Stem Cell Therapy (Direct-to-Consumer)

Stem cells are cells in the body that can make copies of themselves (self-renew). They can also develop (differentiate) into more specialized cells. The body naturally uses stem cells to replace damaged and diseased tissue. There is interest in using stem cell therapy as a medicine.

The US Food and Drug Administration (FDA) has approved stem cell therapy for limited use in some people with cancer or aplastic anemia. Stem cell therapy is also being studied in some clinical trials under an "Investigational New Drug" or "IND" application. Stem cell therapy that is FDA-approved or that is being studied under an IND application helps assure that the product is safe, pure, and of appropriate strength.

But there are companies marketing stem cell therapy directly to consumers for many unapproved conditions and without an IND application. These conditions include diabetes, heart disease, Parkinson disease, and many others. There's no good scientific evidence to support these uses. Direct-to-consumer stem cell therapy is also unsafe and has been linked to many serious adverse events including death.