The Tennessee General Assembly advanced HB 413 and SB 152 during the 2025 legislative session, a pair of companion bills that would authorize patients with severe chronic diseases or terminal illnesses to access investigational stem cell treatments not yet approved by the U.S. Food and Drug Administration (FDA). The Senate Health and Welfare Committee passed SB 152 unanimously (9-0) in March 2025, signaling growing legislative interest in expanding patient access to regenerative therapies within the state. Under existing federal law, only a narrow set of stem cell products, primarily hematopoietic (blood-forming) stem cells derived from umbilical cord blood for certain blood cancers and immune disorders, carry full FDA approval. Most other stem cell therapies remain classified as investigational, and the FDA regulates them as drugs or biologics under 21 CFR Part 1271.
Regenerative medicine clinics in Tennessee offer therapies that include autologous procedures using a patient’s own bone marrow or adipose tissue, allograft treatments derived from donated umbilical cord tissue, platelet-rich plasma (PRP) injections, and intravenous nutrient infusions designed to complement cellular therapies. The FDA distinguishes between minimally manipulated human cells, tissues, and cellular and tissue-based products (HCT/Ps) intended for homologous use, which face lighter regulatory requirements, and products that undergo more than minimal manipulation or target non-homologous conditions, which require premarket approval through the investigational new drug (IND) pathway. Since December 2018, the FDA has issued more than 400 letters to manufacturers and health care providers offering potentially violative stem cell or related products, and federal appellate courts in the Ninth and Eleventh Circuits have upheld the agency’s authority to regulate these treatments as drugs.
Physicians administering stem cell therapies in Tennessee must hold an active medical license issued by the Tennessee Board of Medical Examiners (BME), which requires graduation from an accredited medical school, completion of postgraduate training, passage of the USMLE, and 40 hours of continuing medical education every two years, including two hours on controlled substances. Tennessee participates in the Interstate Medical Licensure Compact (IMLC), allowing physicians licensed through the compact to practice across member states. No separate state license exists specifically for regenerative medicine; the practice falls under the physician’s general medical license and the scope of their training and board certifications. Patients considering regenerative therapies should ask whether a specific treatment holds FDA approval or is being administered under an active IND application, request documentation of cell count and viability testing, and verify that the treating physician maintains board certification in a relevant specialty such as orthopedic surgery, physical medicine and rehabilitation, or pain management.
Tennessee’s three major metropolitan regions, Nashville, Memphis, and Knoxville, each host regenerative medicine practices serving patients with orthopedic injuries, neurological conditions, autoimmune disorders, and general wellness concerns. Prospective patients should confirm whether a clinic processes cells in an on-site laboratory or sends specimens to an external facility, as in-house processing allows tighter quality control over cell handling and storage. Reviewing a provider’s published outcome data, patient testimonials verified through third-party platforms, and any adverse event disclosures adds another layer of due diligence. The Tennessee Division of Consumer Affairs accepts complaints related to medical services, and the BME investigates allegations of unprofessional conduct, providing additional accountability channels for patients who believe a provider has made misleading claims about treatment efficacy.
Top Stem Cell Therapy Providers in Tennessee
1. Vita Nova Stem Cell Professionals
Address: 4601 Carothers Parkway, Suite 325, Franklin, TN 37067
Phone: (615) 801-8005
Website: vitanovatn.com
Services: stem cell therapy, PRP therapy, A2M therapy, IV therapy, ultrasound-guided injections
Vita Nova Stem Cell Professionals operates from Franklin and maintains an in-house laboratory where autologous cells harvested from the patient’s own body are processed and expanded under direct physician supervision rather than being sent to external facilities. Each patient who undergoes stem cell therapy receives documented cell count and viability reports detailing exactly what is administered during the procedure. Injections are delivered using real-time ultrasound guidance and fluoroscopy imaging to place cells at the targeted site. The clinic’s service menu spans four core therapies: stem cell therapy for tissue repair, platelet-rich plasma (PRP) injections for skin rejuvenation and tissue recovery, alpha-2-macroglobulin (A2M) protein therapy aimed at cartilage protection and joint inflammation reduction, and intravenous nutrient infusions delivering vitamins, minerals, and hydration. Conditions addressed include orthopedic joint injuries, neurological disorders, systemic and organ-level concerns, and general wellness optimization. Board-certified physicians with over 30 years of combined clinical experience conduct one-on-one consultations that review medical history, evaluate symptoms, examine relevant imaging, and produce individualized care plans adjusted as treatment progresses. The practice reports a 95 percent patient satisfaction rate and maintains 100 percent in-house quality control over cell processing from collection through delivery.
Frequently Asked Questions About Stem Cell Therapy in Tennessee
Q: Are stem cell therapies FDA-approved?
Only a limited number of stem cell products hold full FDA approval, specifically hematopoietic stem cell products used to treat certain blood cancers and immune system disorders. Most regenerative therapies offered at clinics for orthopedic, neurological, or wellness indications remain classified as investigational. The FDA has stated that clinics marketing unapproved stem cell products may face enforcement action, including warning letters and court injunctions.
Q: What should Tennessee patients ask before receiving stem cell therapy?
Patients should request documentation showing whether the treatment is FDA-approved or being administered under an active investigational new drug (IND) application. Asking for cell count and viability reports, reviewing the physician’s board certifications, and confirming whether the clinic maintains an on-site processing laboratory are practical steps. The Tennessee Board of Medical Examiners license verification portal allows patients to confirm a physician’s active license status and check for disciplinary history.
Q: Does insurance cover stem cell therapy in Tennessee?
Most private insurance plans and Medicare do not cover stem cell therapies for orthopedic, neurological, or wellness conditions because these treatments have not received FDA approval for those indications. Patients should expect to pay out of pocket and request a written cost breakdown before consenting to treatment. Clinics that claim insurance coverage for non-FDA-approved procedures should be approached with caution.
Q: What is the difference between autologous and allograft stem cell treatments?
Autologous treatments use cells harvested from the patient’s own body, typically from bone marrow or adipose (fat) tissue, and re-administered during the same visit or after laboratory processing. Allograft treatments use donor-derived tissue, often sourced from umbilical cord blood or Wharton’s jelly collected during live births. The FDA applies different regulatory standards depending on whether cells are minimally manipulated and used for homologous purposes or undergo expansion and target non-homologous conditions.
Q: How does Tennessee regulate physicians who offer regenerative medicine?
Tennessee does not issue a separate license for regenerative medicine practitioners. Physicians must hold an active medical license from the Tennessee Board of Medical Examiners, maintain 40 hours of continuing medical education per biennial renewal cycle, and practice within the scope of their training and board certifications. The BME investigates complaints of unprofessional conduct, and the Tennessee Division of Consumer Affairs handles broader consumer protection concerns related to medical services.