FDA Cracks Down on Unapproved Stem-Cell Clinics

The U.S. Food and Drug Administration (FDA) filed complaints in May seeking permanent injunctions against two stem cell clinics, U.S. Stem Cell Clinic of Sunrise, Florida and the California Stem Cell Treatment Center, as part of a comprehensive approach to overseeing regenerative medicine products.

In the case of U.S. Stem Cell Clinic, the FDA is seeking a permanent injunction against the company, its chief scientific officer, and its co-owner and managing officer for marketing unapproved products for the treatment of a variety of diseases, including Parkinson’s disease, amyotrophic lateral sclerosis, chronic obstructive pulmonary disease, heart disease, and pulmonary fibrosis. The clinic also engaged in improper manufacturing practices, including some that could impact the sterility of their products. The company failed to address and correct previous violations outlined by the FDA in a warning letter sent in August 2017.

When sending that letter, the agency also learned that the California Stem Cell Treatment Center was administering a commercially smallpox vaccine to cancer patients with potentially compromised immune systems. The FDA directed the U.S. Marshals Service to seize supplies of the vaccine and is now ordering the center and its founders to cease marketing unapproved products and to correct its manufacturing violations.

“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, MD. “In [these two cases], the clinics and their leadership have continued to disregard the law and, more importantly, patient safety. We cannot allow unproven products that exploit the hope of patients and their loved ones.”

Source: FDA news release, May 9, 2018; The New York Times, May 9, 2018.