Important Patient and Consumer Information About Regenerative Medicine Therapies

This FDA information page explains what regenerative medicine products are legally approved in the United States. It says the only FDA-approved stem cell products are certain blood-forming cells made from umbilical cord blood, for specific blood disorders. No stem cell products are approved to treat conditions such as arthritis, chronic pain, or neurological diseases. The FDA warns that unapproved treatments can cause infections, harmful immune reactions, tumors, or blindness, and this page is based on regulatory reviews and reported problems rather than a new patient study.

What this means for you: Be cautious about clinics selling stem cell, exosome, or other regenerative treatments without FDA approval. Do not rely on testimonials or claims that a treatment is “natural” or risk-free; ask a qualified doctor and check the FDA’s approval status first.