Relating to investigational stem cell treatment.
What changed between versions
Added definition requiring investigational stem cell treatment to use only adult stem cells that satisfy current good manufacturing practices adopted by the FDA.
Added requirement that treatments be administered directly by a physician certified under the relevant subsection.
Modified institutional review board requirements to include affiliation with medical schools or hospitals with at least 150 beds, accreditation by the Association for the Accreditation of Human Research Protection Programs, or registration with the U.S. Department of Health and Human Services.
Modified reporting requirements for institutional review boards to include submission of annual reports on serious adverse events to the Texas Medical Board.
Modified location requirements to specify treatments must occur at hospitals licensed under Chapter 241, ambulatory surgical centers licensed under Chapter 243, medical schools, or outpatient settings listed by a physician registered under Section 162.104.