FDA regulations
Are Stem Cells FDA Approved?
Yes, stem cells can be legally administered in the U.S. as long as they meet the FDA’s criteria for being classified under Section 361 of the Public Health Service Act (PHS Act). Section 361 establishes regulations that allow for the use of certain human cells and tissues, including stem cells, without requiring full FDA approval for each individual treatment, as long as specific conditions are met. These conditions are primarily laid out under the FDA’s guidance for human cell and tissue-based products (HCT/Ps).
The 4 key criteria that stem cell therapies must adhere to in order to be classified as “361” products and be legally administered are as follows:
- Minimal Manipulation: The stem cells must be minimally manipulated. This means they should remain in the same form as when they were initially taken from the donor, with minimal processing. For example, stem cells must not undergo extensive culture, genetic modification, or other alterations beyond what’s necessary to ensure their safe and effective use.
- Homologous Use: The stem cells must be intended for a medical purpose that is similar (homologous) to the function they naturally serve in the donor’s body. For example, stem cells derived from bone marrow should be used to treat conditions related to bone marrow or blood cells, not to treat unrelated conditions like neurological disorders.
- No Combination with Other Products: The stem cells must not be combined with other drugs, devices, or biologics. If they are combined with other products (e.g., if a stem cell product is combined with a biologic or pharmaceutical agent), it may fall under the more stringent FDA requirements for drugs and biologics, which would require approval before use.
- Minimal Risk of Contamination and Safety: The stem cell therapy must meet rigorous standards for safety, including screening for infectious diseases and other contaminants. If the cells are being used in a clinical setting, they must also comply with safety protocols to minimize patient risk.
If stem cells and their applications meet all of these criteria, they can be legally administered as part of clinical treatments without needing full FDA approval as a drug or biologic. However, it is important to note that many stem cell-based therapies offered by clinics may not comply with these guidelines and could be considered illegal, especially if they involve unapproved methods or treatments that go beyond the criteria for 361 regulation.
As with any emerging treatment, patients should be cautious and consult healthcare professionals to ensure that the stem cell therapy is both legal and safe.