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

 

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

Pennsylvania has no statute or regulation specific to stem cell therapy. Practitioners offering regenerative medicine in the Commonwealth operate under the federal FDA framework — which governs the products themselves — and under the Pennsylvania State Board of Medicine, which governs the physicians who provide them. Pennsylvania adopted a Right to Try law in 2017, but did not pass stem cell-specific medical freedom legislation when it was attempted in 2018. The state is moderately active in regenerative medicine research, particularly through the University of Pennsylvania and the Children’s Hospital of Philadelphia.

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 Pennsylvania State Board of Medicine

The State Board of Medicine, operating within the Pennsylvania Department of State, licenses and regulates allopathic physicians in the Commonwealth. The Board’s authority and procedural rules are codified at 49 Pa. Code Chapter 16. Osteopathic physicians are regulated by the separate State Board of Osteopathic Medicine.

The Board has not issued comprehensive guidance specific to stem cell, PRP, NAD+, or peptide therapy as of late 2025 [VERIFY current Board publications]. Standard practice-of-medicine rules apply: physicians must practice within the scope of their license and may face discipline for offering treatments outside the standard of care or making unsupported claims to patients.

Board complaints and licensure verification: Pennsylvania Department of State professional licensing.

Pennsylvania’s Right to Try Law

Pennsylvania’s Right to Try Act is Act 33 of 2017, signed June 22, 2017 (Act No. 33 of 2017). The Act authorizes manufacturers to provide, and eligible terminally ill patients to receive, investigational drugs, biological products, and medical devices that have completed FDA Phase 1 clinical trials but have not yet received full approval.

The Pennsylvania law operates in parallel with the federal Right to Try Act of 2018. For most patients the federal framework is the operative one; the state statute is still on the books and provides additional procedural detail.

Important: Pennsylvania’s Right to Try statute does not authorize clinics to offer unapproved stem cell, exosome, or peptide therapies outside the narrow conditions of the Act. The Act requires a terminal diagnosis, exhaustion of FDA-approved options, a physician recommendation, and access through the actual drug sponsor — not a third-party clinic.

In 2018, House Bill 2633 would have created a Pennsylvania-specific “stem cell investigational medical freedom” pathway broader than Right to Try. The bill died in committee and has not been reintroduced.

Stem Cell Research Activity

Pennsylvania hosts significant regenerative medicine research infrastructure. The University of Pennsylvania’s Institute for Regenerative Medicine and the Children’s Hospital of Philadelphia’s Center for Cellular and Molecular Therapeutics conduct active clinical research on cell-based therapies. The University of Pittsburgh’s McGowan Institute for Regenerative Medicine is one of the longest-operating regenerative medicine research centers in the country.

Patients in Pennsylvania interested in legitimate experimental access should ask whether the clinic is participating in a registered clinical trial (searchable at clinicaltrials.gov) rather than a cash-pay offering of unapproved cells.

IV Therapy and NAD+ in Pennsylvania

NAD+ intravenous therapy is broadly available in Pennsylvania through clinics, IV therapy lounges, and mobile IV services. Pennsylvania allows registered nurses to administer IV therapy under physician standing orders, and certified registered nurse practitioners may prescribe and supervise IV therapy within their scope of practice (Pennsylvania Department of Health regulations).

NAD+ itself is compounded through 503A or 503B pharmacies and is not an FDA-approved drug for any indication. Patients pay out of pocket; pricing varies materially by metro and clinic.

Telemedicine and Out-of-State Providers

Pennsylvania is a member of the Interstate Medical Licensure Compact (IMLC), enabling streamlined licensure for physicians practicing across state lines. Pennsylvania residents can establish telehealth relationships with out-of-state physicians licensed through the compact, which is relevant for patients evaluating clinics in other states before traveling for treatment.

Notable Enforcement

As of the most recent review of the FDA Warning Letter database, no major FDA enforcement actions against Pennsylvania-based stem cell clinics have been publicly listed [VERIFY against current database]. Pennsylvania has not been a notable focus of state attorney general action against regenerative medicine providers.

The 2021 federal injunction in United States v. US Stem Cell Clinic, LLC applies in Pennsylvania (and every state), since the FDA’s authority is federal.

Cost and Clinic Landscape

Regenerative medicine clinics in Pennsylvania cluster in the Philadelphia, Pittsburgh, Allentown, and Harrisburg metros. Celmedica currently lists [X] verified clinics across Pennsylvania — pull live count.

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

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

Insurance generally does not cover regenerative therapies. Some orthopedic indications for PRP are occasionally covered; most patients pay out of pocket.

Frequently Asked Questions

Is stem cell therapy legal in Pennsylvania? Pennsylvania has no statute prohibiting or specifically authorizing stem cell therapy. Practitioners operate under federal FDA rules and Pennsylvania State Board of Medicine practice standards. Whether a specific therapy is legal turns on whether the product falls under FDA Section 361 (broadly permitted) or Section 351 (requires FDA approval the clinic almost never has).

Does Pennsylvania’s Right to Try law allow 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.

How much does stem cell therapy cost in Philadelphia or Pittsburgh? Autologous stem cell injections for a single joint typically range $5,000–$10,000 in Pennsylvania metros. PRP runs $500–$1,500. Pricing is set by individual clinics and is not regulated.

Can I get NAD+ IV therapy in Pennsylvania? 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.

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

Bottom Line

Pennsylvania is neither a notably permissive nor restrictive state for regenerative medicine. The Commonwealth defers almost entirely to the federal framework. Patients should focus on two questions: whether the specific therapy falls under FDA Section 361 or 351, and the credentials and disciplinary history of the physician administering it.

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 Pennsylvania State Board of Medicine and the FDA, and consult a qualified physician before pursuing any therapy.

References

For the federal regulatory citations (21 CFR Part 1271, FDA enforcement decisions, federal Right to Try Act), see the federal baseline references.

Pennsylvania-specific: