HB 5147 Texas House · 89th Legislature (2025)

Relating to investigational stem cell treatment.

HB 5147 defines "investigational stem cell treatment" as adult stem cell therapy in clinical trials not yet approved by the FDA. It requires clinics to provide clear informed consent disclosing the FDA status of the treatment and mandates that such treatments be administered only by physician-certified providers at specified locations (hospitals, surgical centers, medical schools, or accredited outpatient settings). The bill also sets strict standards for institutional review boards overseeing these trials, requiring affiliation with medical schools, large hospitals, or accreditation by recognized bodies. These requirements aim to ensure transparency and safety for patients participating in stem cell clinical trials in Texas.
Bill status passed 3 of 5 stages cleared
Introduction
Apr 2025
Committee Review
May 2025
House Passage
May 2025
Senate Passage
Governor
Introduced Apr 7, 2025 Last action May 21, 2025
Maddy AI version diff · 1 comparison

What changed between versions

Introduced Engrossed · 5 edits · May 7, 2025
MODERATE
This bill defines investigational stem cell treatment and sets requirements for who can administer it, where it can be provided, and how it must be overseen. The changes clarify that such treatments must be part of clinical trials, use FDA-registered adult stem cells following good manufacturing practices, and be administered only by certified physicians at specific licensed facilities. Institutional review boards must meet strict accreditation or registration standards to oversee these trials.
Scope change
The bill maintains its focus on investigational stem cell treatments but clarifies eligibility criteria for facilities and oversight bodies, ensuring treatments occur only in regulated clinical trial settings.
DEFINITION

Added definition requiring investigational stem cell treatment to use only adult stem cells that satisfy current good manufacturing practices adopted by the FDA.

REQUIREMENT

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.

ELIGIBILITY

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.

Floor votes · House May 7, 2025

How they voted

1411
Passed · 1 other
Total votes 143
May 7, 2025
D Democratic60
60 Yea
100% Yea
R Republican83
81 Yea 1 Nay 1
97% Yea
Vote distribution
All Yea All Nay Mixed No data
Full legislative history

Actions timeline

Total actions
31
Key actions
9
Committee
9
May 21, 2025
Upper · Passed
Left pending in committee
upper
May 21, 2025
Upper · Passed
Testimony taken in committee
upper
May 16, 2025
Committee
Referred to Health & Human Services
upper
May 16, 2025
Introduced
Read first time
upper
May 7, 2025
Introduced
Received from the House
upper
May 7, 2025
Lower · Passed
Passed
lower
May 6, 2025
Lower · Passed
Passed to engrossment
lower
Apr 30, 2025
Lower · Passed
Committee report sent to Calendars
lower
Apr 29, 2025
Lower · Passed
Committee report distributed
lower
Apr 24, 2025
Lower · Passed
Reported favorably w/o amendment(s)
lower
Apr 21, 2025
Lower · Passed
Left pending in committee
lower
Apr 21, 2025
Lower · Passed
Testimony taken/registration(s) recorded in committee
lower
Apr 7, 2025
Committee
Referred to Public Health
lower
Apr 7, 2025
Introduced
Read first time
lower
4 primary · 1 co-sponsor

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