June 3, 2021
The US Food and Drug Administration (FDA) regulates regenerative medicine products. There continues to be broad marketing of unapproved products considered regenerative medicine therapies that are intended for the treatment or cure of a wide range of diseases or medical conditions. These products require FDA licensure/approval to be marketed to consumers. Before approval, these products require FDA oversight in a clinical trial. These unapproved products whether recovered from your own body or another person’s body, include stem cells, stromal vascular fraction (fat-derived cells), umbilical cord blood and/or cord blood stem cells1, amniotic fluid, Wharton’s jelly, ortho-biologics, and exosomes. FDA has received reports of blindness, tumor formation, infections, and more, detailed below, due to the use of these unapproved products.
If you are being offered any of these products outside of a clinical trial for which FDA has oversight, please contact FDA at ocod@fda.hhs.gov. Additionally, contact FDA if you are considering treatment with any of these products and have questions, or if you have been treated with these products and wish to report any adverse effects or file a complaint. We take these reports seriously and want to hear from you.
If you were hurt or had a bad side effect following treatment with a regenerative medicine product, or a similar product, we also encourage you to report it to the FDA’s MedWatch Adverse Event Reporting program. Additional information for patients on reporting adverse events for these products can be found here.
Please know that if you are being charged for these products or offered these products outside of a clinical trial, you are likely being deceived and offered a product illegally. Likewise, FDA is aware that patients and consumers are being referred to clinicaltrials.gov, or are told that a product is registered with FDA, as a way to suggest that the products being offered are in compliance with FDA laws and regulations. This is often false. The inclusion of a product in the clinicaltrials.gov database or the fact that a firm has registered with FDA and listed its product does not mean the product is legally marketed. If you are considering receiving one of these products, please contact FDA at ocod@fda.hhs.gov.
This web posting reemphasizes the warning to consumers in FDA’s July 2020 Consumer Alert:
- Regenerative medicine therapies have not been approved for the treatment or prevention of COVID-19, acute respiratory distress syndrome (ARDS), or any other complication related to COVID-19.
- Regenerative medicine therapies have not been approved to treat autism, macular degeneration, blindness, chronic pain, or fatigue.
- Regenerative medicine therapies have not been approved to treat any neurological disorder, such as multiple sclerosis, amyotrophic lateral sclerosis (ALS; Lou Gehrig’s disease), Alzheimer’s disease, Parkinson’s disease, epilepsy, or stroke.
- Regenerative medicine therapies have not been approved for the treatment of any cardiovascular or pulmonary (lung) diseases, such as heart disease, emphysema, or chronic obstructive pulmonary disease (COPD).
- Regenerative medicine therapies have not been approved for the treatment of any orthopedic condition, such as osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain, or shoulder pain.