Are stem cell therapies safe and legal in the USA? | Orthopedic Associates

By John Urse, DO

The U.S. Food and Drug Administration (FDA) says that adult stem cells are ‘biologic products’, and since it is a patients’ own blood, component, or therapeutic serum, it is “applicable to prevention, treatment or cure of a condition or disease in human beings.” They are also allowed for athletes who compete, as they are one’s own native tissues. Thus, stem cells and platelets do not require oversight and are not regulated by the FDA . They are of low risk as they are comprised of one’s own human blood and bone-marrow products.