The FDA issued a warning letter to the Sunrise, Fla.-based US Stem Cell Clinic for inaccurate marketing of its stem cell products as well as other deviations, according to the FDA.
The FDA also sent the warning letter to the clinic's Chief Scientific Officer Kristin Comella.
Here are five key points:
1. The clinic is marketing its stem cell products sans FDA approval.
2. A FDA investigation revealed US Stem Clinic processed adipose tissue into stromal fraction. The clinic's providers then injected this into patients' spinal cords, either intravenously or directly. These patients suffered from a variety of diseases, such as chronic obstructive pulmonary disease and Parkinson's disease. The FDA, however, has not approved any US Stem Cell Clinic biologic products.
3. Additionally, the US Stem Cell Clinic has strayed significantly from "current good manufacturing practice requirements." During its investigation, the FDA determined manufacturing deviations in at least 256 stem cell product lots. The FDA found some of these deviations could result in poor sterilization, such as the clinic not adhering to written procedures intended to prevent microbiological contamination of products.
4. US Stem Cell Clinic did not work cooperatively with the FDA, blocking FDA investigators from speaking to employees.
5. The clinic must deliver a response to the FDA within 15 working days, outlining how it will rectify the deviations.
"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," commented FDA Commissioner Scott Gottlieb, MD.