“Please be careful about therapies that are not licensed and the motives of those selling them to you.”
Taylor-Weiner & Zivin. Medicine’s Wild West — Unlicensed Stem-Cell Clinics in the United States. N Engl J Med 2015; 373:985-987.
….. Although stem-cell therapy may hold great potential, the field is less advanced than the public has been led to believe. Stem-cell clinics in the United States and abroad have capitalized on this confusion by selling treatments that are not approved by the Food and Drug Administration (FDA), supported by clinical studies, or covered by insurers…..
….. The FDA has approved few treatments involving stem cells. The approved therapies use hematopoietic stem cells to treat diseases of the blood and immune system….
……. In recent years, the FDA has issued warning letters and audited some stem-cell clinics to enforce the rules for stem-cell treatments …….
……. The FDA can address the proliferation of clinics selling unapproved treatments by first establishing clear guidelines defining what procedures physicians may not perform in the absence of regulatory oversight. Then the agency may need to change its procedures for identifying and penalizing clinics that are out of compliance……
…… The FDA might increase its enforcement capabilities by coordinating with state medical boards, which have authority to revoke the licenses of physicians performing these procedures. By sharing the results of its investigations, the FDA could make it easier for these boards to penalize doctors who are defrauding patients. The added risk of an audit by a medical board might even be enough to discourage many physicians from offering unapproved procedures in the first place……
…… The Federal Trade Commission (FTC) may also be able to help reduce the misinformation in stem-cell-clinic advertising. Although clinic websites say the therapies are not FDA-approved and not proven to be effective, they suggest the procedures are based in scientific research and that there’s hope for curative outcomes…..