The US Food and Drug Administration won a major legal victory in its ongoing effort to crack down on clinics marketing bogus and potentially hazardous stem cell products.
On Monday, a federal judge in Miami granted the FDA an injunction to prevent the Florida-based US Stem Cell Clinic from offering treatments designed to create stem cells from body fat and administering them intravenously or directly into the spinal cords of patients to treat Parkinson’s disease, amyotrophic lateral sclerosis, chronic obstructive pulmonary disease and other serious conditions.
Over the last four years, FDA investigators documented evidence that the clinic failed to establish and follow appropriate procedures to prevent microbiological contamination of products which it said put patients at risk for infections. US Stem Cell Clinic also refused to allow FDA investigators entry, except by appointment, and denied access to employees, the agency alleged.
Refusing to permit entry for an FDA inspection is a violation of federal law.
US Stem Cell Clinic maintained it was not required to comply with FDA regulations, claiming the procedure did not fall under the agency’s Food, Drug, and Cosmetic Act.