The U.S. Food and Drug Administration has issued a warning letter to StemGenex of San Diego after an investigation found its cellular therapy does not conform with good manufacturing practice requirements, is being illegally marketed to treat conditions for which it has not been proven safe or effective, and is putting patients at risk. The company is alleged to be more than minimally manipulating fat tissue and administering it into patients without an FDA license or approval for an investigational new drug. The warning letter claims that StemGenex illegally markets its product to treat a variety of serious diseases and life-threatening conditions including Alzheimer’s disease, spinal cord injury, multiple sclerosis, and more. ISSCR is aware of no compelling scientific evidence that cells derived from fat tissue can provide a therapeutic benefit for these diseases.
Additionally, the Federal Trade Commission (FTC) recently reached a financial settlement with California-based Regenerative Medical Group, Telehealth Medical Group, and Dr. Bryn Jarald Henderson, founder of the groups, for making deceptive and unsubstantiated claims that its stem cell therapies could treat or cure conditions such as Parkinson’s disease, autism, macular degeneration, cerebral palsy, and others. Currently there are no proven stem cell treatments for those diseases. The FTC issued a consumer-focused blog to warn potential patients about deceptive stem cell therapy claims.
“We are pleased that these federal agencies are holding unscrupulous clinics accountable for violating regulations set up to ensure the public that biomedical treatments are proven safe and effective for patient use,” said ISSCR president Douglas Melton. “The number of clinics offering stem cell interventions that have little basis in science or medicine has grown dramatically in recent years. We hope these FDA and FTC actions send a strong message to bad actors peddling unproven stem cell interventions that they cannot continue fraudulent operations that are putting patients at risk.” A number of Americans have already been blinded or paralyzed from unproven stem cell treatments.
The FDA action follows complaints filed earlier this year to halt the marketing and delivery of unproven stem cell treatments at clinics alleged to be operating outside of FDA regulation: California Stem Cell Treatment Center, Cell Surgical Network Corporation, and U.S. Stem Cell Clinic in Florida. Those clinics had similarly been offering stem cell interventions whose safety and effectiveness have not been established in clinical trials, nor gone through the FDA approval process.
The ISSCR provides information about stem cell science and its translation to medicine on A Closer Look at Stem Cells.