Tennessee expanded its Right to Try Act in 2025 with the Right to Try for Individualized Treatments Act (SB 282 / HB 192), signed by Governor Bill Lee. The law allows terminally ill patients to access personalized experimental therapies after all FDA-approved treatment options have been exhausted.
The legislation protects patients and their families from certain medical debt or insurance liability if the patient dies during treatment. It also prevents licensing boards from disciplining healthcare providers who recommend individualized therapies in good faith. The law creates a pathway for patients with rare or ultra-rare diseases to receive treatments tailored to their genetic profiles, and allows manufacturers or treatment facilities to either provide therapies at no cost or charge patients for manufacturing expenses.
✅ What’s Legal in Tennessee?
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Adult Investigational Stem Cell Treatments:
Physicians can legally offer investigational, non-FDA-approved adult stem cell therapies to patients with severe chronic or terminal illnesses, following written recommendations and informed consent. (fsmb.org) -
Standard Autologous & PRP Therapies:
Same-day, minimally manipulated procedures—such as autologous stem cells (bone marrow, adipose) and PRP—for pain relief and orthopedic purposes are legal under normal practice standards. (kellumstemcellinstitute.com) -
Clinical Trials Participation:
Patients may also access investigational treatments via FDA-approved trials or Tennessee’s expanded right-to-try provisions as part of the new law.
⚠️ What to Watch Out For
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Eligibility Criteria Are Specific:
The law applies only to severe chronic or terminal conditions, as defined by state health rules. Physicians must document patient eligibility and other treatment steps ’ -
Informed Consent Is Crucial:
SB 152 mandates written informed consent, the use of state-developed forms, and physician oversight. Licensure cannot be revoked if conditions are properly met. -
FDA & Federal Law Still Apply:
Despite state backing, Tennessee providers offering expanded or manipulated cell products may still fall under FDA jurisdiction.
Smart Steps Before You Begin
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Verify your provider’s licensure with the Tennessee Board of Medical Examiners.
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Confirm patient eligibility for investigational stem cell treatment—ask to see the signed informed consent. (Stem cell cost)
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Ask for oversight details—such as physician supervision, cell processing, and clinical documentation.
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Consult your primary doctor, especially if considering high-risk or experimental procedures.
State Regulation Resource
Visit the Tennessee General Assembly Bill Information page for SB 152 and definitions:
LegiScan – Tennessee SB 152 (2025)
⚠️ Important Disclaimer
This guide is for informational purposes only and does not constitute medical or legal advice. Patients should consult with a qualified provider before undergoing any regenerative treatment.
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