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ARIZONA STATE SENATE
Fifty-Seventh Legislature, Second Regular Session
AMENDED
stem
cells; birth tissue; therapy
(NOW: stem cells; regenerative therapy)
Purpose
Establishes regulations
governing the use of stem cell and regenerative therapies that are not approved
by the U.S. Food and Drug Administration (FDA).
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 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).
There is no anticipated fiscal impact to the state General Fund associated with is legislation.
Provisions
1. Allows a provider to perform stem cell or regenerative therapy that is not approved by the FDA if the therapy is:
a) within the provider's lawful scope of practice;
b) the provider has completed nationally-recognized, accredited or board-recognized continuing education training in stem cell or regenerative therapy;
c) the therapy complies with outlined sourcing requirements;
d) the provider obtains outlined written informed consent; and
e) the cells, exosomes or biologic materials being used are:
i. sourced exclusively from a facility that is registered, certified or accredited and inspected and that complies with current good manufacturing practice standards;
ii. retrieved, manufactured and stored in a facility that is registered, regulated and inspected 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, the American Academy of Stem Cell Medicine or the American Association of Tissue Banks; and
iii. supplied by the manufacturer with appropriate validation of isolation techniques, including cell viability and surface marker reports for cellular products, viscosity report for Wharton's jelly, exosome counts for exosome-based regenerative products, lot-specific sterility reports and certificates of analysis.
2. Prohibits a provider from obtaining stem cells or regenerative medicines from any facility that does not have a valid certification or accreditation, as specified.
3. Requires any contract or agreement through which a provider obtains stem cells or regenerative medicines from a facility to include:
a) the name and address of the manufacturing facility;
b) the manufacturing facility's certifying or accrediting organization;
c) proof of certification or accreditation;
d) proof of site inspection by the FDA or a specified certifying or accrediting organization;
e) the type and scope of certification or accreditation;
f) the effective date and expiration date of the certification or accreditation;
g) any limits or conditions imposed by the certifying or accrediting organization on the facility; and
h) a statement indicating how, when and where the cells were obtained, such as adult stem cells, umbilical cord blood or amniotic fluid.
4. Requires any manufacturing facility that provides cells or regenerative medicine to a provider for stem cell or regenerative therapy to notify the provider of any change in certification or accreditation status within 30 days of the change, including suspension, revocation, renewal or expiration.
5. Requires a provider to ensure that all products used in stem cell or regenerative therapies are obtained from a facility that complies with good manufacturing practices in accordance with the federal Food, Drug and Cosmetic Act.
6. Requires any provider advertising stem cell or regenerative therapies to include a specified disclosure in any advertisement.
7. Requires a provider, before performing any stem cell or regenerative 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.
8. Requires a provider administering a stem cell or regenerative therapy to maintain accurate treatment records and document any clinical outcomes or adverse events, as specified.
9. Requires a provider administering a stem cell or regenerative therapy to report any serious adverse events to:
a) the provider's respective health profession regulatory board within 15 days after becoming aware of the event, if the event is reasonably suspected to be linked to the therapy; and
b) the supplier of the stem cell or regenerative therapy.
10. Allows a provider to voluntarily submit de-identified data to professional clinical registries.
11. Deems it an act of unprofessional conduct for a provider to violate requirements relating to stem cell and regenerative therapy.
12. Exempts a licensed provider who acts in good faith and in compliance with stem cell and regenerative therapy requirements from being subject to professional disciplinary action or license revocation, except in cases of gross negligence, medical fraud or intentional misconduct.
13. Allows any individual who receives a stem cell or regenerative therapy treatment that violates applicable statutory requirements to bring a civil action to recover statutory damages in an amount of $10,000 per violation, plus attorney fees and costs.
14. Defines provider as any health professional who is licensed pursuant to A.R.S. Title 32 and whose scope of practice includes stem cell or regenerative therapy.
15. Defines stem cell or regenerative therapy as a treatment that involves the use of afterbirth, including placental cells or other cells, tissues or amniotic fluid, that may be autologous, allogenic or culture expanded and that complies with statutory requirements.
16. Designates this legislation as the Arizona Stem Cell and Regenerative Therapy Act.
17. Contains a statement of legislative intent.
18. Becomes effective on the general effective date.
Amendments Adopted by Committee of the Whole
1. Removes provisions prohibiting the use of cells or tissues derived from an aborted fetus or embryo and eliminates related felony penalties.
2. Expands stem cell and regenerative therapy requirements to apply to any licensed health professional with appropriate scope of practice.
3. Removes the stipulation that stem cell therapy or birth tissue therapy be related to orthopedics, wound care, or pain management.
4. Adds training, sourcing and informed consent requirements for a provider to perform stem cell or regenerative therapies.
5. Requires that any cells, exosomes or biologic materials used for therapeutic purposes are sourced from outlined facilities operating in compliance with good manufacturing practice standards.
6. Adds the American Academy of Stem Cell Medicine to the list of organizations that facilities sourcing stem cells or regenerative medicines may be certified or accredited by to meet certification and accreditation requirements.
7. Requires that facilities sourcing stem cells or regenerative medicines be inspected by the FDA or other outlined organizations.
8. Requires any contract or agreement through which a provider obtains stem cells or birth tissue from a facility to additionally include:
a) proof of certification or accreditation; and
b) proof of site inspection by the FDA or a specified certifying or accrediting organization.
9. Requires stem cells or regenerative medicines being used for therapeutic purposes to be manufactured, rather than processed, in outlined facilities.
10. Replaces product-specific biologic material validation requirements with manufacturer-supplied validation and documentation requirements.
11. Requires a provider administering a stem cell or regenerative therapy to maintain accurate treatment records and document any clinical outcomes or adverse events.
12. Outlines required reports that a provider administering a stem cell or regenerative therapy must submit regarding clinical outcomes and adverse events.
13. Removes the exemption from requirements governing stem cell and birth tissue therapies for providers that meet outlined conditions.
14. Deems it an act of unprofessional conduct for a provider to violate requirements relating to stem cell and regenerative therapy.
15. Exempts a licensed provider who acts in good faith and in compliance with stem cell and regenerative therapy requirements from being subject to professional disciplinary action or license revocation.
16. Removes the authority for the Arizona Medical Board and the Board of Osteopathic Examiners in Medicine and Surgery to adopt rules relating to stem cell therapy and birth tissue therapy.
17. Replaces the term physician with provider.
18. Replaces the term birth tissue therapy with regenerative therapy.
19. Adds a statement of legislative intent.
20. Modifies defined terms.
21. Makes technical and conforming changes.
Senate Action
HHS 2/18/26 DP 4-3-0
Prepared by Senate Research
March 4, 2026
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