FDA cracks down on stem cell clinics offering unproven therapies

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The sleek website for the Gulf Coast Stem Cell Treatment Center in Ocean Springs boasts about its “life-altering” stem cell therapies that treat more than two dozen maladies, from multiple sclerosis and lung disease to lupus and joint pain.

Last year, nearly 250 people sought out the center, which advertises a set price of $7,200 for the first round of stem cell injections. During an initial phone call, a coordinator explains that most patients will have to pay this out of pocket. Insurance won’t cover any of the center’s stem cell therapies because, as its website says in a disclaimer, none of these treatments has been approved by the Food and Drug Administration — or even deemed effective.

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The Gulf Coast Stem Cell Treatment Center is one of 570 clinics across the country marketing expensive stem cell therapies directly to customers, despite a lack of scientific evidence that these therapies work, according to a paper published this summer in the journal Cell Stem Cell. Last month, the FDA held a public hearing on the regulation of stem cells at the National Institutes of Health, where many scientists called on the government agency to clamp down on for-profit clinics offering unproven therapies.

Dr. Vincent Herrin

Dr. Vincent Herrin

“It’s not harmless,” said Dr. Vincent Herrin, associate professor and member of the Hematology Care Team at University of Mississippi Medical Center, which is the sole stem cell operation in the state accredited by the Foundation for Accreditation of Cellular Therapy. “It’s important in medicine to follow proven therapies, or if there’s something experimental it needs to be done through an established clinical trial so … the patient is better protected that way.”

Currently, the only approved treatments with adult stem cells in the U.S. involve taking stem cells from bone marrow or blood to treat patients with certain cancers and other disorders, according to Dr. Jack Mosher, scientific affairs manager at the International Society for Stem Cell Research. These treatments have undergone a number of rigorous, independent clinical trials, he said. Those labeled “unproven” or “experimental” have not.

But some of the most vocal resistance to the FDA’s scrutiny of these clinics has come from patients themselves. During last month’s FDA hearings, patients gave emotional testimonies about how these therapies had allowed them to live normal lives. The Facebook page of Gulf Coast Stem Cell receives 4.9 stars out of five from patients claiming the stem cell treatments have cured everything from lung disease to multiple sclerosis.

One of the women who left a five-star review is Terrie Kieper, 47, of Dallas, who was diagnosed with MS in 2007. She said Dr. Hazem Barmada, who runs Gulf Coast Stem Cell, “saved (her) life.”

On a recent phone call with a reporter, she enthusiastically ticked off the ways her life has changed, all while driving, one of the many activities she said she had given up before her first stem cell transfer in November 2014. Back then, she said, three shelves of her kitchen cupboard were devoted to pills just to get her through the day.

“Just off the top of my head I was on my (MS) modifying medication Copaxone. I was on Gabapentin, that’s for tremors, Xanax, hydrocodone, Valium for vertigo, I was on Nuvigil for fatigue, I was on Ambien CR. I was on Zomig for migraines and there was another migraine medication, too,” Kieper said. “I said ‘I’m going to do this or I need a bullet and a gun. Because I can’t continue on the way I have.’”

Two years and two stem cell treatments later, Copaxone is the one prescription medicine she takes.

“When people ask me about Dr. Barmada – it’s so hard to explain what gratitude I have for them. He saved my life,” Kieper said. “I was in so much pain. I just existed.”

Barmada is full of anecdotes about other patients like Kieper. But if these therapies do work, he is at a loss to explain exactly how they do.

Dr. Hazem Barmada

Mississippi Stem Cell Treatment Center

Dr. Hazem Barmada

“If I feel I’m benefiting someone and they have no light at the end of the tunnel otherwise, I do it,” Barmada said. “Can I explain it? No, I cannot. I really cannot explain it, and I’m still scratching my head. So is it not true? Well, it is true. And I accept it.”

Until about three weeks ago, Mississippi had a second stem-cell treatment center offering orthopedic therapies. But shortly after the FDA held its hearings, Bienville Orthopaedic Specialists, also in Ocean Springs, temporarily suspended its stem-cell treatments and removed information about them from its website. A spokesperson for Bienville said she did not know whether it was due to the increased FDA scrutiny but said these treatments were never a significant part of Bienville’s business.

“It’s not to say that our doctors won’t take it back up, but currently it’s off the table,” said Erica Shrock, director of marketing for Bienville.

Because of their remarkable regenerative powers, stem cells have seized people’s imaginations in the past decade. And these “experimental” clinics have capitalized on this, according to Mosher. Since 2007, more than a dozen stem cell treatment centers have opened in neighboring states, including two in Alabama, three in Tennessee and eight in Arkansas.

Dr. Jack Mosher

Dr. Jack Mosher

But Mosher said the publicity has confused people about what, exactly, stem cells can do. Many of the restorative properties people attribute to all stem cells are actually specific to embryonic stem cells, which are highly controversial, highly regulated and very rare in the United States.

Adult stem cells, while less regulated, are very limited in the types of tissues they can regrow.

“(A bone marrow) stem cell, for example, is immature. It can turn into a variety of different blood cells, but it doesn’t turn into brain tissue or kidney tissue or nerve tissue,” Herrin said. “So the stem cells harvested from adults can’t just turn into anything. But I think people think they (can).”

And, according to Mosher, that’s what these clinics are banking on.

“It should be a red flag when the clinic is making claims that a single type of stem cell will treat over 20 different diseases, that span different systems — neurological, urological,” Mosher said. “So if they’re offering one type of stem cell, for example taking the fat from someone’s love handles and making the claim that it’s going to treat ALS, it’s going to treat COPD (chronic obstructive pulmonary disease), it’s going to treat autism, there’s just no scientific support for those types of claims.”

Like many clinics mentioned in the FDA hearing, the Mississippi Stem Cell Treatment Center uses stem cells harvested from fat. But Barmada said that despite a lack of scientific evidence for his therapies, he still believes in their power to heal.

Still, less than two hours after Mississippi Today reached out to the center, it launched a redesigned website now clarifying its stem cell therapy as “investigational” and claiming it “May promote healing and tissue generation” (emphasis theirs).

Barmada said the site’s language and design were already scheduled to be updated that week.

Although these therapies are not FDA-approved, they aren’t illegal, either. They currently rely on a loophole in FDA regulations that classifies treatment with a patient’s own tissue as a surgical procedure and not a drug.

But this loophole might be closing. In order for the treatment to fall within FDA guidelines, the cells must be, among other things, injected into the same part of the body they were taken from.

“So very simplistically, if they’re taking fat from your body they need to use it in fat,” Mosher said.

In December, the FDA issued a warning letter to the Irvine Stem Cell Treatment Center, then an affiliate of the Cell Surgical Network, of which Gulf Coast Stem Cell is also a member. Violations included improperly using adipose-derived fat cells, which is the same method used by Gulf Coast Stem Cell and many of the 83 other clinics in the Cell Surgical Networks.

Another caveat on Gulf Coast Stem Cell’s website is that these treatments are patient funded clinical trials. Barmada said he posts his results on clinicaltrials.gov, which is run by the National Institutes of Health. A search did not turn up any of his trials, but a trial from the Cell Surgical Network was listed. Still, Mosher stressed that posting data does not turn a treatment into a clinical trial.

“There is no regulation or oversight on that space,” Mosher said. “When clinics say they’re registered at (National Institutes of Health) that’s not a threshold for legitimacy. Anything can be posted there.”

Mosher said that some legitimate clinical trials are being run on the types of therapies offered at these clinics, but it’s hard to look at the website and tell which is which. As a result, it’s impossible to quantify how well the therapies offered at these clinics are working.

“That’s part of the problem with the absence of clinical data. Is it a one-off? Is it a placebo? It’s hard to tell. It’s just hard to know.”

Barmada said he agrees. He argued that increased FDA scrutiny will only help his business and other similar stem-cell treatment centers.

“I think people very often misunderstand the feelings of people like me towards the FDA,” Barmada said. “I believe the FDA is there for my protection. I do not fear the FDA, and I think there is plenty of room for us to work together … and I think myself and my colleagues are really happy to work with the FDA.”

Despite his reservations about clinics offering these stem cell treatments, Mosher can sympathize with patients willing to spend thousands of dollars on an unproven therapy.

“Many of them have the mindset that if there’s a sliver of hope, it’s worth it. But in many cases they may be paying for treatments that just have no sound scientific support that they’re going to work. And they won’t work.”

  • don margolis

    Pharma owns 99% of the doctors in this corrupt medical system, doctors who are either totally ignorant of the truth about stem cells or are handsomely bribed. Just so your readers know the truth with this fact, which no publication getting Pharma advertising is allowed to print: THERE ARE 988 SUCCESSFUL COMPLETED CLINICAL TRIALS USING ADULT STEM CELLS AGAINST MANY DIFFERENT DISEASES….ALL.REGISTERED AT THE NIH. But Pharma owns them and they make the silly statements found at the beginning of your balanced article.
    Your doctors make their money pushing toxic drugs, the vast majority of which have 987 fewer clinical trials behind them than Adult Stem Cells. Several have no trials. But the FDA is owned by Pharma and by law CANNOT RELEASE TO THE PUBLIC THE DRUG TRIAL RESULTS. And the drug companies release the good news and hide the bad news until a hundred or so die. And that is all our MDs are allowed to know.

  • icicle

    It is fairly obvious the writer here has little knowledge of either medicine or law :/ The article is as bogus as the fake news below it – “Jaclyn Smith is totally unrecognizible today”.

    For the record, embryonic stem cells are never used as they have the potential to turn into anything, given the wrong signal. Stem cells that are closer to the required tissue type are used instead, which is why some treatments use autologus fat, some bone marrow derived cells. Stem cell treatment, while not quite as old as leeches has been used widely since the 1960’s. We didn’t call it ‘stem cell treatment’ we called it ‘bone marrow transplant’ and no-one knew how or why it worked. Only that it did.

    We do know how it works now and there are hundreds of studies in humans and animals for bone marrow and adipose derived (‘fat’) cells. You can read them on Pubmed. What we have here is an cosy little industry making more money keeping people sick. Remember the Ford Pinto? Our corporate Lords and Masters WILL kill us if they can make 50c extra.

    Jaclyn Smith looks about 10 years older than she did in 1978.