Following growth of ‘stem cell clinics,’ FDA poised to crack down

    A bone marrow harvest. (<a href=Photo via Wikimedia Commons)" title="021204-N-0696M-180" width="640" height="360"/>

    A bone marrow harvest. (Photo via Wikimedia Commons)

    Patient advocacy groups and experts are at odds over unapproved stem cell treatments. 

    Smack dab at the top of the homepage for the California-based company StemGenex, there’s a video testimonial. It stars Sharon and Warren Hudson, who explain how stem cell therapy reversed some of the damage caused by Parkinson’s Disease.

    “When StemGenex came into the picture, suddenly there was the discussion of getting better,” says Warren. “It was the discussion of finding ways to alleviate the symptoms.”

    The couple detail how the procedure eased Warren’s mobility issues, and allowed him to continue driving.

    “Let me tell you that there is hope out there, and that there are so many ways that the treatment can help you,” explains Sharon. “And we are living proof.”

    The Hudsons clearly believe in stem cell therapy, and they aren’t alone. But actual proof, from randomized clinical trials — the type of evidence we demand for other drugs — doesn’t yet exist.

    Some background here: These are not the controversial kind of stem cells that are harvested from embryos.

    These cells are instead usually extracted from the patient’s own fat through liposuction, or from bone marrow. They’re then isolated and reinjected into a joint or the blood stream, where in theory they do what stem cells are so valued for doing: regenerate, and replace damaged tissue.

    Without FDA approval, patients like Warren Hudson used to have to travel overseas as medical tourists to access unproven treatments. But what some call a loophole in U.S. regulations is allowing clinics to pop up across the country, with more than 500 facilities now marketing these treatments directly to patients.

    Joshua Graff Ziven is a researcher with U.C. San Diego. He likens the rapid growth of these clinics in the past few years to medicine’s ‘Wild West.’

    “In essence, I can put out my shingle and offer certain types of stem cell treatments, and I can claim that they cure anything from joint disease to MS to Parkinson’s, without there being any real scientific evidence to substantiate that claim,” he says.

    The list of supposed cures goes on and on, from reversing Alzheimer’s and arthritis to augmenting buttocks and ending male pattern baldness — all advertised as possible with stem cells.

    Because they are your own cells and claimed to be minimally altered, the FDA has been slow to regulate.

    “And if you look at the websites of these organizations, and you look at the claims of these organizations, they are really quite deceptive,” says Graff Ziven. “And so I am very dubious that patients that go to get their joint pain treated at a stem cell clinic really understand how much of a crapshoot they’re undertaking when they go to that clinic and drop $10,000 or $15,000 or $20,000.”

    That gamble isn’t just if the treatment will yield results. Even though they’re marketed as safe by many clinics, some patients have had negative reactions.

    Charles Krome is a sports medicine physician with a practice in southern New Jersey, where he offers stem cells for joint ailments. Krome says he sees results, but is upfront with patients about the risks and unknowns. He worries others in his field aren’t doing the same.

    “In any profession, there are good and bad. There are good presidents and bad presidents, there are good lawyers and bad lawyers, good doctors, bad doctors,” says Krome.

    “Unfortunately, there are physicians in this country and throughout the world who are making claims about stem cells that just aren’t scientifically proven. And it is unfortunate because they kind of ruin it for the rest of us.”

    The FDA is holding public hearings later this month on proposed new guidelines that could crack down on direct-to-consumer clinics. But some patient advocacy groups are opposed, saying stem cells offer hope when they’ve exhausted other options, and that they can’t wait the decade-plus it takes for pharmaceuticals to work their way through the standard approval process.

    “One-hundred percent. I know that this is something that’s helped me, and I really do think it should be available to people across the board,” says Jennifer Ziegler, with the group Patients for Stem Cells.

    She’s undergone stem cell treatments on three separate occasions, and each time, she says she experienced symptom relief. She bristles at the thought of the FDA limiting her access.

    “This is between one patient and one doctor. And we don’t consider the cells in our bodies to ever have been a drug,” says Ziegler.

    To that end, there is federal legislation pending separate from the FDA hearings that seeks to fast track stem cell clinical trials. Janet Marchibroda is with the Bipartisan Policy Center, a think-tank which supports the measure.

    “The bottom line for all of us working in this field is that we want patients in need in the United States to have access to safe and effective cell therapies. And we want patients to be protected from unsafe therapies,” she says.

    There is clearly a balance to strike here between protecting patients without stifling medical innovation. What’s unclear, though, is how direct-to-consumer clinics, which offer hope but limited proof, fit into that calculation.

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