The western American state of Utah has passed legislation that will allow patients to receive therapies derived from manipulated placental stem cells without the need for approval by the United States’ federal agency, the Food and Drug Administration (FDA).
The bill easily passed both houses of the Utah State Legislature in February and was signed into state law by Utah’s Governor, Spencer Cox, in March. It determines that Utah healthcare providers: “…may perform a placental stem cell therapy that is not approved by the FDA…” so long as the provider prominently notes that it is unapproved federally, and obtains a signed patient informed-consent form.
Enacted from 1 May 2024, the law permits healthcare providers and many others, defined on a long list that includes doctors, but also naturopaths, midwives and audiologists, to provide therapies that use placental stem cells.
Placental stem cells have shown experimental, clinical, promise in the test tube, and in animal studies. However no therapy has undergone a randomised human trial which would be needed for the FDA to approve its market entry.
All stem cell treatments are subject to FDA regulation unless the cells have been ‘minimally manipulated’ after their extraction from the donor, and are intended to serve the same function in the recipient that they normally have in the body.
However, in Utah the law will allow for providers to use placental stem cells that have been manipulated, and to inject them in any part of the body, and for any purpose.
The FDA can challenge Utah’s law by first sending a warning letter to any clinic administering a federally unapproved therapy. It could also escalate the issue further by seeking a court injunction to prevent a clinic from distributing placental stem cell products.
“The bill appears to blow by safeguards established by the FDA to protect patients and research participants” by allowing them to receive products lacking “convincing—or possibly any—evidence of safety and efficacy,” said Leigh Turner, a bioethicist at the University of California, Irvine.
States including Mississippi and North Carolina have passed stem cell intervention (SCI) medical freedom laws which allow unproven and experimental SCI for people with chronic disease, or severe and terminal illnesses, to be treated by a physician.
Further reading:
Utah State Legislature: Placental Tissue Amendments
The American stem cell sell in 2021: US businesses selling unlicensed and unproven stem cell interventions
