Key findings
- Wyoming lawmakers introduced the “Stem Cell Freedom Act.”
- The bill would allow physicians to provide certain non-FDA-approved autologous stem cell therapies if specific oversight and consent requirements are met.
- It would also restrict the Wyoming State Board of Medicine from disciplining physicians solely for recommending or performing covered stem cell therapies.
The Cowboy State is hoping to follow Utah, Texas, and, most recently, Florida by introducing a bill to allow stem cell therapies before FDA approval.
Senate File 48, titled the “Stem Cell Freedom Act,” if passed, will authorize physicians to recommend and perform defined stem cell therapies as long as the conditions are met.
What “stem cell therapy” means in this bill
“Stem cell therapy” is defined as treatment involving autologous mesenchymal stem cells (MSCs, collected from the patient), including “the collection, processing, cultural expansion, manufacturing, storage, and therapeutic use of stem cells.”
The key phrase is “cultural expansion”, meaning they’ll allow labs/physicians to harvest patients’ MSCs, expand them (multiply their counts) in a lab, and then administer them. This is a shot across the bow of the FDA because in 2012, Regenexx was expanding autologous MSCs, the FDA took them to court, and won. This set a major precedent: expanding MSCs is more than “minimal manipulation” and thus requires FDA approval. This bill will give companies the green light to expand MSCs state-wide. Much like marijuana though, still not federally legal, so there could be friction.
It’s also different from Florida’s stem cell law, which centered on allogeneic (donor-derived) perinatal, unexpanded MSCs, mostly for orthopedic/pain indications. This Wyoming bill does not cover allogeneic therapies, nor does it seem to specify the indication.
Conditions
- IRB or investigational status: The therapy is conducted “in accordance with a current institutional review board” (IRB) approval, or it qualifies as an “investigational drug, biological product or device.” The bill defines an investigational product as a product that has successfully completed Phase 1 of a clinical trial but is not FDA-approved and remains under investigation.
- Manufacturing standards: The stem cells are “manufactured and handled” in line with cGMP standards.
- Physician-patient relationship: A physician-patient relationship exists.
- Written informed consent: The patient (or legally recognized representative) signs written informed consent acknowledging:
- the nature and character of the proposed stem cell therapy
- that the therapy is not FDA-approved
- potential benefits, risks, and complications, and the procedure to be performed
- the patient’s financial responsibility for paying for the therapy
The bill also specifies that the therapy must be administered by a physician or under the direct supervision of a physician (so likely no nurse practitioners, chiropractors, etc. some states do consider naturopaths physicians so this may apply).
Insurance coverage allowed?
The bill says a “health carrier” may cover costs associated with stem cell therapy, but “shall not be required” to do so. I’m unsure how this would work, as most insurance policies explicitly state they will not cover unapproved experimental stem cell therapies.
Limits on medical board discipline and state interference
The bill would prohibit the Wyoming State Board of Medicine from taking action against a physician’s license, provided they follow the conditions and consistent medical care standards.
It also states that an official, employee, or agent of the state (or any political subdivision) “shall not prohibit or attempt to prohibit a patient’s access to stem cell therapy”.
Proposed effective date
July 1, 2026.
*Not legal or medical advice*
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