California companies lacked scientific evidence that their “amniotic stem cell therapy” could treat or cure macular degeneration and other serious diseases.
A California-based physician and the two companies he controls have settled charges of deceptively advertising that “amniotic stem cell therapy” can treat serious diseases, including Parkinson’s disease, autism, macular degeneration, cerebral palsy, multiple sclerosis, and heart attacks. The defendants even claimed that the therapy could restore the vision of blind patients, citing the case of a “101 year old Lady once blind for 7 years” who, thanks to stem cell therapy, could see again. According to the Federal Trade Commission report, Dr. Bryn Jarald Henderson, D.O. 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, with patients encouraged to undergo multiple treatments. Follow-up “booster” treatments cost between $5,000 and $8,000 each. The settlement prohibits the defendants from making these and other health claims in the future unless the claims are true and supported by competent and reliable scientific evidence. The settlement also imposes a partially suspended $3.31 million judgment and requires the defendants to notify current and former patients about the order within 30 days.
This action should serve as a warning to other companies who are making unsubstantiated claims about stem cell “cures”. At this time, no stem cell treatments for retinal diseases have been approved for clinical use by the US Food and Drug Administration (FDA). Anyone considering participation in a clinical trial should ask if the FDA has reviewed the treatment. An honest health care provider would be able to confirm this information by providing a New Drug Application (NDA) number and the chance to review the FDA communication approving its experimental use. Ask for this information before getting treatment—even if the stem cells are your own.
Joseph L. Fontenot MD, CLVT
Medical Director, Community Services for Vision Rehabilitation
600 Bel Air Blvd, Suite 110 Mobile Alabama