TX HB5147

Requires investigational stem cell treatments to use only adult stem cells that satisfy current good manufacturing practices adopted by the FDA, adding this as a new definitional requirement

Expands approved treatment locations to include outpatient settings registered to provide level II anesthesia services, in addition to existing options of licensed hospitals, ambulatory surgical centers, and medical schools

Mandates that informed consent forms must now explicitly notify patients that the treatment has not been approved for general use by the FDA

Adds a new institutional review board qualification option: registration with the U.S. Department of Health and Human Services Office for Human Research Protections under 21 C.F.R. Part 56

Modifies annual reporting requirements so institutional review boards must report on serious adverse events related to treatments, while removing the requirement that reports be made publicly available in written and electronic form

Effective date: September 1, 2025