Stem Cell and Regenerative Medicine in Virginia: What’s Legal and What to Know

Last reviewed: 5/26 · Verify current state guidance before relying on any specific claim

Virginia is one of the few states with a state-specific consumer protection law governing the marketing and administration of FDA-unapproved stem cell treatments. Virginia law requires healthcare practitioners offering FDA-unapproved stem cell therapies to provide patients with standardized written notice, obtain documented informed consent, and disclose in advertising that the treatments are not FDA approved. The state also operates the Christopher Reeve Stem Cell Research Fund under Virginia Code § 32.1-162.31. Virginia adopted a Right to Try law in the mid-2010s. The Virginia Board of Medicine regulates physicians.

For the federal framework that applies in every state — FDA regulation of cell and tissue products under 21 CFR Part 1271, the 361/351 distinction, FDA enforcement history, and the federal Right to Try Act — see How Regenerative Medicine Is Regulated in the United States.

Virginia’s Stem Cell Disclosure and Informed Consent Law

Virginia is among a small number of states that have enacted explicit consumer protection requirements specifically for FDA-unapproved stem cell treatments. State law requires healthcare practitioners administering such treatments to:

  • Provide patients with a standardized written notice stating that the treatment is not FDA approved.
  • Obtain documented informed consent before administering the treatment.
  • Disclose in any advertisement for the treatment that it is not FDA approved.

[VERIFY exact statute citation in Title 54.1 of the Virginia Code — verify text and any 2023–2025 amendments before publishing.]

The Virginia approach is unusual: rather than restricting the availability of stem cell therapies or expanding access via a stem cell-specific medical freedom statute, Virginia imposes transparency obligations on clinics. This places Virginia in a middle position between the more permissive states that have passed stem cell medical freedom laws and the few states with active board guidance restricting unapproved cell therapy.

The Virginia Board of Medicine

The Virginia Board of Medicine, within the Virginia Department of Health Professions, licenses and regulates allopathic and osteopathic physicians, physician assistants, and several allied practitioner categories. The Board operates under Title 54.1 of the Virginia Code and 18 VAC 85.

The Board’s licensure verification and complaint portal is at dhp.virginia.gov. The Board has not issued a comprehensive standalone policy statement on commercial stem cell, PRP, NAD+, or peptide therapy beyond the statutory disclosure requirements described above [VERIFY against current Board publications].

Virginia’s Right to Try Law

Virginia enacted Right to Try legislation in the mid-2010s [VERIFY exact act number, session, and Virginia Code citation]. The Virginia law operates in parallel with the federal Right to Try Act of 2018 and allows eligible patients with terminal illnesses to access investigational drugs, biological products, and devices that have completed FDA Phase 1 clinical trials.

The Virginia statute does not authorize clinics to offer unapproved stem cell, exosome, or peptide therapies outside the narrow conditions of the Act — terminal diagnosis, exhausted FDA-approved options, physician recommendation, access through the actual sponsor of an investigational product.

The Christopher Reeve Stem Cell Research Fund

Virginia established the Christopher Reeve Stem Cell Research Fund under Virginia Code § 32.1-162.31, named for the actor and stem cell research advocate. The fund supports stem cell research in the Commonwealth and is administered in accordance with state law.

The fund is one of several state-level mechanisms across the country supporting regenerative medicine research; California’s Proposition 71 California Institute for Regenerative Medicine is the largest, but Virginia, Maryland, and several other states maintain comparable smaller-scale programs.

Virginia’s Regenerative Medicine Research Activity

Virginia hosts active regenerative medicine research at several institutions:

  • Virginia Commonwealth University Massey Cancer Center — hematologic cell therapy and bone marrow transplant programs.
  • Inova Schar Cancer Institute (Fairfax) — affiliated clinical research.
  • University of Virginia School of Medicine — basic and translational regenerative medicine research.
  • Virginia Tech Carilion Research Institute — translational biomedical research with regenerative medicine components.

Patients in Virginia with an interest in legitimate experimental access should search clinicaltrials.gov for active trials at these institutions before considering cash-pay options at commercial clinics.

IV Therapy and NAD+ in Virginia

NAD+ intravenous therapy is broadly available in Virginia. Registered nurses may administer IV under physician orders, and nurse practitioners have substantially expanded practice authority in Virginia (subject to specific transition-to-practice rules). IV lounges, mobile IV services, and concierge IV providers operate in Northern Virginia, Richmond, Hampton Roads, and other metros.

NAD+ itself is compounded through 503A or 503B pharmacies and is not FDA-approved for any indication. Patients pay out of pocket.

Telemedicine and Out-of-State Providers

Virginia is a member of the Interstate Medical Licensure Compact. Virginia residents can establish telehealth relationships with out-of-state physicians licensed through the compact. Virginia’s own telehealth rules are codified in Title 54.1 of the Virginia Code and have evolved substantially since 2020.

Notable Enforcement

The FDA’s public Warning Letter database is the authoritative source for federal enforcement against specific Virginia-based clinics [VERIFY against current list]. The 2021 federal injunction in United States v. US Stem Cell Clinic, LLC applies in Virginia as in every state.

The state-level enforcement angle in Virginia is the disclosure-and-informed-consent statute described above. Clinics offering FDA-unapproved stem cell therapies in Virginia without complying with the standardized notice, informed consent, and advertising disclosure requirements are exposed to Board of Medicine and Office of the Attorney General action [VERIFY specific enforcement record].

Cost and Clinic Landscape

Regenerative medicine clinics in Virginia cluster in Northern Virginia (Fairfax, Arlington, Alexandria), Richmond, Virginia Beach/Hampton Roads, and Charlottesville. Celmedica currently lists [X] verified clinics across Virginia — pull live count.

Typical out-of-pocket pricing in Virginia (representative ranges; individual clinics vary):

  • PRP joint injection: $500 – $1,500 per session (Northern Virginia trends higher)
  • Autologous stem cell injection (single joint or area): $5,000 – $10,000
  • NAD+ IV (single drip): $400 – $900
  • Peptide protocols: $200 – $1,200 per month, varies by compound

Insurance generally does not cover regenerative therapies. Some orthopedic indications for PRP are occasionally covered.

Frequently Asked Questions

Is stem cell therapy legal in Virginia? Virginia does not prohibit FDA-unapproved stem cell therapy, but it does require practitioners to provide standardized written notice, obtain documented informed consent, and disclose in advertising that the treatment is not FDA approved. Practitioners operate under federal FDA rules and Virginia Board of Medicine practice standards.

What disclosures do Virginia stem cell clinics have to make? Healthcare practitioners offering FDA-unapproved stem cell treatments must give patients a standardized written notice, obtain documented informed consent, and disclose in any advertising for the treatment that it is not FDA approved. Verify the specific statutory language in the current Virginia Code before relying on the exact terms.

Does Virginia’s Right to Try law cover stem cell therapy? Only in the narrow case of investigational stem cell products that have completed FDA Phase 1 trials, for a patient with a terminal illness, accessed through the actual product sponsor. The law does not authorize a clinic to offer unapproved stem cell therapy as a routine cash-pay service.

Can I get NAD+ IV therapy in Virginia? Yes. NAD+ IV is broadly available through clinics, IV lounges, and mobile services. The therapy is compounded and not FDA-approved for any indication; pricing is out of pocket.

How much does stem cell therapy cost in Virginia? Autologous stem cell injections for a single joint typically range $5,000–$10,000 in Virginia metros, with Northern Virginia clinics often pricing at the higher end. PRP runs $500–$1,500. Clinical-trial access at VCU, UVA, or Inova is sometimes available and meaningfully cheaper or free.

Bottom Line

Virginia is distinctive for its consumer-protection approach to stem cell therapy regulation — disclosure obligations and informed consent requirements rather than direct restriction or expansion. The Commonwealth supports legitimate research through the Christopher Reeve Stem Cell Research Fund and several active academic medical centers. For commercial clinical practice, patients should focus on whether the clinic complies with the state’s disclosure and informed consent requirements, physician credentials, and FDA product classification of the specific therapy.

Next steps:

[FTC affiliate disclosure block]: Some links in this guide may earn Celmedica a commission at no additional cost to you. Read our affiliate disclosure.

[Medical disclaimer]: This guide is for informational purposes and does not constitute legal or medical advice. State laws and regulatory guidance change. Verify current rules with the Virginia Board of Medicine, the Virginia Department of Health Professions, and the FDA, and consult a qualified physician before pursuing any therapy.

References

For the federal regulatory citations, see the federal baseline references.

Virginia-specific: