(a) The Legislature recognizes the need for patient
access to innovative medical treatments. At the same time, the health
and welfare of Texas citizens must be protected. These goals must
be carefully balanced.
(b) The purpose of this subchapter is to set out the
requirements for a patient to be eligible for consideration of receiving
investigational stem cell treatment and under what circumstances a
certified physician may administer or provide investigational stem
cell treatments. The implementation of this rule is contingent upon
qualifying chronic diseases or terminal illness being defined, as
set out in §1003.052 of the Texas Health and Safety Code.
(c) This rule does not require an eligible patient
to receive such treatment, but rather the statute sets the eligibility
standards and the parameters under which treatment may be provided
to an individual with a qualifying severe chronic disease or terminal
illness.
(d) Stem cell treatments which are under investigation
in a clinical trial and being administered to human participants:
(1) may be administered or provided to eligible patients
with qualifying terminal illnesses or severe chronic diseases as defined
by the executive commissioner of the Health and Human Services Commission;
and
(2) must be done in compliance with applicable law.
(e) In order for a patient to be eligible to receive
treatment with investigational stem cells, the eligible patient must:
(1) be enrolled in a clinical trial investigating the
use of adult stem cells in humans;
(2) sign a written informed consent, before receiving
treatment, which includes documentation of compliance with §1003.053(2)(a)
of the Texas Health and Safety Code;
(3) receive treatment from a physician certified under §1003.055
of the Texas Health and Safety Code by:
(A) a qualifying IRB;
(B) a medical school as defined by §61.501 of
the Education Code; or
(C) a hospital licensed under Chapter 241 of the Texas
Health and Safety Code; and
(4) receive treatment in a qualifying facility under §1003.055
of the Texas Health and Safety Code.
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