Unlicensed Stem Cell Therapies Ruled Subject to FDA Regulation
A recent ruling in US District Court in US vs Regenerative Sciences declared that stem cell therapies are “drugs” and “biologics” and subject to regulation by the FDA. This ruling will help reign in the ‘wild west’ atmosphere of stem cell therapy with multiple companies over promising unproven treatments. Blue Horizon Stem Cells of New York City claims to treat heart disease, arthritis, diabetes, Alzheimer’s disease, sports injuries, spinal cord injuries, stroke and many other conditions. The Stem Cell Rejuvenation Center of Phoenix, AZ charges a flat rate for treatment of a wide variety of conditions. And the Stem Cell Institute of Fort Lauderdale, FL promises treatment for multiple sclerosis, Rheumatoid Arthritis, autism, cerebral palsy and other auto-immune diseases.
“These clinics are selling hope,” said Ole Isacson MD of Harvard Medical School and “things can only be improved by stronger regulation.” The relatively slow pace of scientifically proven stem cell therapy is understandably frustrating. But, patients deserve evident that therapies are safe, effective and worth taking the risk of treatment.
Neurology Today, January 17, 2013