SB1214

THE CONTEXT: 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.

WHAT THE BILL DID: Establishes regulations governing the use of stem cell and regenerative therapies that are not approved by the U. S.

WHY IT MATTERED: The practical reason for this bill was to give patients a defined set of rights and a clear informed-consent standard. It would allow 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 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, and would also prohibit a provider from obtaining stem cells or regenerative medicines from any facility that does not have a valid certification or accreditation, as specified, rather than leave the current rule unchanged.