Compass Human Performance
- Ozone Therapy
- IV Therapy
- Arthritis Treatment
- Lyme Disease Treatment
- Peptide Therapy
Nashville, TN
Stem Cell Therapy clinics in Nashville
Nashville supports a regenerative medicine market shaped by both private clinics and regional academic medicine. Local referral networks run through Vanderbilt University Medical Center, Saint Thomas Health, and TriStar Centennial, and stem cell practice in the area spans Green Hills, the Gulch, and Belle Meade. Patient demand splits across three buckets: orthopedic injections for active adults and aging athletes, neurological and autoimmune protocols marketed to longevity-focused patients, and IV-based allogeneic products offered by private wellness clinics. The FDA classifies most stem cell injections for orthopedic, neurological, or longevity use as investigational biologics under 21 CFR Part 1271, meaning they require either a Biologics License or an active Investigational New Drug authorization. Autologous bone marrow and adipose products may qualify as Section 361 when minimally manipulated and used for homologous function. Tennessee passed the Regenerative Medicine Act in 2017, which recognizes adult stem cell therapies and requires informed consent and outcome reporting. Nashville and Memphis clinics operate under both state law and federal 21 CFR Part 1271 rules. The Tennessee Board of Medical Examiners oversees physician practice. The 4 Nashville clinics listed below have been reviewed against our vetting criteria, including federal NPI lookup, OIG exclusion screening, and Tennessee Board of Medical Examiners licensure checks.
61Five Health & Wellness
- Stem Cell Therapy
- NAD IV Therapy
- Vitamin IV Therapy
- PRP Therapy
- Ozone Therapy
Replenish I.V. Hydration+Wellness
- Stem Cell Therapy
- NAD IV Therapy
- Vitamin IV Therapy
- IV Hydration
- Migraine Treatment
The Pro2col
- Ozone Therapy
- IV Therapy
- IV Hydration
- Hyperbaric Oxygen Therapy (HBOT)
- Arthritis Treatment
Next Health The Gulch
- PRP Therapy
- Ozone Therapy
- IV Therapy
- Hyperbaric Oxygen Therapy (HBOT)
- Arthritis Treatment
Regulatory context
A note on Tennessee's stem cell therapy rules.
Tennessee cellular therapy is governed by 21 CFR Part 1271. Section 361 covers minimally manipulated HCT/Ps used for homologous use without premarket approval. Section 351 covers products that are more than minimally manipulated, used non-homologously, or combined with another article, and these require an IND for clinical use or a BLA for marketing. Most stem cell, stromal vascular fraction, and exosome therapies marketed in Tennessee for orthopedic, neurologic, and longevity indications are Section 351 biologics that lack FDA approval. Tennessee enacted a state-level investigational regenerative medicine framework in 2017 that does not override federal law.
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Tennessee Regenerative Medicine Act, Tennessee Code Annotated Section 63-6-244 (2017)
Authorizes Tennessee physicians to provide investigational regenerative therapies under defined conditions while disclaiming any conflict with federal law and requiring informed consent. -
Tennessee Medical Practice Act, TCA Title 63, Chapter 6
Establishes physician licensure and discipline through the Tennessee Board of Medical Examiners. -
Tennessee Pharmacy Practice Act, TCA Title 63, Chapter 10
Regulates compounding pharmacies aligned with federal 503A and 503B standards.
The FDA has issued warning letters to Tennessee clinics offering stem cell and exosome therapies. The Tennessee Board of Medical Examiners has disciplined physicians for unprofessional conduct including misleading regenerative medicine advertising. The Tennessee Attorney General has used the Tennessee Consumer Protection Act to pursue providers making unsupported clinical claims. The Tennessee Regenerative Medicine Act explicitly does not preempt federal regulation, so Tennessee providers cannot rely on the state framework as a defense to FDA enforcement.