The US Food and Drugs Administration (FDA) is seeking permanent injunctions to stop two stem cell clinics in California and Florida from marketing stem cell products without FDA approval after reports of patients being made blind.
The FDA wants to prevent the clinics from marketing their stem cell products until they obtain necessary FDA approvals and correct their violations of current good manufacturing practice requirements, among other conditions. Both clinics failed to take action after the FDA issued warning letters in 2017.
The clinics in question are US Stem Cell Clinic in Sunrise, Florida and California Stem Cell Treatment Center, which has locations in Rancho Mirage and Beverly Hills, California.
The complaints for permanent injunction against the clinics were filed by the US Department of Justice on behalf of the FDA in the US District Court for the Southern District of Florida and the District Court for the Central District of California.
An FDA inspection of the US Stem Cell Clinic found that the clinic was processing body fat into stromal vascular fraction─a cellular product derived from body fat─and administering the product into the spinal cord of patients to treat a variety of serious conditions, including Parkinson’s disease, amyotrophic lateral sclerosis and heart disease. This treatment has not been approved by the FDA.
The FDA seized smallpox vaccine doses from California Stem Cell Treatment Center after the vaccine was used to create an unapproved and potentially dangerous stem cell product. The agency said that the treatment could cause inflammation and swelling of the heart and surrounding tissues.
Both clinics failed to follow procedures to prevent microbiological contamination of products, putting patients at risk of infection.
According to the New York Times, three patients lost their sight after the material extracted from fat by the US Stem Cell Clinic was injected directly into their eyes in 2015 to treat macular degeneration.
FDA Commissioner Scott Gottlieb said: “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. In some instances, patients have suffered serious and permanent harm after receiving these unapproved products. In the two cases filed today, the clinics and their leadership teams 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.”
In a statement, the FDA pledged to crack down on stem cell treatments that have not been proven safe or effective for use or are produced under inadequate manufacturing conditions. The agency issued four guidance documents in November 2017 on the regulation of cell-based regenerative medicine.