Dr. Alexander GolBerg - Concierge and Aesthetic Medicine
- Stem Cell Therapy
- NAD IV Therapy
- Vitamin IV Therapy
- PRP Therapy
- IV Therapy
New York, NY
Stem Cell Therapy clinics in New York
New York is one of the densest regenerative medicine markets in the country, anchored by academic powerhouses like Weill Cornell, NYU Langone, Mount Sinai, and Columbia alongside a deep bench of private orthopedic and longevity practices across Manhattan's Upper East Side, Midtown, and Flatiron. Demand here splits across three buckets: orthopedic injections for Wall Street professionals and weekend athletes, neurological and autoimmune protocols marketed to longevity-focused patients, and IV-based allogeneic products offered in private wellness clinics. New York State regulates stem cell practice primarily through the Department of Health and the Office of Professional Medical Conduct, which has investigated multiple clinics for unapproved cell products over the past decade. 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 active Investigational New Drug authorization. New York clinics operate under that same federal framework, with academic trial programs running concurrent FDA-authorized studies. Expect a wide quality range from hospital-affiliated research programs to private single-physician practices.
Holistic Dentists
- PRP Therapy
- Ozone Therapy
- Hormone Replacement Therapy (HRT)
- TMJ Treatment
- Stem Cell Therapy
Michael Aziz, and Associates
- PRP Therapy
- IV Therapy
- Arthritis Treatment
- Peptide Therapy
- Hormone Replacement Therapy (HRT)
Dr Majid Ali Preventive Medicine
- Hormone Replacement Therapy (HRT)
- Testosterone Replacement Therapy (TRT)
- Stem Cell Therapy
Natural Wellness 360 + Aesthetics
- Vitamin IV Therapy
- PRP Therapy
- Ozone Therapy
- IV Therapy
- Ketamine Therapy
Regenerative Sportscare Institute
- PRP Therapy
- Shockwave Therapy
- Arthritis Treatment
- Stem Cell Therapy
MD on staff
NY Stem Cell Therapy & Regenerative Medicine
- PRP Therapy
- Arthritis Treatment
- Stem Cell Therapy
Dr. Jonathann Kuo, MD
- PRP Therapy
- Ozone Therapy
- IV Therapy
- Arthritis Treatment
- Peptide Therapy
Regulatory context
A note on New York's stem cell therapy rules.
New York 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 New York for orthopedic, neurologic, and longevity indications are Section 351 biologics that lack FDA approval. New York also operates a parallel state-level tissue regulation framework through the Department of Health.
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New York Education Law Title 8, Article 131 (Practice of Medicine)
Establishes physician licensure through the State Education Department Office of the Professions and discipline through the Office of Professional Medical Conduct. -
New York Public Health Law Article 43-B and 10 NYCRR Part 52
Requires tissue banks and providers handling HCT/Ps to be licensed by the New York State Department of Health, layering state oversight on top of FDA registration. -
New York General Business Law Section 349
Empowers the Attorney General and private plaintiffs to pursue deceptive marketing claims against providers making unsupported clinical claims.
The FDA has issued warning letters to New York clinics offering stem cell and exosome therapies. The New York State Department of Health enforces additional tissue bank licensing requirements under 10 NYCRR Part 52, which means clinics handling HCT/Ps face dual federal and state inspection regimes. The Office of Professional Medical Conduct has disciplined physicians for unprofessional conduct including misleading regenerative medicine advertising. The New York Attorney General has used General Business Law Sections 349 and 350 to pursue stem cell clinics making unsupported clinical claims.