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3 Best Stem Cell Therapy Clinics in Flower Mound, Texas

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Flower Mound, TX

Stem Cell Therapy clinics in Flower Mound

Stem cell and cell-based therapy in Flower Mound is a closely watched regulatory space. FDA-approved stem cell products (hematopoietic, select cord blood) are delivered at academic centers tied to Texas Health Presbyterian Flower Mound. The vast majority of cash-pay stem cell offerings, mesenchymal, adipose-derived, amniotic, exosomes, are not FDA approved. Demand reflects an affluent north Dallas suburban family base.

The FDA has aggressively pursued clinics marketing unapproved stem cell products for orthopedic, neurologic, and autoimmune indications. Clinics in Flower Mound, Texas operating in this space should be evaluated carefully for informed consent, product sourcing, and honest evidence framing. Texas rules on infusion delegation and medspa physician medical director requirements shapes enforcement posture.

With stem cell clinics on Regenerated.com in Flower Mound, patients can compare product type, FDA status, clinician credentials, and whether the clinic is enrolling in registered trials or operating outside them.

3 Clinics

MD on staff

Liberty Regenerative Therapeutics

Flower Mound, TX

Liberty Regenerative Therapeutics, a regenerative medicine clinic in Flower Mound, specializes in stem-cell therapy and platelet-rich plasma injections for chronic pain conditions. The practice appli…

  • PRP Therapy
  • Arthritis Treatment
  • Stem Cell Therapy

Health Resource Center

Flower Mound, TX

Health Resource Center, a regenerative medicine clinic in Fort Worth, offers stem-cell therapy, ozone therapy, and IV nutrient protocols alongside hormone replacement therapy. The practice takes an i…

  • Vitamin IV Therapy
  • Biofeedback Therapy
  • Ozone Therapy
  • IV Therapy
  • Oxygen Therapy
 MD on staff

Liberty Pain Associates

Flower Mound, TX

Liberty Pain Associates, a pain-management clinic in Flower Mound, Texas, offers regenerative-medicine approaches alongside conventional interventional options for chronic musculoskeletal pain. The p…

  • Arthritis Treatment
  • Stem Cell Therapy
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Regulatory context

A note on Texas's stem cell therapy rules.

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.

Sources: fda.gov · statutes.capitol.texas.gov · tmb.state.tx.us

Stem Cell Therapy in Flower Mound, answered.

Most stem cell therapies at private Flower Mound 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 Flower Mound 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. Flower Mound clinic offerings span both categories, so ask which classification applies before treatment.

Yes. Research programs at Texas Health Flower Mound and Medical City Lewisville periodically run FDA-authorized stem cell trials across orthopedics, neurology, cardiology, and oncology. Search clinicaltrials.gov and filter by Flower Mound 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.

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