Senate committee backs expanding settings for investigational adult stem-cell treatment with safeguards
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Summary
Sen. Beverly Powell laid out House Bill 5 147 to broaden locations where investigational adult stem-cell therapies may be given, require GMP manufacturing and expanded institutional review oversight; patients and physicians urged expanded access with medical and IRB safeguards.
House Bill 5 147 would expand settings where investigational adult stem-cell treatments may be provided in Texas, require that cell products meet FDA good manufacturing practices (GMP), and increase oversight by allowing institutional review boards to supervise treatments, Sen. Beverly Powell told the committee.
The bill builds on earlier Texas statutes (including the 2017 law often referred to as "Charlie’s Law") that permitted expanded access to certain autologous adult stem-cell procedures. Powell said the measure would allow care in outpatient facilities that offer level-2 anesthesia services while adding transparency requirements, including informed-consent language that treatments are not FDA-approved and reporting of serious adverse events to the Texas Medical Board.
Patient witnesses described personal benefits from travel to out-of-country clinics. Jennifer Ziegler said stem-cell treatment "has given me my life back." Physician witnesses supported expanding access with guardrails: Dr. Tejas Ozarker (board-certified in PM&R and interventional pain management) urged adding Texas Medical Board office-based anesthesia oversight for facility-level safeguards, physician presence and resuscitative equipment.
Committee discussion noted liability, informed consent and whether to extend liability protections historically associated with Right-to-Try statutes; Senator Powell said she would consider language addressing liability in a substitute or floor amendment. The committee closed testimony and left the bill pending for further work.
Ending: The hearing reflected a balance between patient advocates seeking more accessible options and clinicians urging GMP manufacturing standards, IRB oversight and clear facility safeguards if outpatient sites are authorized.
