ReGen Advanced Infusion and Wellness Center
- PRP Therapy
- Ketamine Therapy
- Arthritis Treatment
- Peptide Therapy
- Hormone Replacement Therapy (HRT)
Phoenix, AZ
Phoenix supports a regenerative medicine market shaped by both private clinics and regional academic medicine. Local referral networks run through Mayo Clinic Arizona, Banner Health, and HonorHealth, and stem cell practice in the area spans Biltmore, Arcadia, and North Phoenix corridors. 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. Arizona Senate Bill 1442 (2022) requires providers offering non-FDA-approved stem cell therapies to disclose that status in writing. The Arizona Medical Board regulates physician practice, and the state has seen active FDA warning letter activity against Scottsdale and Phoenix-area stem cell operators. The 17 Phoenix clinics listed below have been reviewed against our vetting criteria, including federal NPI lookup, OIG exclusion screening, and Arizona Medical Board licensure checks.
Regulatory context
In Arizona, cellular products are governed by federal rules under 21 CFR Part 1271. Products that are minimally manipulated and used for homologous use fall under Section 361 and do not require premarket approval. Products that are more than minimally manipulated, used non-homologously, or combined with another article are regulated as biological drugs under Section 351 and require an Investigational New Drug application or Biologics License Application. Most adipose-derived stromal vascular fraction and culture-expanded stem cell procedures marketed for orthopedic, neurologic, or longevity indications are Section 351 products.
The FDA has issued warning letters and untitled letters to stem cell providers operating in Arizona for marketing unapproved biological products. Arizona is home to several high-profile regenerative clinics, and FDA inspections in the state have cited violations of current good manufacturing practice and unapproved drug claims. The Arizona Medical Board has disciplined physicians for unprofessional conduct tied to misleading advertising of stem cell outcomes. No statewide injunction parallel to the US v California Stem Cell Treatment Center case has been issued in Arizona, but enforcement exposure remains elevated.