Quote from FDA Press Release on Stem Cell Clinics issued August 28, 2917:
“Stem cell clinics that mislead vulnerable patients into believing they are being given safe, effective treatments that are in full compliance with the law are dangerously exploiting consumers and putting their health at risk,” said FDA Commissioner Scott Gottlieb, M.D. “As the FDA takes new steps to advance an efficient, modern approach to the regulation of cell based regenerative medicine, at the same time we will be stepping up our enforcement actions against clinics that abuse the trust of patients and, more important, endanger their health with unsanitary conditions or by purporting to have treatments which may not provide any benefit.”
In a New York Times article also published August 28, describes the FDA crackdown on stem cell clinics. Three stem cell clinics were inspected by the FDA. Two of the facilities were California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills California. The Rancho Mirage stem cell clinic received a 11-page, 11-observation 483. The Beverly Hills stem cell clinic received a 10-page, 13-observation 483. The third facility US Stem Cell Clinic received a 7-page 12-observation 483.
Some of the observations included:
- Manufacturing process not validated.
- Aseptic processes not established or followed
- No sterility / endotoxin testing
- No environmental monitoring
- No identity testing of raw materials
- No batch or production records
- No cleaning procedures developed, followed
- No Quality Control unit
In one case stem cells were injected into the eyes of the patients. NYT article March 2017, also published in the New England Journal of Medicine [subscription required]. In summary, a 72 year old patient permanently lost sight in both eyes, and a 78 and 88 year old patient each lost much of their eyesight following treatment.
As identified by Willis Triplett PharmD, in his email blog (Aug 29) the FDA Oncologic Drug Advisory panel provided a unanimous (10-0) recommendation for Novartis Car T therapy and this new drug therapy may be approved very soon. These therapies offer a unique promise of individualized medicine. However, stem cell therapy is not a panacea for every disease. In a 2016 NEJM article the FDA share their perspective “to ensure that this emerging field fulfills its promise to patients, we must first understand its risks and benefits and develop therapeutic approaches based on sound science. Without a commitment to the principles of adequate evidence generation that have led to so much medical progress, we may never see stem-cell therapy reach its full potential.”