‘Stem cell snake oil’ clinics

‘Stem cell snake oil’ clinics could put patients in danger, report[1] says

Study finds that at least 350 companies are marketing unapproved stem cell ‘treatments’ aimed at everything from facelifts to Alzheimers and Parkinson’s

The US has become a booming market for unauthorized stem cell “treatments” for everything from breast enhancements to Alzheimer’s disease, according to the authors of a new report that warns of dangers to patients from such “stem cell snake oil” pitches.

At least 351 companies are marketing unapproved stem cell procedures at 570 clinics, according to the study reported in the journal Cell Stem Cell.

Many such businesses promise treatments for a wide range of diseases and injuries, sometimes listing as many as 30 or 40 conditions including sports injuries, spinal cord damage, immune diseases, lung disorders and neurological diseases such as Parkinson’s and Alzheimer’s.

Cosmetic clinics offered “stem cell facelifts”, “stem cell breast augmentation” and “stem cell buttock enhancement”, the report found. A handful of clinics offered more exotic fare, such as “embryonic stem cell” interventions and “bovine amniotic cells” – allegedly cow cells to be used in humans.

“A phrase like ‘stem cell snake oil’ certainly flashes to mind for some of these clinics,” Leigh Turner, professor of bioethics at the University of Minnesota and co-author of the study with Paul Knoepfler, a professor at UC Davis School of Medicine in Sacramento, said.

“You have these businesses promoting anti-aging, longevity, restoration of youth, that you can ‘come to our place and feel younger, look more vibrant.’ There’s the sexual enhancement dimension,” he said.

Turner said that before taking on the comprehensive study, he sent the US Food and Drug Administration (FDA) detailed letters “numerous times”, warning about specific businesses.

“These are pretty dramatic claims, for treating ALS, for Parkinson’s, and when you look, is there an experienced stem-cell researcher there? No. Is there any record of previous research trials? No. Any phase one, phase two trials? No.

“They’re basically operating off the grid, in terms of anything resembling meaningful transitional research.”

The findings come less than three months before a planned FDA public hearing on the regulation of stem cell treatments.

The FDA is looking to crack down on such businesses and recently issued draft guidelines on how stem cells must go through a rigorous approval process before being used to treat patients.

Critics like Turner and Knoepfler have called for more evidence on the efficacy of such treatments. Some patients, however, say they should be allowed to use their stem cells how they want. Such tensions are expected to come to a head at an FDA public hearing in September.

In a statement, the agency said: “The FDA is concerned that the hope patients have for treatments not yet proven to be safe and effective may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful.”

Turner and Knoepfler hope their work can be used as a resource to help the FDA to target the clinics with the most egregious practices.

They found information on such clinics by searching on the internet for advertised stem cell therapies, then recording company names and marketing claims. They said the report aimed to help fill the “urgent need” for more information on such businesses.

Clinics advertising stem cell therapies are most likely to be found in California, Florida, Texas, Colorado, Arizona and New York, according to Turner and Knoepfler. Beverly Hills was found to have more such clinics that any other US city, with 18.

The researchers said they planned to investigate why such businesses cluster in such areas and suggested it could be because of demographics, state medical regulations and the popularity of “alternative” medical therapies.

Turner said there were varied dangers inherent to “unapproved human experimentation” packaged as treatment and without scientific evidence or even warnings.

“In a way people are almost uninformed and unwitting guinea pigs,” he said. “They are research subjects but no one is telling them that.”

He noted that there are dangers even to stem cell treatments which have a solid research basis, like bone marrow transplants, and that controversial stem cell clinics have been linked to devastating and even fatal cases.

Patients who pursue these unregulated treatments also put themselves at huge financial risk, Turner said, potentially spending $10,000 to $20,000 on an “expensive placebo effect”.

Alan Yuhas and Amanda Holpuch in New York Thursday 30 June 2016 18.16 BST

  1. Leigh Turner, Paul Knoepfler. Selling Stem Cells in the USA: Assessing the Direct-to-Consumer Industry. Cell Stem Cell. Full Text


Unregulated stem-cell clinics are proliferating across the United States

By Laurie McGinley June 30 at 5:44 PM

For years, American “stem-cell tourists” have flocked to unregulated clinics in Mexico, the Caribbean and China in search of everything from heart treatments to facelifts. But now, these kinds of clinics are popping up across the United States.

According to a new study, at least 351 companies with 570 clinics are marketing unapproved treatments for conditions such as osteoarthritis, Alzheimer’s, autism and injured spinal cords, as well as for cosmetic enhancements.

“In almost every state now, people can go locally to get stem-cell ‘treatments,’ ” said Paul Knoepfler, a stem-cell scientist at the University of California at Davis School of Medicine and one of the authors of the study, published Thursday in the journal Cell Stem Cell. “That’s different from what we typically think about when we think of stem-cell tourism.”

Knoepfler and his co-author, Leigh Turner, associate professor at the Center for Bioethics at the University of Minnesota, didn’t accuse the clinics of operating illegally but called on federal officials to step up their oversight. “What worries us is the possibility of serious harm to patients,” Turner said.

Stem cells are a source of keen interest because they can be coaxed into becoming almost any type of cell and thus might offer remedies for many medical problems. But they also carry risk: They can form tumors and migrate to parts of the body where they don’t belong.

For the study, the researchers scoured the Internet for businesses engaged in direct-to-consumer marketing of stem-cell procedures. Many of the clinics were in California (113), Florida (104) and Texas (71). Certain cities, including Beverly Hills, New York and San Antonio, were “hot spots.” Almost two-thirds of the businesses offered procedures involving stem cells derived from a patient’s own fat; almost half performed treatments using bone marrow.

The Food and Drug Administration has approved only a few stem-cell treatments. In the vast majority of cases, the procedures being conducted in the clinics are not approved, are outside clinical trials and can cost patients thousands of dollars.

The new analysis comes as the debate over regulating stem-cell clinics is intensifying. While some critics say the FDA should crack down on the industry, others say the clinics shouldn’t face new restrictions because what they are doing is part of the “practice of medicine.”

Michael Werner, executive director of the Alliance for Regenerative Medicine, which represents companies, patient advocates and researchers, said his group thinks FDA oversight is critical. He said “the proliferation of the so-called stem-cell clinics is potentially harmful because the treatments may not undergo, or have not undergone, the appropriate scientific rigor that takes place in evaluating new technologies and new medical treatments.”

But Marc Scheineson, a former top FDA official who advises the Bipartisan Policy Center on medical innovation, said the current FDA regulatory regime is “archaic” and is stifling medical innovation.

Some Republicans in Congress are pushing a bill that would allow the FDA to approve stem-cell treatments for five years without advanced clinical trials.

As the issue heats up, the FDA has scheduled two public meetings in September to get public comment on draft guidance language on stem cells.

In a statement, the agency said, “In theory, stem cells may advance the treatment of many other diseases or conditions; however, at this time, the value of stem cells as a treatment for most conditions is largely unproven and more information is needed about their potential benefits.”

The agency added that it is “concerned that the hope patients have for treatments not yet proven to be safe and effective may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful.”

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