal public health laws.

The U.S Food and Drug Administrations letter was addressed to Dr. Thomas A. Gionis, owner and chief surgeon of the Miami Stem Cell Treatment Center located in Boca Raton. Gionis also owns a stem cell treatment center in Irvine, Calif.

The letter shows that a third Gionis clinic in New York City apparently closed after FDA inspections of all three clinics was carried out from July through September 2015.

Dr. Gionis facilities are among more than 170 clinics across the country that are selling experimental stem cell procedures for dozens of diseases and conditions a mushrooming industry that has flourished despite little evidence of its safety or effectiveness.

Descriptions on the website say that Dr. Gionis and other practitioners inject or infuse a liquid that is said to contain stem cells derived from the patients own fat tissue, removed through liposuction. The clinic lists a large number of illnesses for which it says the treatments are appropriate, including: heart and lung disease, stroke, multiple sclerosis, spinal disc disease and auto-immune problems like lupus.

And his clinics are not the only ones operating in Florida. Internet search indicates this type of stem-cell treatment is available at clinics in Jacksonville, Orlando, St. Petersburg, Sunrise and a number of other sites throughout the state.

The rise of the U.S. stem cell industry illustrates how quickly fringe medicine can outpace government oversight. Over the last five years, academic stem cell researchers say they have watched in dismay as doctors treat patients with experimental techniques that they say could take years, if not decades, to become sound medicine.

"It's sort of this 21st century cutting-edge technology. But the way it's being implemented at these clinics and how it's regulated is more like the 19th century. It's a Wild West," says Dr. Paul Knoepfler, a stem cell researcher at the University of California at Davis.

The FDA letter to Dr. Gionis, dated Dec. 30, provides some insight into how the FDA is addressing the issue. In difficult-to-parse language, it says that the substance that Gionis is processing and injecting amounts to a drug that has not been approved for safety and usefulness.

The writer, Mary Malarkey, director of an office in the FDAs Center for Biologics and Research, says that if Gionis maintains his treatments are part of a clinical trial, as his website suggests, he would need to submit an Investigational New Drug (IND) application to FDA.

The FDA official says an earlier defense by the clinic that the chemical used in the mixture has been changed doesnt make it acceptable without more information.

Health News Florida was not able to reach Dr. Gionis on Monday, but left a message with his staff.

The Associated Press reported last May that entrepreneurial ventures using fat-derived stem cells have proliferated throughout the country. Scientists engaged in authorized stem-cell research said states have not stepped up to regulate the ventures and called on FDA to do so.

The FDA has scheduled a public hearing for April on draft guidelines for fat-derived stem-cell treatments that the agency released a few months ago. That led some to mistakenly think the treatments are being subjected to new regulations, said FDA spokeswoman Sarah Peddicord. She said the regulations went into effect in 2005.

The law has not changed, she said. What the agency released are guidelines that FDA hopes will help the industry and the public understand the law.

People need to understand how to implement the regulations, she said. The guidelines are just to explain the regulations.

Stem cells have long been recognized for their ability to reproduce and regenerate tissue. And while there are high hopes that they will someday be used to treat a range of debilitating diseases, critics say stem cell entrepreneurs have little more than anecdotes to support their offerings.

In 2010, there were only a handful of doctors promoting stem cell procedures in the U.S., mainly plastic surgeons promoting "stem cell facelifts" and other cosmetic procedures. But today there are clinics throughout the country promoting stem cells for dozens of conditions and diseases, including Alzheimer's, arthritis, erectile dysfunction and hair loss. The cost of these procedures is high, ranging from $5,000 to $20,000.

Many of the businesses are linked in large, for-profit chains which offer doctors the chance to join the franchise after taking a seminar and buying some equipment.

The largest of these chains is the Cell Surgical Network, co-founded in 2012 by Dr. Mark Berman, who spent 30 years as a Beverly Hills plastic surgeon before working with stem cells. His company offers stem cell procedures for more than 30 diseases and conditions, including Lou Gehrig's disease, multiple sclerosis and arthritis.

He and his partner adapted technology from Asia into a liposuction-based procedure in which fat is pumped out of patients' abdomen, processed with drugs and equipment and then injected back into the body.

Berman says this fat-based "soup," is rich in shape-shifting stem cells that have the potential to treat everything from neurological diseases to achy joints.

"I don't even know what's in the soup," says Berman. "Most of the time, if stem cells are in the soup, then the patient's got a good chance of getting better."

The clinics insist that their treatments are safe, but routinely require that patients sign waivers.

Patients of Dr. Zannos Grekos, a Florida cardiologist specializing in stem cell therapy, were also required to sign a consent form, acknowledging the procedures' risks, including death.

But families of two Grekos patients who died under his care say he downplayed the risks. Gina Adams, daughter of patient Richard Poling, says her family was told her father would be "back on the golf course the next day" after a procedure intended to treat a lung condition that made breathing difficult. The cost was $8,000.

In March 2012, Grekos harvested fat from Poling's abdomen and sent it to an off-site processing facility to isolate the stem cells. Later that afternoon, he directed an assistant to infuse the resulting mixture into the patient's bloodstream.

Poling suffered cardiac arrest and was pronounced dead after being rushed to a local hospital.

Two years earlier, in 2010, 69-year old Domenica Fitzgerald suffered a stroke after Grekos infused unfiltered bone marrow-derived stem cells into the arteries of her brain. The state report concluded "it was virtually inevitable that the procedure would clog blood vessels in the brain and cause a major and very possibly fatal stroke." Fitzgerald suffered severe brain damage and was removed from life support several days later.

Jack Fitzgerald says his wife, who used a wheel chair, had hoped that stem cells might help her walk again.

Not until 2013, after Poling's death, did the Florida Board of Medicine vote to revoke Grekos' license.

Though barred from practicing medicine in Florida, Grekos continues to treat patients in the Dominican Republican through his company Regenocyte, which promotes treatments for autism, dementia and many other diseases.

He believes the two deaths were unrelated to his care the state targeted him to discourage other doctors from working with stem cells, he says.

State actions against stem cell doctors are rare. That's led industry critics to conclude that regulation must come from the FDA, which regulates medical products on a national level.

But the FDA's authority to regulate stem cell procedures is not clearly defined and has been debated by legal experts for years.

Now, the FDA appears to be stepping up its oversight. In the last days of 2014, it released draft guidelines dealing with the popular fat-based stem cell technique. The agency said that processing fat to extract stem cells for medical use essentially creates a new drug, which cannot be sold in the U.S. without the agency's approval.

But many stem cell doctors continue to argue that they don't need FDA permission because they are not creating drugs, but performing in-office surgical procedures.

For now, Berman says he has no plans to change his business.

"How is it unethical if you're actually helping people, even if we don't have evidence-based studies to prove it?" he asks.

Carol Gentry is a special correspondent for WUSF in Tampa. Health News Florida receives support from the Corporation for Public Broadcasting.

View post:
FDA: Florida Stem Cell Clinic Violates Law | Health News Florida

Patients guide to treatments – The Niche

Stem Cell Clinics | Posted by admin
Jul 14 2018

Updated for 2016. Top 10 list of important, easy to understand facts for patients about stem cell clinic treatments.

For better or worse, I am in the unique position of being a stem cell scientist and also a former cancer patient. Looking on the bright side this gives me a unique perspective on things compared to many of my colleagues.

I know there are thousands of people out there looking for more practical information about stem cell therapies and treatments. These folks understandably are using the Internet to look for some clear, good info on stem cell treatments either for themselves or their loved ones. Too often the info that is out there is either wrong, partially misleading, biased, or overly complex.

So in this post I want to address this need for trustworthy factual information and no-nonsense perspectives. I am speaking as a scientist, patient advocate and cancer survivor in the form of 10 key realties list belowto help you guide your way through the jungle of stuff out there about stem cells. As mentioned above, I have now updated this post for 2016 as some things have changed in big waysin just the past few years.Keep in mind this is not medical advice and you should absolutely talk to your personal doctor with whom you should make your own decisions.

1) Stem cells are often essentially a type of drug and possibly permanent in your body after a transplant.Yeah, stem cells can be extremely unusual drugs, but they are often drugs even if some argue they arent. The FDA considers them drugs in many cases. Unlike other drugs, once a patient receives a stem cell drug, it will not necessarily simply go away like other drugs because a stem cell drug consists of living cells that often behave in unpredictable ways. What this means is if the stem cells are doing bad things your doctor has no way to stop it. You have no way to stop it. Also because stem cells are alive they can grow inside your body, move around, and change. This can be helpful or harmful, but the big point is that it is not something that is controllable or reversible.

2) Side effects.Like any medical product, even aspirin,stem cells treatments will have side effects. Not maybe. Definitely. Our hope is the side effects will be relatively mild. Different kinds of stem cells have variable risk profiles, but if someone tells you that the stem cell treatment they are selling has no risks then that is a big red flag and I would walk away. They are either woefully lacking in knowledge or arent being honest with you. Sometimes clinics will either on their websites or in person acknowledge risks almost as sort of a disclaimer, but then theyll tell more casually that there arent really any risks. A common statement is The only risk is that it wont work. Thats false.

3)The only stem cell treatment explicitly approved by the FDA for use in the U.S. consists of versions of bone marrow/hematopoietic stem cell transplantation.What this means is that any other stem cell treatment you see advertised on Facebook or Google or elsewhere that indicates it will be given to you inside the U.S. is not FDA approved. The exceptions to this are if it is part of an FDA-approved clinical trial or it is using stem cells in a procedure that meets other criteria (e.g. being both homologous use and minimally manipulatedyeah I know these are jargon terms).

4)If you venture outside the U.S. for a stem cell treatment, use extra caution, but in 2016 also be very careful inside the U.S.Whether you travel abroad or closer to home, have a knowledgeable physician inside the U.S. guiding you, preferably your primary care doctor who mot often are not going to buy into hype. We have to avoid the trap of thinking that only the U.S. can offer advanced medical treatments and these days many American patients get their stem cell transplants here in the U.S. from dubious clinics.

5)Stem cells are not a cure-all.I am as excited as anybody about the potential of stem cells to treat a whole bunch of diseases and injuries, but they are not some kind of miracle cure for everything. When a doctor offers to inject some kind of stem cells into a patient either into the bloodstream or into a specific place that is injured such as a shoulder, we just do not know at this point if it will do any good with the exception of bone marrow transplant. You should start getting worried if the clinic tells you that one kind of stem cell such as fat, bone marrow, or amniotic stem cells can treat many different conditions. Theres no science behind that kind of claim. Stem cells are not a panacea.

Patients often mention to me that the doctors offering stem cell treatments told them that the treatments are proven safe.or that your own stem cells cannot harm youor that adult stem cells are harmless. I often tell people to think about how much research and how many questions they ask when looking to get a new car. You should bring at least that level of intensity (ideally much more) to getting info about stem cell transplants too as the stakes are even higher.Be skeptical. Ask many questions and if you arent convinced, then dont do it.

6)Dont let celebrities be your guide to medical care.The number of famous people getting stem cell treatments is increasing including sports stars and politicians. Dont let what these folks do influence what you decide to do about your health. Just because they are famous do not believe for one minute that they are any more informed than you or your personal doctor about medical treatments or stem cells. If anything I think sometimes famous people are more reckless with their health than average people like you and me.

7)Reach out to scientists as a source of info.As a scientist I am always happy to hear from people outside the scientific community with questions about stem cells and other research. I cant speak for all stem cell scientists but you might be surprised at how likely it is that if you send them a very short, clear email with one or two questions that they will respond and be helpful. We cant or shouldnt offer medical advice, but we can give our perspectives on stem cell research and its clinical potential, etc. Just do not cold call scientists as you are unlikely to find them that way and even if you do, they may be cranky. Email. If they dont reply try someone else and dont be offended they we didnt answer. Often times we may not answer because we are super busy. For instance, I often get more than 100 emails a day.

8)The people selling you non-FDA approved stem cell treatments want your money.As such they will do their best to convince you that their treatment is safe and effective. The more convincing they are then the more money they make. They may offer patient testimonials either from patients who truly believe they were helped or from people who are paid to say the treatment helped them. The bottom line is that the sellers of dubious stem cell treatments are generally in it for the big bucks. Admittedly I do think that some of these providers truly believe stem cells are helpful, but youll never see even them offering to give patients the cells at cost. These are instead very much for-profit operations.

9)NEWJust because something is called a stem cell clinical trial doesnt mean it really is and being listed on means a lot less than it used to.I am contacted weekly or even daily at times by patients or their families and they are rightly focused on getting information that they can trust. Many stem cell clinics call the treatments that they offer by the name clinical trial and thats often misleading. In the standard meaning of clinical trial the experimental therapy being tested has the FDAs approval to be used in the study, there are data supporting the study, and those doing the trial do not charge patients to be in it. You shouldnt have to pay to be a guinea pig. I think thats almost always going to be unethical on the part of those giving it. I often suggest that people turn to the federal website for information and that is still a great resource, but be aware that many pseudo-clinical trials are popping up on there that are really mostly about making money. They do not have FDA approval in many cases and there are other issues of concern. So even on that website use caution.

10)The most important thing is information/data and you have a right to see it before treatment.Before you or a loved one get a stem cell treatment, ask two key questions. First, is the treatment FDA approved and if not, why not? Second, can you please show me the data that proves your treatment is safe and effective? See what kind of answer you get. If they criticize the FDA or invoke a plot by big pharma to block stem cells then that is a warning flag. If they refuse to show you data, then that is a big red warning flag. They may say it is confidential or that it is not published yet, but as a patient you have a right to see the data, assuming they have any data at all.

These facts will likely change over the coming years, but right now I think they represent reality. I know as patients we need hope, but these unapproved stem cell treatments will at best take your money for nothing, and at worst will endanger you or your loved ones.

The post above is for information only and is not medical advice. All medical decisions should be made by patients in consultation with their personal physicians.

View original post here:
Patients guide to treatments - The Niche

Adult Stem Cell Therapy in Utah Docere Clinics

Stem Cell Clinics | Posted by admin
Oct 18 2017

Stem cells, specifically mesenchymal stem cells (MSCs), have been called patient-specific drug stores for injured tissues because of their broad range of healing abilities. MSCs are directly responsible for healing damaged tissues after injury. Upon encountering damaged tissue, they release proteins that decrease inflammation, kill invading microbes, and trigger the growth of new connective tissues and blood vessels.In the case of severe damage and cell death, MSCs have the ability to turn into healthy versions of damaged or destroyed cells that they encounter.

When we take MSCs from your own bone marrow, from your own fat, or from both, concentrate and/or isolate them, and then inject them directly into your problem area, we trick your body into thinking that there has been a new injury without actually causing any tissue insult, and you get a second chance at healing. In the case of advanced osteoarthritis where the population of stem cells has been depleted, we are repopulating the area with stem cells, and thereby restoring the bodys natural ability to heal itself.

Docere Clinics is an affiliate member of the Cell Surgical Network(CSN).It is the belief of the CSN that the most ethical approach to stem cell therapy is under the umbrella of IRB approved research protocols. An IRB is an Institutional Review Board;a committee responsible for approving and overseeing research on humans. IRBs are approved under the auspices of the U.S. Department of Human Research Protection. As such, our patients understand the investigational nature of our activities, are provided appropriate informed consents, and are followed continuously on an online database to chart their progress or any issues of concern. The efforts of the CSN will provide safety data,demonstrate effectiveness of treatments, and help to improve treatment programs going forward.

Here is the original post:
Adult Stem Cell Therapy in Utah Docere Clinics

At ClinicalTrials.Gov, Untested Stem Cell Clinics …

Stem Cell Clinics | Posted by admin
Oct 13 2017

Stem cell cultures growing in multi well sample tray.

Andrew Brookes/Getty Images

Macular degeneration is the most common cause of vision loss among the elderly. But for some people with the disease, a shot of stem cells to the peeper was all they needed to see again . For others, treatment left them permanently blind . What gives? Stem cell treatments like the one described abovehappening every day in 600 clinics across the USare not approved by the FDA, and in fact have never been tested in a clinical trial.

Eyes arent the only organ getting stabbed full of stem cells. Around the country, more doctors are marketing the therapy to treat everything from diabetes to asthma to erectile dysfunction. The procedure usually involves sucking out some of a patient's fat tissue with a liposuction needle, isolating their stem cells, and reinjecting them back into the place in their body that needs most healing. But because these are living tissues unique to every individual, results may vary. Advocates of the therapy say thats just the cost of doing cutting-edge medicine. Except, any proof they have that it is effective comes from data collected on patients who pay thousands of dollars for the treatment. Usually people pay money for medicine after theres proof it works. In the last few years, some of these stem cell clinicians have begun posting large-scale studies on a government-run website called, even though they're often not up to medical research standards or even in compliance with federal regulations. This allows them to masquerade their pay-to-participate studies as legit science.

According to a paper published today by the University of Minnesota, US companies have successfully registered 18 patient-sponsored stem cell studies on that publicly funded website. Only 7 of them disclose that patients pay their own way. None of them list the costs, which can range from $5,000 to $15,000 a treatment, outright. And none of them are actual clinical trials in the randomized, blinded, gold-standard sense of the phrase. Instead, theyre observational studies, based mostly on quality of life questionnaires that ask if youve had any adverse reactions to the procedure.

Leigh Turner, the bioethicist who penned todays perspective and who has become somewhat of a watchdog in the ballooning stem cell clinic industry, says this amounts to hijacking a public good and repurposing it into a free marketing tool. They dont have to pay for ads on television, people just come to them because its this trusted national resource, he says. Its all meant to suggest a seal of approval from the federal government. And thats whats so dangerously misleading, because it doesnt mean that all. It just means someone filled out a form and pressed a button.

Following the passing of the Food and Drug Administration Modernization Act of 1997, the National Library of Medicine established to serve as a source of information about publicly and privately supported clinical trials for patients, their families and caregivers, doctors and nurses, and the public. But the NIH doesnt independently verify the scientific validity of any trials posted to the site beyond a limited quality control review. That doesnt really include things like sound study design, compliance with current regulations, or ethical guidelines. In fact, the process is largely automated, and relies almost entirely on the honor system.

Megan Molteni

With 21st Century Cures Act, the Future of Regenerative Medicine Is "Inject and See"

Megan Molteni

The Feds Are Spending Millions to Help You Survive Nuclear War

Anna Vlasits

Scientists Brew Up the Creepiest Batches of Brain Balls Yet

NIH said in a statement that it is continuing to evaluate ways to improve its outreach to make sure that trial participants understand potential risks and benefits. That included adding a prominent disclaimer on the homepage in March 2017, stating: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study.

But that hasnt stopped stem cell therapy slingers from touting their clinical bonafides. Cell Surgical Network, an umbrella organization for more than 50 clinics that market the treatment directly to consumers, first registered on in October of 2013. At the time, the organization put out a press release noting that the NIH had registered its approved safety study, and that it was now cleared to enroll 3,000 people to study the adverse effects of stem cell treatments on arthritis, cardiomyopathy, Parkinsons, ALS, and a host of other inflammatory and neurological diseases. The listing of this study does not mention that research subjects are charged an average of $6000 to participate.

Elliot Lander, a urologist and co-founder of Cell Surgical Network says those costs are necessary because stem cell therapies dont make money like pharmaceuticals dothey can't be packaged up and mass-produced. Which means pharma companies and research institutions arent interested in footing the bill for clinical trials. And he says that while it might be worth noting the costs upfront, the NIH doesnt have a mandatory policy about including fees. Stem cell treatments have no business model, he says. So its left to physicians like myself to do the right thing by my patients, and get them regenerative medicine now, not 10-15 years from now. People dont need to be protected by Leigh Turner, they can do their own due diligence.

So far, at least 6,000 people have followed their due diligence to a treatment at one of Cell Surgical Networks clinics. The network keeps a database of all its patients and their outcomes, hoping for the day when the FDA decides to go from merely ignoring the proliferation of un-approved treatments to giving them a green light based on post-market data (a regulatory middle path floated by advocates like Lander.) In the meantime though, Cell Surgical Network is working with the FDA on an application for a real clinical trial, limited to just knee pain treatmentsthat will even include a randomized placebo. Its going to take us years and a few million dollars, says Lander. The walls are really high for this kind of thing. As they should be.

The rest is here:
At ClinicalTrials.Gov, Untested Stem Cell Clinics ...

Stem Cell Therapy and Its Revolutionary Purposes Guardian … – Guardian Liberty Voice

Stem Cell Clinics | Posted by admin
Sep 04 2017

Stem cell therapy is reaching another stage in the healthcare world by offering hope through revolutionary solutions to complex diseases. However, with progress come controversy.

Part of the debate lies in the disbelief stem cell therapy is as revolutionary asresearchers claim. The forerunners of this therapy want to replace the current treatment of Alzheimers, and cancer. There are even biotech scientists who claim experiments have shown promisebringing thebrain dead back to life, although, nothing concrete has been published.

Supporting scientists of the therapy have solid evidence thatevery disease originatesin specific cells. It is key to work with cells to find a potential cure for any illness. The first cell of a human is the stem cell; a pluripotent cell is a component of life and capable of replicating any other cell in the body. In fact, every cell in the human body comes from this cell. Pluripotent cellsare found in embryos or created from other cells making the process expensive.

With a cell capable of transforming into others, lab developers hope to find simple solutions to complexproblems. Alzheimers disease is the deteriorationof the brain cells (neurons), causingthem to die. Scientists can reverse thisby administrating stem cells into the brain to create new neurons, according to stem cell therapy supporters.

The Food and Drug Administration (FDA) is becoming the fiercest enemy of stem cell therapy. Recently, theagency sanctioned clinics that useunapproved therapies. They seizedvials of the smallpox vaccinefrom some clinics. The FDA attacked them for not having enough proof of their practices. Somehow, the FDA is right to think this way because of the public silence of the therapys developers. People need more information about the treatment and general development.

The medical gesture of health and procedures, as well asdiagnosis, is based on scientific and proven knowledge. Contrary to the aforementioned therapy, there is a long list of publishing in medicine. It is certain that there are professionals working on stem cells, but the mistrust is justified.

Whether the therapy is legit, trustworthy, or efficient, ithas a bright future. The need forlargeamounts of money to fund theproject is undeniable. Big relevant companies, such as CSL Behringare investing moneyto accelerate the growth of the therapy.

A new groundbreaking technique is being tested that couldbring brain dead patients back to life. People who cannot live without a machine. Specialists say it is impossible to reverse that kind of damage, but stem cells therapy offersa new alternative.

People notice how much power the stem cell industry has right now. Even if individualsdo not have the legal backing, they enjoy the advocacy of powerful individuals. It is sane to remember that the major scientific progress made in history was due to experimentation. Is better if it sounds impossible to accomplishbecause it can prove the human greatness to fight against something as natural as death.

Opinion News by Gian Torres Edited Jeanette Smith


CBS NEWS:FDA cracks down on clinics selling unapproved stem cell therapies BioPharma:CSL adding scalable stem cell gene therapy tech in $91m Calimmune buy Wall Street Pit:Brain Dead Patients Could Be Brought Back to Life in Groundbreaking Stem Cell Therapy

Featured and Top Image Courtesy of Berkshire Community College Open Bioscience Image Librarys Flickr Page Creative Commons License

alzheimers, FDA, spot, stem cell, Stem-cell Therapy, treatments

See the article here:
Stem Cell Therapy and Its Revolutionary Purposes Guardian ... - Guardian Liberty Voice

Canadian clinics begin offering stem-cell treatments …

Stem Cell Clinics | Posted by admin
Sep 03 2017

The arthritis in Maureen Munsies ankles was so intense until barely a year ago, she literally had to crawl on hands and knees to get upstairs.

The pain, she recalls now, took my breath away, and played havoc with the avid hikers favourite pastime.

In desperation, Munsie turned to a Toronto-area clinic that provides a treatment many experts consider still experimental, unproven and of questionable safety.

The 63-year-old says the stem cells she received at Regenervate Medical Injection Therapy 18 months ago were transformational, all but eliminating the debilitating soreness and even allowing her to hike Argentinas Patagonia mountains two months ago.

For me its been a life saver, Munsie says. Ive been able to do it all again I dont have any of that pain, at all.

Canadians drawn to the healing promise of stem cells have for years travelled outside the country to such places as Mexico, China or Arizona, taking part in a dubious form of medical tourism.

But Regenervate is one of a handful of clinics in Canada that have begun offering injections of stem cells, satisfying growing demand but raising questions about whether a medical idea with huge potential is ready for routine patient care.

Especially when those patients can pay thousands of dollars for the service.

Clinics in Ontario and Alberta are treating arthritis, joint injuries, disc problems and even skin conditions with stem cells typically taken from patients fat tissue or bone marrow.

The underlying idea is compelling: stem cells can differentiate or transform into many other types of cell, a unique quality that evidence suggests allows them to grow or regenerate tissue damaged by disease or injury.

Researchers including hundreds in Canada alone are examining stem-cell treatments for everything from ailing hearts to severed spinal cords.

With few exceptions, however, the concept is still being studied in the lab or in human trials; virtually none of the treatments have been definitively proven effective by science or approved by regulators like Health Canada.

The fact that Canadian clinics are now offering stem-cell treatments commercially is concerning on a number of levels, not least because of safety issues, says Ubaka Ogbogu, a health law professor at the University of Alberta.

Three U.S. women were blinded after receiving stem-cell injections in their eyes, while other American patients have developed bony masses or tumours at injection sites, Ogbogu said.

Stem cells have to be controlled to act exactly the way you want them to act, and thats why the research takes time, he said. It is simply wrong for these clinics to take a proof of concept and run with it.

Ogbogu says Health Canada must crack down on the burgeoning industry but says the regulator has so far been conspicuous by its inaction.

Other experts say the procedures provided here typically for joint pain are likely relatively safe, but still warn that care must be taken that the stem cells do not develop into the wrong type of tissue, or at the wrong place.

Alberta Health Services convened a workshop on the issue late last year, concluding there is an urgent need to develop a certification system for cell preparation and delivery to avoid spontaneous transformation of (stem cells) into unwanted tissue.

But one of the pioneers of the service in Canada says theres no empirical evidence that such growths can develop, and suggests the treatments only real risk as with any invasive procedure is infection.

Meanwhile, patients at Regenervate have enjoyed impressive outcomes after paying fees from $750 to $3,900, says Dr. Douglas Stoddard, the clinics medical director.

About 80 per cent report less pain, stiffness and weakness within a few months of getting their stem-cell injection, he said. His treatments efficacy, though, has not been tested in a randomized controlled trial, the gold-standard scientific study which would compare the injections to a sham or other treatment and identify any placebo effect.

I believe medical progress is not just limited to the laboratory and randomized double-blind trials, Stoddard said. A lot of progress starts in the clinic, dealing with patients You see something works, you see something has merit, and then its usually the scientists that seem to catch up later.

The Orthopedic Sport Institute in Collingwood, Ont., the Central Alberta Pain and Rehabilitation Institute and Cleveland Clinic in Toronto all advertise similar stem-cell treatments for orthopedic problems.

Edmontons Regen Clinic says it plans to start doing so this fall.

Ottawas Innovo says it also treats a range of back conditions with injections between the vertebrae, and uses stem cells to alleviate nerve damage.

Orthopedic Sport says its doctor focuses on FDA and Health Canada approved stem-cell injection therapy for patient care.

In fact, no treatment of the sort the clinics here provide has ever been authorized.

Health Canada says the vast majority of stem-cell therapies would constitute a drug and therefore need to be authorized after a clinical trial or new drug submission.

A number of stem-cell trials are underway, but only one treatment Prochymal has been approved, said department spokesman Eric Morrissette. Designed to combat graft-versus-host disease where bone marrow transplants for treating cancer essentially attack the patients body its unlike any of the services the stem-cell providers here offer.

But as the U.S. Food and Drug Administration aggressively pursues the hundreds of clinics in America, Health Canada says only that its committed to addressing complaints it receives.

It will take action based on the risk posed to the general public, said Morrissette, who encouraged people to pass on to the department information about possible non-compliant products.

Stoddard said the injections his clinics provide are made up of minimally manipulated tissue from patients own bodies and any attempt to crack down would be regulation for the sake of regulation.

But academic experts remain skeptical about the effectiveness of the treatments.

Scientific evidence suggests the injections may help alleviate joint pain temporarily, but probably just because of anti-inflammatory secretions from the cells not regeneration, said Dr. David Hart, an orthopedic surgery professor at the University of Calgary who headed the Alberta workshop.

Theres a need for understanding whats going on here and theres a need for regulation, he said.

Most of the clinics say they use a centrifuge to concentrate the stem cells after removing them from patients fat tissue or bone marrow. But its unclear if the clinics even know how many cells they are eventually injecting into patients, says Jeff Biernaskie, a stem-cell scientist at the University of Calgary.

Munsie, on the other hand, has no doubts about the value of her own treatment, even with a $3,000 price tag.

The procedure from extraction of fat tissue in her behind to the injection of cells into her ankles took barely over an hour.

Within three months, the retired massage therapist from north of Toronto says she could walk her dogs again. Last week, she was hiking near Banff.

Im a real believer in it, and the possibility of stem cells, says Munsie. I just think Wow, if we can heal with our own body, its pretty amazing.

(The story was modified July 6 to clarify lack of clinical-trial evidence for Regenervate procedures.)

More here:
Canadian clinics begin offering stem-cell treatments ...

FDA cracks down on clinics selling unproven stem cell therapies – Gears Of Biz

Stem Cell Clinics | Posted by admin
Sep 03 2017

The US Food and Drug Administration (FDA) yesterday targeted a booming national market for suspect medical treatments, announcing actions against clinics offering questionable stem-cell treatments for cancer and other diseases.

The FDA moved against California Stem Cell Treatment Centers in Beverly Hills and Rancho Mirage; StemImmune Inc of San Diego; and the US Stem Cell Clinic of Sunrise, Florida.

In what it termed as decisive action to protect patients, the FDA on Friday dispatched US marshals to the California clinics and seized close to 500 doses of smallpox vaccine supplied by StemImmune. The vaccine was to be mixed with stem cells taken from patients body fat, for direct injection into patients malignant tumors.

According to the FDAs statement issued Monday, this is an unapproved and potentially dangerous treatment for cancer.

Of the five vials of vaccine, one had been opened and was partially used, the FDA said.

According to the agency, the seizure of the smallpox vaccine was necessary to prevent the use of a potentially dangerous and unproven treatment.

The FDA said it would investigate how StemImmune Inc came to be in possession of the smallpox vaccine, which is not commercially available and is normally reserved for people who are at risk of exposure to smallpox, such as military personnel and healthcare workers.

Meanwhile, the FDA said in a press release, As the vaccine is not commercially available, the FDA has serious concerns about how StemImmune obtained the product for use as part of an unapproved and potentially dangerous treatment. The FDA is actively investigating the circumstances by which StemImmune came to possess the vaccine.

Speaking as a cancer survivour, I know all too well the fear and anxiety the diagnosis of cancer can have on a patient and their loved ones and how tempting it can be to believe the audacious but ultimately hollow claims made by these kinds of unscrupulous clinics or others selling so-called cures, said FDA commissioner Scott Gottlieb, MD.

The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work. I especially wont allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse.

The seizure comes after recent FDA inspections at StemImmune Inc and the California Stem Cell Treatment Centers confirmed that the vaccine was used to create an unapproved stem cell product (a combination of excess amounts of vaccine and stromal vascular fraction stem cells derived from body fat), which was then administered to cancer patients with potentially compromised immune systems and for whom the vaccine posed a potential for harm, including myocarditis and pericarditis (inflammation and swelling of the heart and surrounding tissues). The unproven and potentially dangerous treatment was being injected intravenously and directly into patients tumors.

Serious health problems, including those that are life-threatening, can also occur in unvaccinated people who are accidentally infected with the vaccinia virus by being in close contact with someone who has recently received the vaccine. In particular, unvaccinated people who are pregnant, or have problems with their heart or immune system, or have skin problems like eczema, dermatitis, psoriasis and have close contact with a vaccine recipient are at an increased risk for inflammation and swelling of the heart and surrounding tissues if they become infected with the vaccine virus, either by being vaccinated or by being in close contact with a person who was vaccinated.

Ive directed the agency to vigorously investigate these kinds of unscrupulous clinics using the full range of our tools, be it regulatory enforcement or criminal investigations. Our actions today should also be a warning to others who may be doing similar harm, we will take action to ensure Americans are not put at unnecessary risk, Gottlieb added. I also urge health care providers, patients and consumers to report these kinds of activities or any adverse events associated with these unproven treatments to the agency through MedWatch.

Original post:
FDA cracks down on clinics selling unproven stem cell therapies - Gears Of Biz

FDA to crack down on ‘unscrupulous’ stem cell clinics …

Stem Cell Clinics | Posted by admin
Aug 31 2017

FILE -- The Sawgrass Medical Center, where the U.S. Stem Cell Clinic operates, in Sunrise, Fla., March 15, 2017. The Food and Drug Administration issued a warning letter to U.S. Stem Cell and announced a crackdown on other dangerous stem cell clinics, while at the same time pledging to ease the path to approval for companies and doctors with legitimate treatments in the growing field. (Scott McIntyre/The New York Times)

The U.S. Food and Drug Administration on Monday promised a nationwide crackdown on unscrupulous stem cell clinics, following years of reports that some clinics have offered lofty claims of potential medical benefits with scant, if any, medical evidence.

These dishonest actors exploit the sincere reports of the significant clinical potential of properly developed products, as a way of deceiving patients and preying on the optimism of patients facing bad illnesses. This puts the entire field at risk, wrote FDA Commissioner Dr. Scott Gottlieb, who was appointed in May. Products that are reliably and carefully developed will be harder to advance if bad actors are able to make hollow claims and market unsafe science.

Gottliebs statement, published Monday on the FDAs website, highlighted a warning letter issued to one Florida stem cell clinic on Thursday and the direct seizure of products from another clinic in California on Friday. Gottlieb said the agency is aware of other cases where unproven stem cell treatments have clearly harmed patients, and he promised additional enforcement actions in the coming months.

View original post here:
FDA to crack down on 'unscrupulous' stem cell clinics ...

FDA cracks on clinics using unapproved stem cell treatments – Pulse Headlines

Stem Cell Clinics | Posted by admin
Aug 29 2017

The U.S. Food and Drug Administration (FDA) said on Monday that it would take severe measures after it found that clinics around the country are selling unapproved and potentially dangerous stem cell treatments to patients with cancer and other hard diseases, according to a warning letter posted by the agency.

The crackdown was announced due to hundreds of clinics around the country selling unapproved stem cell therapies, but two of them were specifically pointed: the U.S. Stem Cell Clinic of Sunrise, Florida; and California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills. In the last one, certain doctors carried out a surgery where they injected a smallpox vaccine intravenously and directly to the patients tumors.

Many of these patients have suffered great harm, and even death as a result of using unproven stem cell therapies, the President of the International Society for Stem Cell Research, Hans Clevers, said in a statement. We are hopeful that increased regulatory enforcement against clinics offering unproven treatments will deter this practice and help protect patients.

On Monday, the FDA posted on its web page a warning letter sent last week to U.S. Stem Cell Clinic of Sunrise, Florida. In it, the agency condemned the selling of unapproved stem cells treatments, which doctors injected intravenously and directly into the patients spines. Previously, according to a report published by the New England Journal of Medicine, this Florida clinic was already linked with three women who ended up blind after they were subjected to a fat-stem cell treatment for macular degeneration.

However, this is just one of many other clinics around the country that the agency accused to use stem cells vaccines to treat different conditions, such as cancer, Parkinsons disease, amyotrophic lateral sclerosis (ALS), and lung and heart diseases.

Along with it, on the same Monday, the agency announced that last week it accused StemImmune Inc. of San Diego to purchase five live virus vaccine vials, previously designated to only those patients who were at high risk of smallpox. At the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, the vaccines were later combined with stem cells extracted from patients fat and injected directly to patients tumors.

Ive directed the FDA to launch a new working group to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health, The FDA commissioner, Dr. Scott Gottlieb wrote in a statement. We have examples where some of these unproven treatments have clearly harmed patients.

Doctors might offerunapproved stem cells therapies, and people under high-risk diseases might accept them without having a second thought. This is why the FDA published a series of advice for safe before they choose an unproved and dangerous treatment instead of a secure and adequate therapy.

If you see a business thats making all sorts of dramatic marketing claims across disease categories, claiming to use fat as a treatment for all sorts of indications, these are all signs to be wary of, said Leigh Turner, associate professor at the Center for Bioethics at the University of Minnesota.

According to Turner, it is not easy for patients to either recognize which treatment would be good and beneficial for them, or which one would be totally dangerous.

Source: CNN

Read more:
FDA cracks on clinics using unapproved stem cell treatments - Pulse Headlines

FDA cracks down on clinics selling unapproved stem cell therapies – CBS News

Stem Cell Clinics | Posted by admin
Aug 29 2017

The U.S. Food and Drug Administration announced a crackdown on stem-cell clinics marketing and selling unapproved and potentially harmful therapies for cancer and other diseases.

The agency took action against two large clinics in Florida and California, which have started selling treatments that the agency says use stem cells but have not been approved as safe and effective by the FDA.

"A small number unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products," FDA Commissioner Scott Gottlieb, M.D., said in a statement.

The FDA issued a warning letterto US Stem Cell Clinic of Sunrise, Florida, after an inspection in which the agency found that the clinic was processing body fat into stem cells and administering the product both intravenously or directly into the spinal cord of patients with Parkinson's disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease and pulmonary fibrosis.

"The FDA has not reviewed or approved any biological products manufactured by US Stem Cell Clinic for any use," the agency said in a statement.

During the inspection, investigators also reported the clinic deviated from guidelines put in place to prevent microbiological contamination, which puts patients at risk for infections, the agency said.

Also this week, the FDA seized five vials of a smallpox vaccinefrom StemImmune Inc. in San Diego, California, which the agency said was used to create an unapproved treatment of stem cells and excess amounts of the vaccine, which was then administered to cancer patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California.

The FDA says this treatment put patients at risk for potential harms including inflammation and swelling of the heart and surrounding tissues.

The agency said it will investigate how StemImmune Inc. obtained the vials of the vaccine, which each contained 100 doses. The vaccine is not commercially available and is reserved only for people considered at high risk for smallpox, such as some members of the military. One vial was partially used, while four of the vials were still intact, the FDA reports.

"I've directed the agency to vigorously investigate these kinds of unscrupulous clinics using the full range of our tools, be it regulatory enforcement or criminal investigations. Our actions today should also be a warning to others who may be doing similar harm, we will take action to ensure Americans are not put at unnecessary risk," Gottlieb said.

In response, Dr. Mark Berman, co-founder of the California Stem Cell Treatment Centers, told the Los Angeles Times that the comments from the FDA are "disparaging and misrepresentative," and said they showed "a lack of understanding" of surgical procedures in which patients' own stem cells are used to promote regeneration.

Berman, who is also director of stem cell implantation at StemImmune, called the clinic's products "cutting edge cancer therapy" for Stage 4 cancer patients, the Times reports.

US Stem Cell Clinicposted a response to its website, saying, "The safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws of the Food and Drug Administration."

"The FDA has stated that they will have specific stem cell guidelines by the 21st Century Cures Act deadline of December 13, 2017 and we intend to follow those standards as well," the statement continues. "We have helped thousands of patients harness their own healing potential. It would be a mistake to limit these therapies from patients who need them when we are adhering to top industry standards."

More here:
FDA cracks down on clinics selling unapproved stem cell therapies - CBS News