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Clinics in Mclean, Virginia

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Mclean, VA

Stem Cell Therapy clinics in Mclean

Mclean supports a regenerative medicine market shaped by both private clinics and regional academic medicine. Local referral networks run through Inova Fairfax Hospital and MedStar Georgetown, and stem cell practice in the area spans Tysons, downtown McLean, and the Chain Bridge Road corridor. 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. Virginia regulates physician practice through the Virginia Board of Medicine. There is no Virginia-specific stem cell statute, so federal 21 CFR Part 1271 rules apply. The 3 Mclean clinics listed below have been reviewed against our vetting criteria, including federal NPI lookup, OIG exclusion screening, and Virginia Board of Medicine licensure checks.

3 Clinics

MD on staff

StemCell ARTS

Mclean, VA

StemCell ARTS, a regenerative-medicine clinic in McLean, specializes in orthobiologic and cell-based therapies for musculoskeletal conditions. The practice offers bone-marrow concentrate, platelet-ri…

  • PRP Therapy
  • Arthritis Treatment
  • TMJ Treatment
  • Stem Cell Therapy
 MD on staff

National Spine & Pain Centers

Mclean, VA

National Spine & Pain Centers, a regenerative pain-management clinic in McLean, VA, offers orthobiologic and cell-based therapies alongside conventional interventional options. The practice provides …

  • PRP Therapy
  • Laser Therapy (LLLT)
  • Arthritis Treatment
  • Stem Cell Therapy
 MD on staff

National Spine & Pain Centers

Mclean, VA

National Spine & Pain Centers, a regenerative pain-management practice in McLean, Virginia, specializes in orthobiologic and cell-based therapies for musculoskeletal and joint conditions. The clinic …

  • PRP Therapy
  • Arthritis Treatment
  • Stem Cell Therapy
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Regulatory context

A note on Virginia's stem cell therapy rules.

Virginia 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 Virginia for orthopedic, neurologic, and longevity indications are Section 351 biologics that lack FDA approval. Northern Virginia clinics often draw patients from the District of Columbia.

  • Virginia Medical Practice Act, Code of Virginia Title 54.1, Chapter 29
    Establishes physician licensure and discipline through the Virginia Board of Medicine.
  • Virginia Pharmacy Practice Act, Code of Virginia Title 54.1, Chapter 33
    Regulates compounding pharmacies aligned with federal 503A and 503B standards.
  • Virginia Consumer Protection Act, Code of Virginia Title 59.1, Chapter 17
    Empowers the Attorney General and private plaintiffs to pursue deceptive marketing claims against providers making unsupported clinical claims.

The FDA has corresponded with Virginia providers offering cellular therapies, and warning letters have been issued to regional clinics. The Virginia Board of Medicine has disciplined physicians for unprofessional conduct including misleading regenerative medicine advertising. The Virginia Attorney General has used the Virginia Consumer Protection Act to pursue providers making unsupported clinical claims. Virginia's proximity to FDA headquarters in Maryland keeps Northern Virginia clinics under close federal observation.

Sources: fda.gov · dhp.virginia.gov · oag.state.va.us

Stem Cell Therapy in Mclean, answered.

Most stem cell therapies at private Mclean 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. Virginia regulates physician practice through the Virginia Board of Medicine.

In the Mclean 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. Mclean clinic offerings span both categories, so ask which classification applies before treatment.

Yes. Research programs at Inova Fairfax Hospital and MedStar Georgetown periodically run FDA-authorized stem cell trials across orthopedics, neurology, cardiology, and oncology. Search clinicaltrials.gov and filter by Mclean 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 Virginia Board of Medicine 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 federal 21 CFR 1271.

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