FDA looks to shut down unapproved stem cell clinics

May 11, 2018

The U.S. FDA is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval, citing significant deviations from current good manufacturing practice requirements.

A permanent injunction is being sought against U.S. Stem Cell Clinic in Sunrise, Florida, for marketing to patients stem cell products without FDA approval and while violating current good manufacturing practice requirements, including some that could impact the sterility of their products.

Additionally, the FDA is also seeking a permanent injunction to stop California Stem Cell Treatment Center, with locations in Rancho Mirage and Beverly Hills, and Cell Surgical Network Corporation of Rancho Mirage, California from marketing to patients stem cell products without FDA approval. Cell Surgical Network Corporation has a chain of about 100 stem cell clinics.

“Cell-based regenerative medicine holds significant medical opportunity, but we’ve also seen some bad actors leverage the scientific promise of this field to peddle unapproved treatments that put patients’ health at risk,” said FDA Commissioner Scott Gottlieb, M.D.

The lawsuits could have far-reaching consequences for hundreds of stem cell clinics that have opened around the country in recent years. U.S. Stem Cell Clinic fired back, saying it "believes that the patient and physician have the right to decide whether or not to use a patient’s own cells for a therapeutic purpose without federal government interference."