Senate Bill 2586 amends Tennessee law regarding stem cell therapies by establishing a new section in the Tennessee Code Annotated. The bill defines key terms related to stem cell therapy, including "human cells, tissues, or cellular or tissue-based products," "minimally manipulated," and "stem cell therapy." It allows physicians to perform stem cell therapies that are not FDA-approved, provided they are within the physician's scope of practice and pertain to orthopedics, wound care, or pain management. The bill mandates that stem cells used in these therapies must be retrieved, manufactured, and stored in FDA-registered facilities and must meet specific viability standards.
Additionally, the bill requires physicians to provide clear notices in advertisements about the unapproved nature of the therapies and to obtain signed consent from patients before treatment. It outlines the information that must be included in the consent form, such as the nature of the treatment and potential risks. The bill also specifies that violations may lead to disciplinary action against physicians and establishes penalties for certain actions, including the use of fetal or embryonic cells in treatments. The provisions of the bill will take effect upon becoming law for rule promulgation, while other aspects will take effect on July 1, 2026.