New “Placental Tissue Amendment” Bill Clarifies Disclosures Required to Perform Stem Cell Therapies in Utah

The “Placental Tissue Amendment Bill”, Part of SB 0199, Has Been Passed by the Utah State Legislature.

The “Placental Tissue Amendment Bill“, part of SB 0199, recently passed by the Utah State Legislature, introduces specific requirements for healthcare providers administering treatments involving placental stem cells. The key focus of this bill is to ensure that patients receive adequate disclosures regarding the nature of the treatment, particularly if it involves stem cell therapy that hasn’t been approved by the United States Food and Drug Administration (FDA).

Under this legislation, medical professionals who administer treatments using placental stem cells, including those involving therapies not approved by the FDA, are mandated to provide patients with certain disclosures.

Specifically, a health care provider whose scope of practice includes the use of stem cell therapy may perform a stem cell therapy that is not approved by the U.S. FDA if the health care provider provides the patient with the following written notice before performing the therapy:

‘THIS NOTICE MUST BE PROVIDED TO YOU UNDER UTAH LAW. This health care practitioner performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care provider before undergoing a stem cell therapy.'”

The medical profession also needs to get a signed consent form before performing the therapy, signed by the patient or their representative. This consent form needs to explain the:

• Nature and character of the proposed treatment, including the treatment’s U.S. FDA approval status (or lack thereof)
• Anticipated results of the proposed treatment
• Recognized possible alternative forms of treatment
• Recognized serious possible risks, complications, and anticipated benefits involved in the treatment

The goal of this disclaimer is to inform patients about the status of the treatment they are about to receive and emphasizes the importance of consulting with their primary care provider before undergoing the therapy. It aims to ensure that patients are fully aware of the nature of the treatment, any associated risks, and the fact that it has not received FDA approval.

Of course, primary physicians are not yet broadly trained in cellular medicine, so that reality may limit the efficacy of this approach.

By implementing this requirement, the bill seeks to enhance transparency and promote informed decision-making among patients considering treatments involving placental stem cells. It underscores the importance of patient autonomy and the right to make informed choices about their healthcare options. Additionally, it aligns with broader efforts to regulate the use of stem cell therapies and ensure patient safety and well-being.

The Chief Sponsor of the bill was Senator Curtis S. Bramble. Its Effective Date is May 1, 2024.

The full bill passed by Utah’s 2024 General Session, called the “PLACENTAL TISSUE AMENDMENTS” bill, can be accessed here.