BILL ANALYSIS

Senate Research Center	H.B. 5147
89R12486 MCF-F	By: King et al. (Parker)
	Health & Human Services
	5/20/2025
	Engrossed

AUTHOR'S / SPONSOR'S STATEMENT OF INTENT

Promising adult stem cell therapies offer hope for patients with a variety of diseases and conditions. Since 2017, investigational adult stem cell treatments have provided access to experimental therapies that have not yet received full approval from the U.S. Food and Drug Administration (FDA). However, current regulations are limiting, creating barriers to these treatments for patients, and additional safeguards are available that serve to promote patient safety and ethical medical practices.

H.B. 5147 grants patients greater access to investigational adult stem cell treatments by allowing them to be administered in additional healthcare settings, including outpatient facilities providing level II anesthesia services. The bill strengthens oversight and safety by requiring that only adult stem cells meeting FDA good manufacturing practices be used in treatments and that more high quality institutional review boards may be accessed to oversee such treatments, including those registered by the United States Department of Health and Human Services Office for Human Research Protection. Additionally, the institutional review boards must report serious adverse events related to the treatments to the Texas Medical Board. S.B. 1827 provides for additional transparency by ensuring that patient's informed consent document gives notice that the treatment is not FDA approved. By improving access to innovative medical treatments while maintaining necessary safeguards, S.B. 1827 aims to enhance treatment options for patients in Texas.

H.B. 5147 amends current law relating to investigational stem cell treatment.

RULEMAKING AUTHORITY

This bill does not expressly grant any additional rulemaking authority to a state officer, institution, or agency.

SECTION BY SECTION ANALYSIS

SECTION 1. Amends Section 1003.051(1), Health and Safety Code, to redefine "investigational stem cell treatment."

SECTION 2. Amends Section 1003.054(c), Health and Safety Code, as follows:

(c) Requires that the informed consent form adopted by the executive commissioner of the Health and Human Services Commission under Section 1003.054 (Informed Consent) provide notice of certain facts, including that the investigational stem cell treatment has not been approved for general use by the United States Food and Drug Administration. Makes nonsubstantive changes.

SECTION 3. Amends Sections 1003.055(a) and (d), Health and Safety Code, as follows:

(a) Requires that treatment provided under Subchapter B (Provision of Investigational Stem Cell Treatments to Patients with Certain Severe Chronic Diseases or Terminal Illnesses) meet certain requirements, including being provided at certain locations, including an outpatient setting, as defined by Section 162.101 (Definition), Occupations Code, listed by a physician registered under Section 162.104 (Registration Required), Occupations Code, to provide level II anesthesia services in that setting. Makes nonsubstantive changes.

(d) Requires an institutional review board that oversees investigational stem cell treatments administered under this subchapter to meet one of certain conditions, including being registered by the United States Department of Health and Human Services, Office for Human Research Protections, in accordance with 21 C.F.R. Part 56. Makes nonsubstantive changes.

SECTION 4. Amends Section 1003.059(b), Health and Safety Code, as follows:

(b) Requires each institutional review board overseeing an investigational stem cell treatment under this subchapter to submit to the Texas Medical Board an annual report on any serious adverse events related to the treatment and the review board's findings based on records kept under Subsection (a) (relating to requiring documentation of investigational stem cell treatments and any effects on the recipient).� Deletes existing text requiring that the report be made available to the public in both written and electronic form. Makes a nonsubstantive change.

SECTION 5.� Effective date: September 1, 2025.