US Stem Cell Clinic LLC, of Weston, Florida, and US Stem Cell Inc., of Sunrise, Florida, and their Chief Scientific Officer Kristin Comella, Ph.D. have adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue, U.S. District Judge Ursula Ungaro of the Southern District of Florida declared in a summary judgment against the defendants.

On behalf of FDA, The U.S. Department of Justice filed for a permanent injunction against the defendants in May 2018, after several attempts to provide the clinic and the individual defendants the opportunity to work with the agency to come into compliance with FDA regulations and protect patients from harm.

FDA had raised concerns about US Stem Cell in a warning letter issued in 2017 for marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements, following an FDA inspection of the facility that found that the company was administering its product intravenously or via other methods of administration to treat a variety of serious diseases or conditions, including Parkinson’s disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease and pulmonary fibrosis. The FDA has not approved any biological products manufactured by US Stem Cell Clinic for any use.

Several patients said they were blinded or suffered significant vision loss following treatments at the facility.

The clinic was also cited for its failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile, which puts patients at risk for infections. 

In a separate action, the FDA is also seeking a permanent injunction to stop California Stem Cell Treatment Center Inc., with locations in Rancho Mirage and Beverly Hills, California; Cell Surgical Network Corporation of Rancho Mirage, California; and Elliot B. Lander, M.D. and Mark Berman, M.D., from marketing to patients cellular products without FDA approval. That litigation is ongoing. In addition, to date, the FDA has taken numerous other steps to bring clinics and other companies or individuals manufacturing stem cell products with known or potential violations into compliance by issuing warning letters, untitled letters and other letters of correspondence to firms.