Arizona Pushes New Stem Cell Therapy Bill
Arizona lawmakers are advancing SB 1214, a bill that would allow certain non-FDA-approved stem cell and birth tissue therapies, with limitations.
Key findings
- An Arizona Senate committee is advancing SB 1214, the “Arizona Stem Cell Therapy Act”, which would allow physicians to offer certain non-FDA-approved stem cell and birth tissue therapies under defined sourcing, quality, and informed consent standards.
- SB 1214 includes advertising disclosure language, civil penalties, and a felony prohibition on therapies using tissue derived from aborted fetuses or embryos.
Arizona’s Senate Health and Human Services Committee has advanced SB 1214, the “Arizona Stem Cell Therapy Act.” The bill is sponsored by Senator Janae Shamp and is framed as an expansion of Arizona’s approach as a “Right to Try” state. This adds to the list of states with or pushing to enact laws to allow unproven stem cell treatments, including Florida, Wyoming, Utah, and more.
What the bill would do
SB 1214 would permit physicians to offer certain stem cell therapies and birth tissue therapies that are not FDA-approved, as long as those services are delivered within a physician’s scope of practice and meet requirements related to sourcing, transparency, informed consent, and quality control.
“When Arizona patients pursue innovative therapies, they deserve to know treatments are being delivered safely and responsibly,” stated Senator Shamp. “This legislation puts medical guardrails in place, strengthens transparency, and helps ensure bad actors cannot take advantage of vulnerable people searching for hope. We are promoting access to therapies while making sure patients know they are receiving care that meets recognized medical standards.”
Key requirements in SB 1214
The bill’s provisions include:
- Ban on aborted fetal or embryonic tissue: SB 1214 explicitly prohibits using cells or tissues derived from aborted fetuses or embryos in any stem cell or birth tissue therapy. Willful violations would be classified as a Class 5 felony and could also trigger professional discipline.
- Sourcing and facility standards: The bill would require that stem cells and birth tissues come from facilities registered with the FDA or accredited by organizations listed in the bill, including the American Association of Tissue Banks, the Association for the Advancement of Blood and Biotherapies, the National Marrow Donor Program, or the World Marrow Donor Association.
- Product documentation and manufacturing controls: SB 1214 would require post-thaw viability reports for live stem cells and certificates of analysis for birth tissues. Those certificates would need to confirm negative tests for communicable diseases and the presence of growth factors. The bill also calls for compliance with federal good manufacturing practices. This is similar to Florida’s bill.
- Informed consent: Physicians would need to disclose that treatments are not FDA-approved, describe risks, benefits, and alternatives, and encourage patients to consult with a primary care provider.
- Advertising disclosure: The bill would require a specific disclosure in “prominent type” in advertising: “This notice is required by Arizona law. This physician offers one or more stem cell therapies or birth tissue therapies that are not approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care provider before undergoing any stem cell therapy or birth tissue therapy.”
- Civil remedies: Patients harmed by violations could seek $10,000 in statutory damages per violation, plus attorney fees.
What supporters argued in testimony
Brigham Buhler, who runs a famous regenerative medicine and wellness clinic called Ways2Well (he’s been on Joe Rogan Experience a few times), testified saying: “The standard of care is to have a preplanned C-section so that you can get the most out of that tissue. So, healthy birth, healthy mother, pre-planned C-section is how they collect this discarded afterbirth tissue to avoid any cross contaminants. Those tissues, when applied appropriately into the right patient under the right standards of care, can be life changing. I’ve seen it impact soldiers who come back from war. I have seen it impact patients with Alzheimer’s, dementia. We’ve helped orthopedic injuries, knees, shoulders, elbows, soft tissue. The beauty of these products is they’re healing you from within.”
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