US Stem Cell Clinics, Patient Safety, and the FDA

Clinics advertising adipose-derived autologous ‘stem cell treatments’ are proliferating across the USA. The rapid spread of businesses promoting unapproved stem cell interventions reveals a widening gulf between federal regulations governing stem cell based therapies and a marketplace where few companies selling such interventions are subjected to regulatory action. Fatal outcomes, complications, and lawsuits have not slowed this rush to the marketplace [1, 2, 3, 4].

Cell Surgical Network (CSN) is the most visible example of the emergence of US businesses selling unlicensed stem cell interventions. CSN is an association of over 50 clinics promoting adipose-derived ‘stem cell treatments’ for amyotrophic lateral sclerosis, Parkinson's disease, multiple sclerosis, muscular dystrophy, stroke, cardiomyopathy, and many other diseases and injuries. Another company, StemGenex, promotes access to commercial ‘stem cell therapy studies’ for Alzheimer's disease, multiple sclerosis, type I and type II diabetes, Crohn's disease, and other illnesses. Between 100 and 200 such businesses are estimated to be operating in the USA [5]. The multiplication of such clinics represents a dramatic shift in which individuals can...