 |
ARIZONA STATE SENATE
Fifty-Seventh Legislature, Second Regular Session
stem cells; birth tissue; therapy
Purpose
Establishes requirements and restrictions governing the use of stem cell and birth tissue therapies, including prohibitions and penalties relating to the use of cells derived from an aborted fetus or embryo.
Background
Stem cells are undifferentiated cells that can develop into many different cell types in the body and have the ability to self-renew and recreate functional tissues. Pluripotent stem cells, including human embryonic stem cells (hESCs) and induced pluripotent stem cells (iPSCs), can differentiate into all cell types of the adult body. Adult stem cells, or somatic stem cells, generally differentiate into the tissue type from which they are derived. hESCs are obtained from the inner cell mass of preimplantation human embryos, while iPSCs are derived from adult cells that have been reprogrammed to function similarly to embryonic stem cells. Adult stem cells may be obtained from a patient, a donor or certain birth tissues (NIH).
The U.S. Food and Drug Administration (FDA) is the federal agency that oversees clinical research, trials and therapeutic use of stem cell and birth tissue products. Stem cell therapies derived from pluripotent stem cells, adult stem cells or birth tissue may be studied in clinical trials under FDA oversight. To be approved for treatment, stem cell products generally must undergo clinical testing under an Investigational New Drug application and receive FDA approval for being marketed (FDA).
Current statute prohibits a person from using an aborted fetus or embryo, or any part of the fetus or embryo, in animal or human research or transplantation, except for pathological studies or diagnostic purposes to assess the health of the fetus or embryo (A.R.S. § 36-2302).
There is no anticipated fiscal impact to the state General Fund associated with is legislation.
Provisions
1. Prohibits medical doctors or doctors of osteopathic medicine (physicians) from performing or participating in any stem cell or birth tissue therapy involving cells or tissues derived from an aborted fetus or embryo.
2. Makes it a class 5 felony for a physician to willfully perform or actively participate in:
a) treatment or research using human cells or tissues derived from a fetus or an embryo after an elective abortion; or
b) the development, deployment, sale, manufacture or distribution of computer products created using human cells or tissues or cellular or tissue-based products, including synthetic cognition systems.
3. Allows a physician to perform stem cell therapy or birth tissue therapy that is not approved by the FDA if the therapy is:
a) within the physician's lawful scope of practice;
b) related to orthopedics, wound care or pain management; and
c) the cells or tissue being used:
i. are retrieved, processed and stored in a facility that is registered and regulated by the FDA or certified or accredited by the National Marrow Donor Program, the World Marrow Donor Association, the Association for the Advancement of Blood and Biotherapies or the American Association of Tissue Banks;
ii. if stem cells, contain viable or live cells on post-thaw analysis and are accompanied by a post-thaw- viability analysis report provided to the physician before use with a patient; and
iii. if birth tissue, contains naturally occurring growth factors and extracellular matrix elements that meet predetermined release criteria and are accompanied by a certificate indicating that the birth tissue meets the criteria and has tested negative for communicable diseases.
4. Prohibits an individual from obtaining stem cells or birth tissue from any facility that does not have a valid certification or accreditation, as specified.
5. Requires any contract or agreement through which a physician obtains stem cells or birth tissue from a facility to include:
a) the name and address of the facility;
b) the facility's certifying or accrediting organization;
c) the type and scope of certification or accreditation;
d) the effective date and expiration date of the certification or accreditation;
e) any limits or conditions imposed by the certifying or accrediting organization on the facility; and
f) a statement indicating how, when and where the cells or tissue were obtained, such as adult stem cells, umbilical cord blood or amniotic fluid.
6. Requires any facility that provides cells or tissues to a physician for stem cell therapy or birth tissue therapy to notify the physician of any change in certification or accreditation status within 30 days of the change.
7. Requires physicians to ensure that all products used in stem cell therapy or birth tissue therapy are obtained from a facility that complies with good manufacturing practices in accordance with the federal Food, Drug and Cosmetic Act.
8. Requires any physician advertising stem cell therapies or birth tissue therapies to include a specified disclosure in any advertisement.
9. Requires a physician, before performing any stem cell therapy or birth tissue therapy, to obtain a signed informed consent form from the patient or patient's authorized representative that states:
a) the nature and character of the proposed treatment;
b) that the treatment has not been approved by the FDA;
c) the anticipated results of the proposed treatment;
d) possible risks, benefits and alternatives to the treatment, including the option of not undergoing treatment; and
e) that the patient is encouraged to consult with the patient's primary care provider before proceeding with the treatment.
10. Exempts a physician from requirements governing stem cell and birth tissue use if the physician:
a) has obtained FDA approval for an investigational new drug or device for the use of human cells or tissues or cellular or tissue-based products; or
b) perform stem cell therapy or birth tissue therapy treatments under an employment or other contract on behalf of an institution that is certified or accredited by the Foundation for the Accreditation of Cellular Therapy, the Blood and Marrow Transplant Clinical Trials Network or the Association for the Advancement of Blood and Biotherapies.
11. Allows any individual who receives a stem cell therapy or birth tissue therapy that violates requirements relating to stem cell and birth tissue use to bring a civil action to recover statutory damages in an amount of $10,000 per violation, plus attorney fees and costs.
12. Allows the Arizona Medical Board and the Board of Osteopathic Examiners in Medicine and Surgery to adopt rules necessary to implement the outlined requirements for stem cell therapy and birth tissue therapy.
13. Defines terms.
14. Designates this legislation as the Arizona Stem Cell Therapy Act.
15. Becomes effective on the general effective date.
Prepared by Senate Research
February 16, 2026
MM/MS/hk