Tennessee legislation · 114th General Assembly
Tennessee HB2246: AN ACT to amend Tennessee Code Annotated, Title 63 and Title 68, relative to stem cell therapies.
Status: Chaptered, May 26, 2026
Fiscal Summary NOT SIGNIFICANT Bill Summary This bill authorizes a doctor to perform stem cell therapy that is not approved by the United States food and drug Administration ("FDA") if the therapy is used for treatment or a procedure within the doctor's scope of practice and is related to orthopedics, wound care, or pain management. As used in this bill "stem cell therapy" means a treatment involving the use of afterbirth placental perinatal stem cells or human cells, tissues, or cellular or tissue-based products, which complies with the regulatory requirements provided in this section, but it explicitly excludes human cells or tissues that were derived from a fetus or an embryo after an abortion. STANDARDS In order to ensure the highest standard for the retrieval, manufacture, storage, and use of stem cells, this bill requires that such cells be (i) retrieved, manufactured, and stored in a facility registered and regulated by the FDA; (ii) retrieved, manufactured, and stored in a facility certified or accredited by the National Marrow Donor Program, the World Marrow Donor Association, the Association for the Advancement of Blood and Biotherapies, or the American Association of Tissue Banks; and (iii) verified to contain viable or live cells using a post-thaw analysis report, which must be sent to the doctor prior to use. FACILITY CERTIFICATION OR ACCREDITATION This bill prohibits a doctor from obtaining stem cells for therapy from a facility unless the facility maintains valid certification or accreditation. Any contract for obtaining such cells requires the facility to provide the doctor with its name, address, accrediting organization, dates of the accreditation, and any contracted limitations. The facility must also notify the doctor within 30 days of any change in accreditation status. When performing a procedure, the doct
What the bill says
From the amended text:
Senate Health and Welfare 1 Amendment No. 1 to SB2586 Crowe Signature of Sponsor AMEND S e n ate Bill No. 2586 House Bill No. 2246* by deleting all language after the enacting clause and substituting: SECTION 1. Tennessee Code Annotated, Title 63, Chapter 6, Part 2, is amended by adding the following as a new section: (a) As used in this section: (1) "Human cells, tissues, or cellular or tissue-based products": (A) Means articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient; and (B) Does not (ii) Ancillary products used in the manufacture of human cells, tissues, or cellular or tissue-based products; (iii) Cells, tissues, media, serums, and organs derived from an animal; (iv) In vitro diagnostic products; and (v) Blood vessels recovered with an organ that is intended for use in organ transplantation and are clearly labeled "For use in organ transplantation only"; (2) "Physician" means a person licensed pursuant to chapter 6 or 9 of this title; (3) "Regenerative medicine therapy": SA0975 (A) Means the use of products that: (i) Are supplied by a manufacturer that validates its isolation techniques by including cell viability and surface marker reports for cellular products, a viscosity report for Wharton's jelly, and particle counts for exosome-based regenerative products; …