Bill would let Arizona providers offer unapproved stem cell therapies under safety, consent, and sourcing rules

A new article would allow licensed health professionals to perform stem cell or regenerative therapy that the FDA has not approved. It covers health professionals licensed under title 32 whose scope of practice includes the therapy, using cells or materials from adult donors or afterbirth sources such as placental cells, perinatal cells, amniotic fluid, or umbilical cord blood. The provider must complete a nationally recognized, accredited, or board-recognized continuing education training in the therapy. The therapy must follow the sourcing rules and the provider must get written informed consent first.

Providers may only use stem cells or regenerative products from certified or accredited manufacturing facilities and must document the source. It covers providers and the manufacturing facilities that supply them. Accrediting groups named include the World Marrow Donor Association, the Association for the Advancement of Blood and Biotherapies, the American Association of Tissue Banks, and the American Academy of Stem Cell Medicine. Suppliers must give lot-specific sterility reports and certificates of analysis before use, and must notify the provider within thirty days of any change in certification. Suppliers must give notice within thirty days after a change in certification status.

Providers must get signed informed consent, include a required notice in advertising, keep treatment records, and report serious adverse events. It covers providers, their patients, and the health profession boards that license providers. Consent must state the treatment's nature, that the FDA has not approved it, expected results, serious risks and alternatives, and a suggestion to consult a primary care provider. A provider acting in good faith and following the rules is not disciplined solely for giving the therapy, except in cases of gross negligence, medical fraud, or intentional misconduct. Patients treated in violation may sue for statutory damages of $10,000 per violation plus attorney fees and costs. Serious adverse events must be reported to the licensing board within fifteen calendar days of the provider learning of them.