Is stem cell therapy FDA-approved in Texas?

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.

How much does stem cell therapy cost in Houston?

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.

What's the difference between autologous and allogeneic stem cells?

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.

Are there FDA-authorized stem cell clinical trials in Houston?

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.

How do I know a stem cell clinic in Houston is legitimate?

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.

Clinics in Houston, Texas

Texas 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 Texas for orthopedic, neurologic, and longevity indications are Section 351 biologics that lack FDA approval. Texas enacted a state-level investigational adult stem cell framework in 2017 that does not override federal law.

Texas HB 810 (2017), Texas Health and Safety Code Chapter 1003
Authorizes administration of investigational adult stem cell treatments to eligible patients with severe chronic or terminal illness when conducted by Texas-licensed physicians at facilities meeting defined institutional review board oversight criteria.
Texas Medical Practice Act, Texas Occupations Code Title 3, Subtitle B
Establishes physician licensure and discipline through the Texas Medical Board.
Texas Pharmacy Act, Texas Occupations Code Chapter 551 et seq
Regulates compounding pharmacies aligned with federal 503A and 503B standards.

The FDA has issued warning letters to Texas clinics offering stem cell and exosome therapies. The Texas Medical Board has disciplined physicians for unprofessional conduct including misleading regenerative medicine advertising. The Texas Attorney General has used the Texas Deceptive Trade Practices Act to pursue providers making unsupported clinical claims. HB 810 expressly does not preempt federal law, so even Texas providers operating under HB 810 must comply with 21 CFR Part 1271 and remain subject to FDA enforcement if products fall outside Section 361.

Clinics in Houston, Texas

Every listing is checked against federal records, reviewed for evidence, and confirmed still operating. No pay-to-play. No guesswork.

Stem Cell Therapy clinics in Houston

Innova Pain Center

Skilled Pain Care Clinic

Athletic Orthopedics & Knee Center

Omega Precision Oncology

Fondren Orthopedic Group

Cendant Stem Cell Center

LifeStem Regenerative Medicine

Minimally Invasive Brain and Spine Institute

Texas Pain Rehab

Cendant Stem Cell Hair Restoration and Transplant Clinic

Principle Spine and Pain

Venus Restorative Health and Wellness Center

Men's Health Clinic

Texas Pain And Regenerative Medicine

Renew Body Wellness & Testosterone Clinic

A note on Texas's stem cell therapy rules.

Stem Cell Therapy in Houston, answered.

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