Legal action against US stem therapy claims

A US federal agency legal case has found that the defendants lacked scientific evidence to prove their ‘amniotic stem cell therapy’ could treat or cure serious diseases including Parkinson’s, macular degeneration and cerebral palsy.

The Federal Trade Commission (FTC) is a US federal agency that protects consumers by stopping unfair, deceptive or fraudulent practices in the marketplace.

It filed and has now settled a complaint against California-based physician Dr. Bryn Henderson alleging that Henderson acted as the main spokesman and marketer of two stem cell therapy companies he owns, Regenerative Medical Group and Telehealth Medical Group. The FTC said that Henderson promoted the claim, without evidence, that stem cell therapy could treat a wide range of serious diseases including Parkinson’s disease, multiple sclerosis, cerebral palsy, macular degeneration, osteoarthritis, strokes and chronic kidney disease.

Henderson and the two companies he controls have agreed a settlement, which prohibits them 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 US$3.31 million judgment and requires the defendants to notify current and former patients about the order within 30 days.

Andrew Smith of the FTC’s Bureau of Consumer Protection: “Clinics must have solid evidence to back up their claims before advertising that stem cell therapy can treat serious medical issues, particularly those affecting children and older adults.

Regenerative Medical Group and Telehealth Medical Group earned US$3.31 million offering stem cell therapy between 2014 and 2017. Initial stem cell therapy injections ranged from US$9,500 to US$15,000, with patients encouraged to undergo multiple treatments. Follow-up booster treatments cost between US$5,000 and US$8,000 each.

Advertising on its website (now taken down), the defendants 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, from stem cell therapy, could see again. The website’s homepage stated that the therapy could “reverse autism symptoms“.

The order prohibits the defendants from misrepresenting that any product or service:

  1. Cures, mitigates, or treats any disease or health condition, including Parkinson’s disease, autism, multiple sclerosis, cerebral palsy, traumatic brain injury, heart disease, macular degeneration, chronic kidney disease, osteoarthritis, and stroke.
  2. Is comparable, or better than, conventional medical treatments in treating any health condition, unless such claims are true and can be supported by competent and reliable scientific evidence. The order also imposes a US$3.31 million judgment against the defendants that will be partially suspended after they pay US$525,000 to the FTC, which may be used to provide refunds to consumers harmed by the defendants’ allegedly deceptive conduct. The order also requires the defendants to notify all current and former patients of the settlement within 30 days.

The FTC filed the complaint and order in the U.S. District Court for the Central District of California. The FTC files a complaint when it has reason to believe that the law has been or is being violated and it appears that a proceeding is in the public interest. Stipulated final injunctions/orders have the force of law when approved and signed by the District Court judge.

Medical treatment claims made for stem cells also have regulatory implications under the Federal Food, Drug, and Cosmetic Act (FDC Act). The penalties for marketing an unapproved biological product can be severe, including imprisonment, civil and criminal fines and injunctions against further activities as well as seizure of the products involved.