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Clinics in Houston, New York

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Houston, NY

Stem Cell Therapy clinics in Houston

Houston supports a regenerative medicine market shaped by both private clinics and regional academic medicine. Local referral networks run through Houston Methodist, MD Anderson, and Baylor College of Medicine, and stem cell practice in the area spans the Texas Medical Center, River Oaks, and the Galleria. 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. House Bill 810 (2017) permits licensed Texas physicians to administer investigational adult stem cell treatments for patients with severe chronic diseases or terminal illnesses under institutional review board oversight, without an FDA Investigational New Drug authorization. Texas Medical Board licensure is required, and advertising is regulated under the Texas Occupations Code. The 30 Houston clinics listed below have been reviewed against our vetting criteria, including federal NPI lookup, OIG exclusion screening, and Texas Medical Board licensure checks.

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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.

  • 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.

Sources: fda.gov · health.ny.gov · op.nysed.gov

Stem Cell Therapy in Houston, answered.

Most stem cell therapies at private Houston clinics are not FDA-approved. The FDA has approved certain hematopoietic stem cell products for blood and immune disorders, but stem cell injections for orthopedic, neurological, or longevity use are generally investigational. They require a Biologics License or an active Investigational New Drug authorization, or they must qualify as Section 361 minimally manipulated and homologous-use products under 21 CFR Part 1271. House Bill 810 (2017) permits licensed Texas physicians to administer investigational adult stem cell treatments for patients with severe chronic diseases or terminal illnesses under institutional review board oversight, without an FDA Investigational New Drug authorization.

In the Houston metro, single-joint autologous bone marrow or adipose injections typically run $4,000 to $12,000 per session. Systemic IV protocols using allogeneic umbilical cord or Wharton's jelly products range $8,000 to $20,000, and full multi-session protocols can reach $15,000 to $40,000. Exosome add-ons range $3,500 to $7,500. Insurance rarely covers these treatments because the FDA classifies most protocols as investigational.

Autologous stem cells come from your own body, usually harvested from bone marrow aspirate or adipose tissue and reinjected the same day. When minimally manipulated and used for homologous function, they often fall under FDA Section 361, which does not require pre-market approval. Allogeneic stem cells come from a donor source, most commonly umbilical cord blood or Wharton's jelly, and are generally classified as Section 351 biologics that require an active Investigational New Drug authorization. Houston clinic offerings span both categories, so ask which classification applies before treatment.

Yes. Research programs at Houston Methodist, MD Anderson, and Baylor College of Medicine periodically run FDA-authorized stem cell trials across orthopedics, neurology, cardiology, and oncology. Search clinicaltrials.gov and filter by Houston or the broader metro to see active recruiting studies. Trial participation is typically low-cost or free compared to commercial protocols and includes structured follow-up with imaging and lab monitoring.

Verify physician licensure through the Texas Medical Board and confirm the clinic's NPI number through the NPPES registry. Check the FDA warning letter database for the clinic name and the HHS Office of Inspector General exclusion list. Ask whether the treatment is Section 361 or Section 351, whether the clinic operates under an Investigational New Drug authorization for allogeneic or expanded products, and whether adverse events are tracked. Ask specifically about compliance with HB 810.

Treatment guide

Learn about Stem Cell Therapy

What it is, how it works, and what to expect.

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