bill changing rules for investigational stem cell treatment

The text as introduced · 541 words

89R12486 MCF-F

By: King
H.B. No. 5147

A BILL TO BE ENTITLED

AN ACT

relating to investigational stem cell treatment.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:

SECTION 1. Section 1003.051(1), Health and Safety Code, is

amended to read as follows:

(1) "Investigational stem cell treatment" means an

adult stem cell treatment that:

(A) is under investigation in a clinical trial

and being administered to human participants in that trial; [ and ]

(B) has not yet been approved for general use by

the United States Food and Drug Administration ; and

(C) uses only adult stem cells that satisfy

current good manufacturing practices adopted by the United States

Food and Drug Administration .

SECTION 2. Section 1003.054(c), Health and Safety Code, is

amended to read as follows:

(c) The executive commissioner by rule shall adopt a form

for the informed consent under this section. The form must provide

notice that :

(1) the department administers this subchapter ; and

(2) the investigational stem cell treatment has not

been approved for general use by the United States Food and Drug

Administration .

SECTION 3. Sections 1003.055(a) and (d), Health and Safety

Code, are amended to read as follows:

(a) Treatment provided under this subchapter must be:

(1) administered directly by a physician certified

under Subsection (c);

(2) overseen by an institutional review board

described by Subsection (d); and

(3) provided [ at ]:

(A) at a hospital licensed under Chapter 241;

(B) at an ambulatory surgical center licensed

under Chapter 243; [ or ]

(C) at a medical school, as defined by Section

61.501, Education Code ; or

(D) in an outpatient setting, as defined by

Section 162.101, Occupations Code, listed by a physician registered

under Section 162.104, Occupations Code, to provide level II

anesthesia services in that setting .

(d) An institutional review board that oversees

investigational stem cell treatments administered under this

subchapter must meet one of the following conditions:

(1) be affiliated with a medical school, as defined by

Section 61.501, Education Code;

(2) be affiliated with a hospital licensed under

Chapter 241 that has at least 150 beds;

(3) be accredited by the Association for the

Accreditation of Human Research Protection Programs;

(4) be 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; [ or ]

(5) be accredited by a national accreditation

organization acceptable to the Texas Medical Board ; or

(6) be 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 .

SECTION 4. Section 1003.059(b), Health and Safety Code, is

amended to read as follows:

(b) Each institutional review board overseeing an

investigational stem cell treatment under this subchapter shall

submit to the Texas Medical Board an annual report on any serious

adverse events related to the treatment and [ to the Texas Medical

Board on ] the review board's findings based on records kept under

Subsection (a). The report may not include any patient identifying

information [ and must be made available to the public in both

written and electronic form ].

SECTION 5. This Act takes effect September 1, 2025.