Stem Cell Therapy

Added requirement that stem cell facilities must provide post-thaw viability analysis reports to physicians before use, ensuring cell quality and safety.

Removed requirement that stem cell facilities must be certified by specific organizations (National Marrow Donor Program, World Marrow Donor Association, etc.) and replaced with broader FDA registration and certification/accreditation requirements.

Added requirement that physicians must notify facilities within 30 days of any changes in certification or accreditation status.

Added criminal penalties (third-degree felony) for physicians who willfully perform treatment using abortion-derived cells or distribute computer products created with human cells.

Modified the definition of stem cell therapy to specifically include afterbirth placental perinatal stem cells and exclude adipose-derived mesenchymal stem cells from regulation.

Modified the definition of human cells/tissues to remove specific exclusions for cord blood donors and expand the list of excluded products.

Added requirement that stem cells must contain viable or live cells upon post-thaw analysis and include a viability report sent to the physician before patient use.

Added the American Association of Tissue Banks as an additional entity for facility registration alongside the National Marrow Donor Program, World Marrow Donor Association, and Association for the Advancement of Blood and Biotherapies.

Modified the consent form requirement to explicitly state that the patient must be encouraged to consult with their primary care provider before undergoing stem cell therapy.

Modified the rule adoption requirement to specify that the Board of Medicine shall adopt rules in consultation with the Board of Osteopathic Medicine, reversing the original order of responsibility.

Modified disciplinary action language to specify that violations are subject to disciplinary action under rules developed by the board or department, rather than general disciplinary action.

Changed from creating a single statute for all health care providers to creating two separate statutes: one for physicians (458.3245) and one for osteopathic physicians (459.0127).

Added the American Association of Tissue Banks as an additional approved entity for stem cell facility registration/licensing.

Changed rule adoption authority from the Department of Health to the Board of Medicine and Board of Osteopathic Medicine, with each board adopting rules in consultation with the other.

Added specific language clarifying that violations may be subject to disciplinary action under rules developed by the relevant board or department.