SB 2586

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 orthoped ics, 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 regulato ry 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, manuf actured, 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) verif ie d 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, addre ss, 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 doctor must use products from facil it ies adhering to current good manufacturing practices pursuant to the federal Food, Drug, and Cosmetic Act. NOTICE IN ADVERTISEMENT This bill requires a doctor using stem cell therapy to include a notice in any form of advertisement stating that the doctor performs therapies not yet approved by the FDA. The notice must encourage consultation with a primary care provider, be clearly legible, and be in a type size no smaller than the largest type size used in the advertisement. CONSENT This bill requires a doctor to obtain a signed consent form from the patient or the patient's representative. The form must contain (i) the nature of the proposed treatment; (ii) a statement that the therapy has not been approved by the FDA; (iii) the a nticipated results of the treatment; and (iv) the recognized risks, complications, anticipated benefits, and possible alternative treatments, including nontreatment. EXEMPTIONS This bill does not apply to doctors who have obtained FDA approval for an investigational new drug or device for the use of human cells or tissues. It also does not apply to a doctor performing therapy under a contract for institutions accredited by the Foundation for the Accreditation of Cellular Therapy, the Blood and Marrow Transplant Clinical Trials Network, the Association for the Advancement of Blood and Biotherapies, or an entity determined by the department to have expertise in stem cell therapy. VIOLATIONS This bill provides that a violation may subject the doctor to disciplinary action by the doctor's respective board. Additionally, a doctor commits a Class E felony if the doctor intentionally performs or participates in (i) treatments using human cells o r tissues derived from a fetus or embryo after an abortion; or (ii) the sale, manufacture, or distribution of computer products created using human cells, tissues, or cellular or tissue-based products. A Class E felony offense is punishable by a term of im prisonment of no less than one year nor more than six years and a potential fine not to exceed $3, 000. RULEMAKING This bill authorizes the board of medical examiners and the board of osteopathic examination to promulgate rules to effectuate this bill. ON APRIL 13, 2026, THE HOUSE ADOPTED AMENDMENT #1 AND PASSED HOUSE BILL 2246, AS AMENDED. AMENDMENT #1 rewrites the bill to, instead, authorize a physician to perform stem cell therapy or regenerative medicine therapy that is not approved by the United States food and drug administration (FDA) if such therapy is used for a treatment or proced ure that is within the scope of practice of the physician. However, a physician who performs stem cell therapy or regenerative medicine must obtain human cells, tissues, or cellular or tissue-based products for the therapy only from a facility that compl ie s with this amendment. As used in this amendment, ""human cells, tissues, or cellular or tissue-based products"" means articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer in to a human recipient. The term does not include (i) vascularized human organs for transplantation; (ii) ancillary products used in the manufacture of human cells, tissues, or cellular or tissue-based products; (iii) cells, tissues, media, serums, and org an s 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 as such. As used in this amendment, ""regenerative medicine therapy"" means the use of products that are not derived from a fetus or an embryo after an abortion, and that meet all of the following criteria: • Products that 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. • Products that contain a lot-specific sterility report and certificate of analysis for each product before the product is used on a patient. • Products that are supplied by a manufacturer that retrieves, manufactures, and stores the product in a facility that is registered with the United States food and drug administration or accredited or certified by a recognized third-party accrediting org anization including the (i) American Association of Tissue Banks; (ii) American Academy of Stem Cell Medicine; (iii) Association for the Advancement of Blood and Biotherapies; (iv) Foundation for the Accreditation of Cellular Therapy; and (v) World Marrow D onor Program. As used in this amendment, ""stem cell therapy"" means a treatment involving the use of cellular or tissue-based products that meet all of the following criteria: • Products that are retrieved, manufactured, and stored in a facility that provides the physician proof of registration from the FDA for allogeneic therapy or are retrieved, manufactured, and stored in a facility with a Clinical Laboratory Improvement Ame ndments of 1988 (CLIA) certificate of compliance for autologous therapy. • Products that are stored in a freezer that maintains a temperature no higher than negative 80 degrees Celsius, unless the products are for autologous therapy. • Products that contain viable or live cells more than 90%, as indicated in a pre-thaw certificate of analysis report, and contain at least 80% viable or live cells, as indicated in a post-thaw viability analysis report for the product lot sent before use on the patient, unless the products are for autologous therapy. • Products that contain documentation that the cellular or tissue-based products meet acceptance criteria established by validated manufacturing procedures, if used for allogeneic therapy, and consistent with applicable regulatory standards before cell ad ministration, unless the cellular or tissue-based products are used for same-day autologous therapy. However, this amendment clarifies that stem cell therapy does not include (i) treatment or research using human cells or tissues that were derived from a fetus or an embryo after an abortion; (ii) whole blood, blood components, or blood derivative produc ts; or (iii) secreted or extracted human products. ADVERTISING REQUIREMENTS This amendment requires a physician who conducts stem cell therapy or regenerative medicine therapy to include a specific notice in clearly legible font in a size no smaller than the largest type size used in each advertisement for therapy. The notice m ust state ""THIS NOTICE MUST BE PROVIDED TO YOU UNDER TENNESSEE LAW. This physician performs one (1) or more stem cell or regenerative medicine therapies that have not yet been approved by the United States food and drug administration. You are encourage d to consult with your primary care provider before undergoing any stem cell or regenerative medicine therapy."" INFORMED CONSENT This amendment requires a physician to obtain a written consent form signed by the patient or the patient's representative. APPLICABILITY This amendment does not apply to any of the following: • A physician who performs therapy approved for an investigational new drug or device by the FDA for the use of human cells, tissues, or cellular tissue-based products. • A hospital, affiliated hospital, or outpatient clinic. • A therapy performed pursuant to the Phil Timp-Amanda Wilcox Right to Try Act, which authorizes a manufacturer of an investigational drug, biological product, or device to make available such drug, product, or device to eligible patients. ADVERSE EVENTS This amendment requires that a physician who performs allogenic stem cell therapy or regenerative medicine therapy pursuant to this amendment to report an adverse event associated with such therapy to the manufacturer and to an accrediting organization w ithin 30 days. Further, a physician that performs stem cell therapy or regenerative medicine must report an adverse event associated with such therapy to the physician's licensing authority. A physician who performs stem cell therapy or regenerative med ic ine is encouraged to participate in clinical outcomes registries maintained by an accredited organization for purposes of ongoing, safety monitoring, quality improvement, and evidence-based practice development. As used in this amendment, ""adverse event"" means any untoward medical occurrence associated with the use of stem cell therapy or regenerative medicine therapy, regardless of whether such event is considered related to the therapy, including infection, allergic reaction, disease transmission, or a n unanticipated clinical outcome. RULEMAKING This amendment authorizes the boards of medical examiners and osteopathic examination to promulgate rules to effectuate this amendment."