Bill > SB1827

This bill modifies Texas state law regarding investigational stem cell treatments by refining several key provisions. The bill updates the definition of "investigational stem cell treatment" to specifically require that such treatments use only adult stem cells that meet the United States Food and Drug Administration's good manufacturing practices. It mandates that informed consent forms now explicitly notify patients that the treatment is not FDA-approved for general use and that the department administers the regulatory subchapter. The bill expands the locations where investigational stem cell treatments can be administered, adding outpatient settings with specific physician registration requirements to the existing list of hospitals, surgical centers, and medical schools. Additionally, the legislation modifies reporting requirements for institutional review boards overseeing these treatments, now requiring annual reports to the Texas Medical Board about serious adverse events while removing the previous requirement to make reports publicly available. The bill also adds an additional criterion for institutional review board accreditation and removes patient identifying information from these reports. These changes aim to provide more structured oversight and transparency for investigational stem cell treatments while protecting patient privacy and ensuring treatment quality, with the new regulations set to take effect on September 1, 2025.

Health and Social Services

https://capitol.texas.gov/BillLookup/History.aspx?LegSess=89R&Bill=SB1827