46 Stem Cell Therapy Clinics in New York City, New York

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.

• 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.