Important Patient and Consumer Information About …

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 persons body, include stem cells, stromal vascular fraction (fat-derived cells), umbilical cord blood and/or cord blood stem cells1, amniotic fluid, Whartons 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 FDAs 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 FDAs July 2020 Consumer Alert:

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 havent 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:

Helpful Links

FDA Voices

Warnings and Safety Notifications

FDA Warning Letters

FDA/CBER Untitled Letters

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.

07/09/2021

See original here:
Important Patient and Consumer Information About ...