Polaris Rejuvenation
- PRP Therapy
- Shockwave Therapy
- IV Therapy
- Peptide Therapy
- Erectile Dysfunction (ED) Treatment
Columbus, OH
Columbus supports a regenerative medicine market shaped by both private clinics and regional academic medicine. Local referral networks run through The Ohio State University Wexner Medical Center, Nationwide Children's, and Mount Carmel, and stem cell practice in the area spans the Short North, German Village, and Dublin border. 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. Ohio regulates physician practice through the State Medical Board of Ohio. There is no Ohio-specific stem cell statute, so federal 21 CFR Part 1271 rules apply. Cleveland Clinic and Ohio State anchor regional academic trial activity. The 6 Columbus clinics listed below have been reviewed against our vetting criteria, including federal NPI lookup, OIG exclusion screening, and State Medical Board of Ohio licensure checks.
Regulatory context
Ohio 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 Ohio for orthopedic, neurologic, and longevity indications are Section 351 biologics that lack FDA approval. Ohio hosts substantial academic regenerative medicine research at Case Western and Cleveland Clinic.
The FDA has issued warning letters to Ohio clinics offering stem cell and exosome therapies. The State Medical Board of Ohio has disciplined physicians for unprofessional conduct including misleading regenerative medicine advertising. The Ohio Attorney General has used the Consumer Sales Practices Act to pursue providers making unsupported clinical claims. Ohio's combination of academic IND-based research and direct-to-patient regenerative clinics produces a mixed compliance landscape.