PRF, Exosomes, Stem Cells and related products

Platelet-Rich Fibrin (PRF), exosomes, amniotic or placental products, Wharton’s jelly preparations, and most commercially marketed stem cell products are all derived from human tissues or fluids, but none of these products are FDA-approved for therapeutic use in orthopedics, pain management, aesthetics, or wellness. PRF is an autologous blood product processed in-office, and exosomes are extracellular vesicles involved in cell-to-cell communication; however, the FDA has not approved either for any medical indication. Similarly, amniotic, placental, cord blood, and Wharton’s jelly–based materials have no FDA-approved uses for healing, regeneration, or anti-aging, despite frequent marketing claims. The FDA has repeatedly clarified that these products are considered unapproved drugs/biologics when marketed for therapeutic purposes. The only exception within this category is the use of a patient’s own cells—such as same-day autologous bone marrow aspirate—when they are minimally manipulated and used for a homologous purpose, which is allowed under the FDA’s “same surgical procedure” exemption but is not considered an FDA-approved therapy. We provide this information to ensure transparency and to help patients understand the current regulatory landscape surrounding regenerative products.