Bill > HB1275

This bill aims to ensure that human stem cell therapies in Georgia are used ethically to improve patient outcomes, specifically prohibiting the use of stem cells derived from aborted fetuses. It defines key terms like "FDA" (United States Food and Drug Administration), "human stem cell therapy," and "Wharton's jelly" (a type of potent stem cell from umbilical cords). The bill allows physicians, or designated physician assistants or nurse practitioners, to perform stem cell therapies not yet approved by the FDA, provided patients are fully informed and provide written consent. These therapies must use stem cells sourced from facilities registered with the FDA and located in Georgia or elsewhere, or from facilities certified by recognized accrediting bodies such as the World Marrow Donor Association. Facilities must notify physicians of any changes to their certification status, and all therapies must adhere to federal manufacturing practices. Advertisements for these unapproved therapies must include a clear notice informing patients that the treatment is not FDA-approved and recommending consultation with their primary care provider. The bill also outlines specific requirements for the consent form, which must detail the treatment, its unapproved status, and anticipated results. Exceptions are provided for therapies conducted under FDA approval or by institutions accredited by specific organizations. Violations could lead to disciplinary action against the healthcare provider, but the bill clarifies it does not restrict stem cell research conducted in accordance with federal law.