In accordance with Chapter 1003 of the Texas Health and Safety Code, physicians who administer or provide for the use of investigational stem cell treatments must:
- (1) comply with all applicable state and federal laws and rules;
- (2) be certified to administer stem cell in accordance with §1003.055 of the Texas Health and Safety Code;
- (3) ensure the patient is enrolled in a clinical trial investigating the use of adult stem cells in humans;
- (4) maintain adequate medical records including documentation of the patient's qualifying severe chronic disease or terminal illness;
- (5) obtain a signed written informed consent including the patient eligibility determination found in §1003.053(2)(a) of the Texas Health and Safety Code; and
- (6) provide stem cells in a qualifying facility.
Source Note:The provisions of this §170.5 adopted to be effective January 9, 2025, 50 TexReg 349.