Bill > HB5147

This bill modifies Texas law regarding investigational stem cell treatments by updating several key provisions. The bill clarifies 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 current good manufacturing practices, in addition to being under investigation in a clinical trial and not yet approved for general use. The bill also requires that informed consent forms now explicitly note that the treatment has not been FDA-approved and that the department administers this regulatory subchapter. Additionally, the legislation expands the locations where investigational stem cell treatments can be administered to include outpatient settings with specific physician registration, and broadens the criteria for institutional review boards overseeing these treatments. The bill also modifies reporting requirements, mandating that institutional review boards submit annual reports to the Texas Medical Board about serious adverse events, while removing the previous requirement to make these reports publicly available. The changes aim to provide more clarity and oversight for investigational stem cell treatments, with the new provisions set to take effect on September 1, 2025.

Health and Social Services

https://capitol.texas.gov/BillLookup/History.aspx?LegSess=89R&Bill=HB5147