This is a highly dubious decision for a treatment with no established record safety or efficacy, and likely contributed to the tragic outcomes of these patients.
The future of the commercial stem cell industry in the USA may rest on the result of a court battle between the FDA and U.S. Stem Cell has attracted particular scrutiny by the FDA, but has defied their regulatory authority, resulting in a legal standoff. The activities of this clinic came to my attention because a group of patients with macular degeneration suffered tragic outcomes as a result of treatment they received. In this article I will focus on one particular for-profit stem cell clinic operated by U.S. The clinics in the USA operate in a somewhat gray area of regulation by the Food and Drug Administration (FDA). There are hundreds of clinics across the USA (and the rest of the world) offering stem cell treatment of dubious merit.