Important Patient and Consumer Information About Regenerative Medicine Therapies
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 firstname.lastname@example.org. 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 email@example.com.
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.
FDA has repeatedly notified manufacturers, clinics, and health care practitioners of the need for Investigational New Drug applications (INDs) to legally administer these products and to ensure safety measures are in place prior to administration.
These regenerative medicine products have risks but are often illegally marketed by clinics as being safe and effective for the treatment of a wide range of diseases or conditions, even though they haven’t been adequately studied under an IND to demonstrate the claims of safety and effectiveness. Safety concerns with any product that is illegally marketed as a regenerative medicine therapy include the following:
- Tumor formation
- Neurological events;
- Bacterial infections including life-threatening blood infections;
- Reactions at the site of collection and administration;
- Unwanted inflammatory or immune response to the cell or therapy;
- Cells moving to another part of the body and turning into an unintended type of tissue or excessively growing in the body (i.e., forming a tumor);
- Failure of the therapy to work as anticipated when approved treatments are available;
- Cross-contamination with bacteria, viruses or mold related to processing (preparation of the product) or the therapy not being tested for infectious diseases such as hepatitis and HIV.
Warnings and Safety Notifications
- FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk
- Public Safety Notification on Exosome Products
- Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes
- FDA Warns About Stem Cell Therapies
FDA letter to clinics and health care providers offering “stem cell” or related products to treat a variety of diseases or conditions
Questions and Answers Regarding the End of the Compliance and Enforcement Policy for Certain Human Cells, Tissues, or Cellular or Tissue-based Products (HCT/Ps)
1Currently, the only stem cell products that are FDA-approved for use in the United States consist of blood-forming stem cells (also known as hematopoietic progenitor cells) that are derived from umbilical cord blood. These products are approved for use in patients with disorders that affect the production of blood (i.e., the “hematopoietic” system) but they are not approved for other uses.