Federal officials have filed complaints against 2 clinics in a bid to halt their unregulated adipose-derived "stem cell" treatments.
The agency filed 1 injunction against U.S. Stem Cell Clinic, LLC, a Florida-based operation responsible for a 2015 incident that blinded 3 elderly women who sought treatment for dry AMD.
“I am hopeful the increased oversight and regulation of these ‘stem cell’ clinics will help prevent other instances of harm to patients from these and similar clinics in the future,” said Ajay E. Kuriyan, MD, a retina specialist and assistant professor at the Flaum Eye Institute in Rochester, NY.
Dr. Kuriyan treated one of the women involved in the 2015 scandal. She presented with pain, elevated IOP and significant vision loss about 1 week after receiving a slurry of cells extracted from abdominal fat tissue. Despite removing the injected material in her vitreous cavity and improving her intraocular pressure, she eventually lost light perception in both eyes.
The adipose-derived stromal cells were marketed without FDA approval, according to the agency’s press release. U.S. Stem Cell Clinic was also charged with violating current good manufacturing practice requirements, including some that could “impact the sterility of their products, putting patients at risk.” The FDA filed a second injunction against California Stem Cell Treatment Center Inc. for similar violations.
In response to the FDA filings, Kristin Comella, PhD, chief scientific officer at U.S. Stem Cell Clinic, issued this statement on her Facebook page: “It is my life’s work to pioneer regenerative medicine and educate the public about its healing potential. I remain steadfast that no government agency should deprive individuals of their right to harness the cells that exist in their body.”
FDA Commissioner Scott Gottlieb, MD, acknowledged that cell-based regenerative medicine holds significant medical opportunity, but said the agency plans to continue to taking action against clinics that abuse the trust of patients.
“In the two cases filed today, the clinics and their leadership have continued to disregard the law and more importantly, patient safety,” said Dr. Gottlieb. “We cannot allow unproven products that exploit the hope of patients and their loved ones.”