89R12486 MCF-F
By: Parker S.B. No. 1827
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.