AN ACT to amend Tennessee Code Annotated, Title 63 and Title 68, relative to stem cell therapies.
HB2246 creates a new Tennessee framework governing stem cell therapy and regenerative medicine therapy performed by physicians. The bill defines the types of human cells, tissues, and cellular or tissue-based products covered, and it sets detailed conditions for when such therapies may be offered, including requirements tied to FDA-registered or accredited facilities, product documentation, sterility and viability testing, storage standards, and informed consent. It also excludes certain products and treatments from the definitions, including therapies involving fetal or embryonic tissue after abortion, whole blood and blood derivatives, and certain secreted or extracted human products.
The bill allows a physician to perform an otherwise unapproved stem cell or regenerative medicine therapy if it is within the physician’s scope of practice and the physician obtains products only from compliant facilities. It requires advertising disclosures warning patients that the therapy has not yet been approved by the FDA and advising consultation with a primary care provider. It also requires written patient consent, mandates adverse-event reporting, encourages participation in clinical outcomes registries, and authorizes the Board of Medical Examiners and the Board of Osteopathic Examination to adopt rules. The act takes effect immediately for rulemaking and on July 1, 2026 for all other purposes.
HB2246 amends Tennessee Code Annotated Titles 63 and 68 by establishing state-level standards for the practice, sourcing, advertising, consent, and reporting requirements associated with stem cell and regenerative medicine therapies. It creates compliance obligations for physicians and manufacturers/facilities involved in these therapies, and it exposes physicians who violate the section to possible disciplinary action by their licensing authority. The bill also carves out exceptions for FDA investigational new drug/device therapies, hospitals and affiliated outpatient clinics, and therapies under Tennessee’s Right to Try law.
The bill appears to have been broadly supported and moved through the process with unanimous committee and floor votes, including 7-0, 19-0, 10-0, 91-0, and 31-0 votes. That voting pattern suggests a generally favorable sentiment toward creating guardrails for stem cell and regenerative medicine practices while still allowing physicians to offer certain therapies. The lack of recorded opposition in the available history indicates little formal resistance during consideration.
No major contention is reflected in the available committee or floor vote history, as every recorded vote was unanimous. The bill’s most likely areas of policy sensitivity are the balance between patient access and consumer protection, the allowance of non-FDA-approved therapies within a physician’s scope of practice, and the detailed restrictions on sourcing and product standards. The exclusions for fetal or embryonic tissue-derived treatments and the disciplinary enforcement provisions may also be notable points of concern for some stakeholders, but no specific objections are documented in the provided materials.