The Federal Trade Commission (FTC) announced last week that it has settled deceptive advertising charges against a California physician and two companies he operates based on their claims that “amniotic stem cell therapy” can treat a number of serious diseases and conditions, including Parkinson’s disease, autism, macular degeneration, cerebral palsy, multiple sclerosis, osteoarthritis, strokes, chronic kidney disease, and cardiovascular disease. The FTC noted two particularly egregious claims advertised on the defendants’ website, one boasting that that their stem cell therapy could restore the vision of blind patients, including a “101 year old Lady once blind for 7 years” and another claiming that they could “reverse autism symptoms.”
According to the FTC’s complaint, Bryn J. Henderson, D.O., J.D., and the two companies he owns and operates, Regenerative Medical Group and Telehealth Medical Group, earned at least $3.31 million offering stem cell therapy between 2014 and 2017. Initial stem cell therapy injections ranged from $9,500 to $15,000, and patients were encouraged to undergo multiple treatments. Follow-up “booster” treatments cost between $5,000 and $8,000 each.
The complaint, which contains a number of screenshots from a website and other media demonstrating the false treatment claims, alleges Dr. Henderson was aware that “the vast majority of amniotic stem cell research has been conducted on animal models.” As well,
There are no human clinical studies in the scientific literature showing that amniotic stem cell therapy cures, treats, or mitigates diseases or health conditions in humans, and the medical community considers amniotic stem cell therapy to be an experimental and unproven treatment. He also has not conducted any studies demonstrating that amniotic stem cell therapy cures, treats, or mitigates diseases or health conditions in humans.
The settlement, embodied in a proposed order which must be approved by the federal district court, prohibits Dr. Henderson and his companies from misrepresenting that any product or service (1) cures, mitigates, or treats any disease or health condition, or (2) that they are comparable to, or better than, conventional medical treatments, unless these claims are true and can be supported by “competent and reliable scientific evidence,” the FTC’s standard for advertising health claims.
The proposed order also imposes a $3.31 million judgment against the defendants, which is partially suspended pending payment of $525,000 to the FTC and compliance with the settlement’s terms. The FTC can use this money to provide refunds to consumers harmed by the defendants’ conduct.
The settlement requires the defendants to send a specifically-worded notice to current and former patients confessing that the FTC, described as “the nation’s leading consumer protection agency,” has told them to stop making “promises that our stem cell therapy treats a variety of serious diseases and health conditions” because the FTC
says these claims are not currently backed by competent and reliable scientific evidence. Therefore, we can’t make these claims in the future unless they can be supported by scientific proof.
A suggestion that the patient call his lawyer would be superfluous.
No actual stem cells in amniotic stem cell treatments
According to critics, amniotic stem cell treatments are promoted by physicians, chiropractors and naturopathic doctors, including at seminars where participants are encouraged to sign up on the spot. But, as they point out, there are no actual live stem cells in “amniotic stem cell treatments.” Amniotic stem cells are harvested from the placenta of volunteers immediately after giving birth. However, once this tissue is cryopreserved (i.e., freeze-dried), no stem cells survive. (SBM’s Harriet Hall has blogged about chiropractic amniotic stem cell treatments and David Gorski about naturopathic stem cell treatments, two among the many SBM blog posts on the subject of stem cells.)
The FTC apparently chose ignore this particular issue, banking instead on the fact that there is no reliable scientific evidence to support the defendants’ advertised claims for amniotic stem cell treatments, whether they contain any stem cells or not. Given how straightforward the proof of the FTC’s position would be — No papers? No trials? No evidence! — there was no need to complicate things.
(I should note that some critics of so-called “amniotic stem cell treatments” promote freeze-dried amniotic product as beneficial for orthopedic uses, although not on the basis of its containing live stem cells, which, they say, it most certainly does not. Whether there is sufficient evidence for those treatments is beyond the scope of this post.)
Paul Knoepfler, Ph.D., an expert on stem cells (and guest SBM blogger) is also dismissive of “amniotic stem cell therapy,” referring to it, in his own blog post on the FTC settlement, as “whatever that happens to actually be at any particular clinic.”
A regulatory dumpster fire
While critics of unproven stem cell treatments like Dr. Knoepfler have applauded the FTC’s action, the fact remains that regulation of stem cell clinics is something of a dumpster fire.
The FDA must approve “stem-cell based products”, unless they are being studied in an Investigational New Drug Application submitted to and allowed to proceed by the FDA. Approved stem cell products (listed here) are currently limited to blood-forming stem cells derived from cord blood approved for limited use in patients with hematopoietic disorders.
But, while the FDA has laid claim to regulatory authority over all biologic products, including stem cells, there is a big tug-of-war going on between stem cell clinics and the agency over just how far that authority extends. Some physicians, for example, argue that extracting stem cells from a patient, processing them, then re-injecting the patient’s own cells back into his body, is the practice of medicine, not the manufacture of a new biologic product and therefore not within the FDA’s purview. In between lie definitional battles over how much processing is required to transform a medical procedure into a biologic product (more than “minimal manipulation,” according to the FDA) and the intended use of the processed stem cells (e.g., whether the use is “homologous,” again according to the FDA). I highly recommend Dr. Knoepfler’s guest post for a better and much more detailed explanation of this minefield (note that some of the proposed FDA guidance he discusses has since been finalized).
In any event, in the midst of this regulatory uncertainty, hundreds of stem cell clinics have sprung up in the U.S., many offering unproven treatments, sometimes under the guise of doing a “clinical trial”. JAMA has published not one, but two, articles this year cataloguing the many crowdfunding requests asking donors to contribute to patients seeking unproven stem cell therapies.
Unfortunately, without a bright line separating legal from illegal uses of, and claims for, stem cells, the FTC and the FDA have had to play catch up in catching the bad guys (also here and here). Judging from the plethora of clinics, no one is particularly afraid of getting caught, although the FTC’s settlement might kill the amniotic “stem cell” treatment industry. In the meantime, efforts to combat unproven stem cell treatments in the academic and private sector include the International Society for Cellular Therapy Task Force on the Use of Unproven and/or Unethical Cell and Gene Therapies and the Foundation for Accreditation of Cellular Therapies program, which establishes “evidence-based requirements set by international teams of world-renowned experts vested in the improvement and progress of cellular therapy.” (Accredited organizations can be found here.)
More robust regulatory action (both rule/guidance promulgation and enforcement actions), as well as increased media coverage and private/academic efforts will eventually weed out at least some of the bad actors. In the meantime, desperate patients will continue to shell out thousands of dollars for dubious stem cell therapies.