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

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

Maryland has one of the country’s most developed state-level stem cell research support structures, anchored by the Maryland Stem Cell Research Fund (established 2005) and overseen by the Maryland Stem Cell Research Commission under Code of Maryland Regulations Title 14, Subtitle 04, Chapter 14.04.08. The Commission operates within the Maryland Technology Development Corporation (TEDCO). Maryland is geographically anchored to the National Institutes of Health in Bethesda and the FDA in White Oak, giving the state unusual proximity to federal regulatory and research infrastructure. Maryland adopted a Right to Try law in the mid-2010s. The Maryland Board of Physicians regulates physicians; there is no Maryland-specific commercial stem cell statute beyond the research-oriented framework.

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.

The Maryland Stem Cell Research Fund and Commission

The Maryland Stem Cell Research Fund was established by House Bill 1183 of 2005 (HB 1183 (2005)) to support stem cell research in the state. The Fund is administered by the Maryland Stem Cell Research Commission, which sits within the Maryland Technology Development Corporation (TEDCO). The Commission’s regulations are codified at COMAR Title 14, Subtitle 04, Chapter 14.04.08.

The Fund supports a broad portfolio of basic, translational, and clinical stem cell research at Maryland institutions including Johns Hopkins University, the University of Maryland, the Hugo W. Moser Research Institute at Kennedy Krieger, and others. Background on the program’s history and design: The Maryland Stem Cell Research Fund — PMC.

The Commission’s framework focuses on research; it does not directly govern commercial clinical stem cell therapy in Maryland.

The Maryland Board of Physicians

The Maryland Board of Physicians, within the Maryland Department of Health, licenses and regulates allopathic and osteopathic physicians, physician assistants, and several allied practitioner categories. The Board operates under the Maryland Medical Practice Act.

As of late 2025 [VERIFY current Board publications], the Board has not issued a comprehensive standalone policy on commercial stem cell, PRP, NAD+, or peptide therapy. Standard practice-of-medicine rules apply. The Board’s licensure verification and disciplinary action portals are at mbp.state.md.us.

Maryland’s Right to Try Law

Maryland enacted Right to Try legislation in the mid-2010s [VERIFY exact act number, session, and Maryland Code citation]. The Maryland 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 Maryland 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.

Maryland’s Federal-Adjacent Research Infrastructure

Maryland’s regenerative medicine research footprint is shaped by proximity to two major federal anchors:

  • National Institutes of Health (NIH) — Bethesda. The NIH Clinical Center, National Heart Lung and Blood Institute, National Cancer Institute, and other Institutes run extensive stem cell and cell therapy clinical research programs. NIH-sponsored trials are typically registered at clinicaltrials.gov and frequently enroll Maryland residents.
  • U.S. Food and Drug Administration (FDA) — White Oak. The Center for Biologics Evaluation and Research, including the Office of Therapeutic Products (the successor to the Office of Tissues and Advanced Therapies), is headquartered in Maryland.

Major Maryland-based academic regenerative medicine programs include the Johns Hopkins Institute for Cell Engineering, the University of Maryland School of Medicine Center for Stem Cell Biology and Regenerative Medicine, and the Kennedy Krieger Institute.

Patients with serious conditions who live in Maryland have unusually direct access to NIH-sponsored investigational protocols and should search clinicaltrials.gov for active trials before considering cash-pay commercial options.

IV Therapy and NAD+ in Maryland

NAD+ intravenous therapy is broadly available in Maryland. Registered nurses may administer IV under physician orders, and nurse practitioners have full practice authority in Maryland. IV lounges, mobile IV services, and concierge IV providers operate in Baltimore, Bethesda, Rockville, Annapolis, 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

Maryland is a member of the Interstate Medical Licensure Compact. Maryland residents can establish telehealth relationships with out-of-state physicians licensed through the compact. Maryland’s own telehealth rules expanded substantially in 2020–2021 and continue to evolve.

Notable Enforcement

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

Maryland has not been a notable focus of state attorney general action against the commercial regenerative medicine sector. Maryland’s proximity to the FDA may have a deterrent effect on aggressive commercial stem cell marketing in the state.

Cost and Clinic Landscape

Regenerative medicine clinics in Maryland cluster in the Baltimore-Washington corridor (Baltimore, Bethesda, Rockville, Frederick, Columbia, Annapolis). Celmedica currently lists [X] verified clinics across Maryland — pull live count.

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

  • PRP joint injection: $550 – $1,600 per session
  • Autologous stem cell injection (single joint or area): $5,000 – $10,500
  • NAD+ IV (single drip): $450 – $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.

NIH-sponsored clinical trial participation is realistic and often substantially cheaper or free for eligible patients, and worth investigating before pursuing cash-pay options.

Frequently Asked Questions

Is stem cell therapy legal in Maryland? Maryland has no statute prohibiting or specifically authorizing commercial stem cell therapy. Practitioners operate under federal FDA rules and Maryland Board of Physicians practice standards. Maryland’s distinctive framework is research-supportive: the state operates the Maryland Stem Cell Research Fund and Commission.

What is the Maryland Stem Cell Research Commission? The Commission is a state body that oversees the Maryland Stem Cell Research Fund, established in 2005 by HB 1183. The Commission sits within the Maryland Technology Development Corporation (TEDCO) and supports basic, translational, and clinical stem cell research at Maryland institutions.

Can Maryland residents access NIH stem cell clinical trials? Yes. Maryland residents have unusually direct access to NIH-sponsored investigational protocols at the NIH Clinical Center in Bethesda. Trials are registered at clinicaltrials.gov and many actively enroll Maryland residents.

How much does stem cell therapy cost in Maryland? Autologous stem cell injections for a single joint typically range $5,000–$10,500 in Maryland metros. PRP runs $550–$1,600. NIH and academic-medical-center clinical-trial participation is sometimes available and meaningfully cheaper or free.

Has Maryland disciplined any stem cell clinics? No major FDA warning letters against Maryland-based stem cell clinics appear in the public database as of last review. The Maryland Board of Physicians licensure verification tool is the authoritative source for individual physician disciplinary history.

Bottom Line

Maryland combines a well-developed research-support framework (Stem Cell Research Fund and Commission), proximity to federal regulatory and research infrastructure (NIH and FDA), and a moderate commercial clinic sector. For consumer-facing stem cell therapy, the federal framework dominates; Maryland adds its own Right to Try statute and Board of Physicians practice rules. Patients should focus on physician credentials, FDA product classification of the specific therapy, and — given Maryland’s federal-adjacency — whether NIH or academic-medical-center clinical trials are available before considering cash-pay options.

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 Maryland Board of Physicians, TEDCO, and the FDA, and consult a qualified physician before pursuing any therapy.

References

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

Maryland-specific: