NASHVILLE, Tenn. – The Tennessee House of Representatives this week unanimously passed legislation by State Rep. Chris Hurt, R-Halls, creating ethical and medical guardrails for stem cell therapy in the Volunteer State.
House Bill 2246 allows physicians to provide stem cell or regenerative medicine therapies that are not approved by the U.S. Food and Drug Administration (FDA)iftreatments are within their scope of practice. All cells, tissues or cellular- or tissue-based products must be obtained from a facility registered with the FDA or an accredited third-party, and cannot be derived from an aborted unborn child.
“Stem cell therapy is a lifeline for many in our state, and this legislation protects patients while safeguarding access to innovative treatments,” said Hurt. “By establishing a clear framework, Tennessee can uphold high standards, protect public health and expand availability to safe and effective therapies. I’m grateful to my colleagues for their overwhelming support, and I look forward to seeing this proposal’s impact on the health and well-being of Tennesseans.”
Stem cell therapy uses living stem cells to repair, replace or regenerate tissues in the body to address a growing number of diseases, injuries and disorders. It can be used to treat people with leukemia, Hodgkin disease, non-Hodgkin lymphoma and other cancers, among other diseases, according to the Mayo Clinic.
Hurt’s proposal requires advertisements for non-FDA-approved stem cell therapies or regenerative medicine treatments to include a notice divulging that information and encouraging consultation with a person’s primary care provider. Written consent signed by a patient or a patient’s representative must be obtained before treatment.
Any adverse events from stem cell therapy must be reported to a physician’s licensing authority. Physicians must also report adverse events from allogeneic stem cell therapy, which utilizes donor stem cells, to the manufacturer and the accrediting organization within 30 days.
House Bill 2246 encourages physicians to participate in clinical outcomes registries, which collect data on specific diseases, devices and procedures. Registries help ensure ongoing safety monitoring and promote evidence-based practice development and quality improvement.
The companion version of the legislation will be considered by the Senate on April 15. If passed and signed by Gov. Bill Lee, it will take effect immediately for promulgating rules, and on July 1 for all other purposes.
State Rep. Chris Hurt lives in Halls and represents District 82 in the Tennessee House of Representatives, which includes Crockett, Lauderdale and part of Gibson and Obion counties.