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

Last reviewed: 4/26· Verify current state guidance before relying on any specific claim

Wisconsin has a paradoxical place in American regenerative medicine: it is the state where the first human embryonic stem cell lines were derived — by Dr. James Thomson at the University of Wisconsin–Madison in 1998 — and home to the WiCell Research Institute and the Morgridge Institute for Research. Yet Wisconsin has no statutes specifically addressing stem cell research or clinical practice beyond its Right to Try law. The Wisconsin Right to Try Act, 2017 Wisconsin Act 165, is also distinctive: unlike the federal Right to Try Act and the laws of most other states (which require investigational drugs to have completed FDA Phase 1), the Wisconsin statute requires the investigational product to be in a Phase 2 or Phase 3 trial, or to have completed Phase 3 and be pending FDA approval. The Wisconsin Medical Examining Board 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.

Wisconsin’s Right to Try Law

Wisconsin’s Right to Try Act is 2017 Wisconsin Act 165, signed in March 2018 (2017 Wisconsin Act 165). The Act and its accompanying drafting memorandum are available as a PDF from the Legislative Council.

Wisconsin’s RTT framework is notably stricter than most state versions in its definition of “investigational drug, biological product, or device.” Where most state RTT statutes (and the federal RTT Act) require the product to have completed FDA Phase 1, Wisconsin requires:

  • Under investigation in an FDA-approved Phase 2 or Phase 3 clinical trial, or
  • Completed a Phase 3 clinical trial and pending FDA approval or licensure.

This raises the evidentiary bar materially. A product can only qualify under Wisconsin’s Act if it has already passed Phase 1 safety testing and entered later-stage efficacy testing.

The Act also includes liability protections for physicians:

  • Physicians are immune from civil or criminal liability or professional discipline based solely on a recommendation of an experimental treatment to an eligible patient to treat the patient’s terminal illness.

Eligibility requirements:

  • Diagnosis of a life-threatening disease.
  • Exhausted FDA-approved treatment options.
  • Unable to participate in clinical trials.
  • Recommendation from a treating physician licensed by Wisconsin and in good standing.

Background commentary on the operational implications for Wisconsin patients, providers, and manufacturers: The Right to Try in Wisconsin — McCarty Law.

Wisconsin’s RTT statute, even with its higher evidentiary bar, does not authorize clinics to offer unapproved stem cell, exosome, or peptide therapies outside the narrow conditions of the Act.

Wisconsin’s Stem Cell Research History

Wisconsin’s research significance is unusual. In 1998, Dr. James Thomson at the University of Wisconsin–Madison derived the first human embryonic stem cell lines, a discovery that transformed the field of regenerative medicine globally.

Key Wisconsin institutions:

  • University of Wisconsin–Madison — Stem Cell and Regenerative Medicine Center, Waisman Center, Wisconsin Institutes for Medical Research.
  • WiCell Research Institute (Madison) — independent non-profit established in 1999 to support the original Thomson stem cell lines; now a global repository for stem cell lines.
  • Morgridge Institute for Research (Madison) — independent translational research institute affiliated with UW–Madison.
  • Medical College of Wisconsin (Milwaukee) — academic medical center with active translational research.
  • Marshfield Clinic Research Institute — translational and clinical research in central Wisconsin.

For an overview of state stem cell research law context, the Wisconsin Legislative Council maintains a useful brief: Overview of Federal Stem Cell Research Law (Wisconsin Legislative Council).

Wisconsin is one of approximately 21 states that do not have laws specifically addressing stem cell research — the state’s research environment has historically operated under federal NIH rules, university IRB processes, and Wisconsin general medical practice law rather than under stem cell-specific statutes.

The Wisconsin Medical Examining Board

The Wisconsin Medical Examining Board, within the Wisconsin Department of Safety and Professional Services, licenses and regulates allopathic and osteopathic physicians. The Board operates under Wisconsin Statutes Chapter 448 and Wisconsin Administrative Code Chapter Med.

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 and informed-consent rules apply.

IV Therapy and NAD+ in Wisconsin

NAD+ intravenous therapy is broadly available in Wisconsin. Registered nurses may administer IV under physician orders. Wisconsin’s APRN scope-of-practice framework expanded in recent years, and nurse practitioners may prescribe and supervise IV therapy within their scope.

IV lounges, mobile IV services, and concierge IV providers operate in Milwaukee, Madison, Green Bay, Appleton, 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

Wisconsin is a member of the Interstate Medical Licensure Compact. Wisconsin residents can establish telehealth relationships with out-of-state physicians licensed through the compact.

Notable Enforcement

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

Wisconsin has not been a notable focus of state attorney general action against the commercial regenerative medicine sector. The presence of UW–Madison, WiCell, the Morgridge Institute, the Medical College of Wisconsin, and Marshfield Clinic has channeled significant cell-therapy activity through legitimate academic and trial-based pathways.

Cost and Clinic Landscape

Regenerative medicine clinics in Wisconsin cluster in Milwaukee, Madison, Green Bay, Appleton, Wausau, and the Marshfield Clinic catchment area. Celmedica currently lists [X] verified clinics across Wisconsin — pull live count.

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

  • PRP joint injection: $500 – $1,300 per session
  • Autologous stem cell injection (single joint or area): $4,500 – $9,000
  • NAD+ IV (single drip): $400 – $850
  • 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.

UW–Madison, the Medical College of Wisconsin, and Marshfield Clinic Research Institute participation in clinical trials is sometimes available and meaningfully cheaper or free for eligible patients.

Frequently Asked Questions

Is stem cell therapy legal in Wisconsin? Wisconsin has no statutes specifically addressing stem cell research or clinical practice. Commercial stem cell therapy operates under federal FDA rules and Wisconsin Medical Examining Board practice standards.

How is Wisconsin’s Right to Try Act different from other states’ RTT laws? Wisconsin’s RTT Act (2017 Wisconsin Act 165) requires the investigational product to be in a Phase 2 or Phase 3 FDA-approved clinical trial, or to have completed Phase 3 and be pending FDA approval. Most other state RTT laws and the federal RTT Act allow access to products that have only completed Phase 1.

Why was Wisconsin so important to the development of stem cell research? Dr. James Thomson at the University of Wisconsin–Madison derived the first human embryonic stem cell lines in 1998 — one of the foundational discoveries of modern regenerative medicine. WiCell Research Institute was established the next year to support these lines and remains a major global repository.

Does Wisconsin’s RTT law allow stem cell clinics to offer unapproved therapies? No. Wisconsin’s RTT law, like the federal RTT Act and other state versions, requires an active investigational pathway through the product’s actual sponsor. It does not authorize routine commercial offering of unapproved stem cell therapies.

How much does stem cell therapy cost in Wisconsin? Autologous stem cell injections for a single joint typically range $4,500–$9,000 in Wisconsin metros. PRP runs $500–$1,300. Clinical-trial access at UW–Madison, the Medical College of Wisconsin, or Marshfield Clinic Research Institute is sometimes available and meaningfully cheaper or free.

Bottom Line

Wisconsin combines deep research history (the original 1998 Thomson stem cell derivation at UW–Madison) with a notably restrained statutory framework — no stem cell-specific laws, and a Right to Try Act with a higher evidentiary bar than most. For commercial stem cell therapy, the federal framework dominates; Wisconsin adds its own Medical Examining Board practice rules and a Phase 2/3 RTT pathway. Patients should focus on physician credentials, FDA product classification of the specific therapy, and whether clinical-trial access is available at UW–Madison, the Medical College of Wisconsin, or Marshfield Clinic before considering cash-pay commercial 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 Wisconsin Medical Examining Board and the FDA, and consult a qualified physician before pursuing any therapy.

References

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

Wisconsin-specific: