House Bill 2246, also known as 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 unapproved stem cell therapies for specific medical purposes, such as orthopedics, wound care, or pain management, provided that the stem cells are retrieved, manufactured, and stored in FDA-registered facilities that meet certain accreditation standards. Additionally, physicians must ensure that the stem cells used are viable and must provide patients with clear information about the nature of the treatment, including risks and alternatives.
The bill also mandates that physicians obtain informed consent from patients before performing stem cell therapy and includes specific advertising requirements to inform potential patients that the therapies have not been FDA-approved. It outlines penalties for violations, including disciplinary action from medical boards and potential felony charges for certain prohibited practices, such as using cells derived from a fetus or embryo after an abortion. The bill empowers the board of medical examiners and the board of osteopathic examination to promulgate rules to implement these provisions. The act will take effect upon becoming law for rule-making purposes, while other provisions will take effect on July 1, 2026.