Georgia Joins Utah, Florida, and Other States in “Legalizing” Birth Tissue-Derived Stem Cell Therapies
Georgia’s House Bill 1275 allows physicians and others to provide non-FDA-approved stem cell therapies derived from ethically sourced birth tissues, while imposing facility standards, disclosure rules, and patient consent requirements.
Key Points
- Georgia has enacted House Bill 1275, allowing physicians and certain designated physician assistants or nurse practitioners to provide some stem cell therapies that are not approved by the FDA.
- The law covers birth tissue-derived products, including afterbirth placental perinatal stem cells and umbilical cord Wharton’s jelly mesenchymal stem cells, while excluding cells or tissues derived from an aborted fetus or embryo.
- Utah, Florida, and other states have passed similar laws, with requirements for patient consent, provider disclosures, sourcing standards, and facility oversight.
Georgia has enacted House Bill 1275, creating a new section in state medical practice law for certain stem cell therapies. The law allows a physician or a lawfully designated physician assistant or nurse practitioner to perform stem cell therapy that is not FDA-approved if the treatment is within that provider’s scope of practice and the patient signs a consent form.
The law, similar to the other states, is framed around the use of ethically obtained sources that do not involve cells derived from aborted fetuses. It defines stem cell therapy to include afterbirth placental perinatal stem cells and certain human cells, tissues, or cellular or tissue-based products that meet the section’s requirements.
The law excludes treatment or research using human cells or tissues derived from an aborted fetus or embryo. It also sets out definitions for terms such as minimally manipulated and human cells, tissues, or cellular or tissue-based products, while carving out some materials from that category.
What will be interesting to hear is if “minimally manipulated” will follow the federal precedent set in 2012 via FDA vs Regenexx, which found that culture-expansion of MSCs is not considered minimally manipulated. As of now, the Florida law also mentions minimal manipulation; however, companies are openly using expanded cells.
Oversight, Consent, and Facility Standards
The law requires stem cells used under the section to be retrieved, manufactured, and stored in a Georgia facility that is either registered with the FDA or certified or accredited by an approved organization such as:
- National Marrow Donor Program
- World Marrow Donor Association
- Association for the Advancement of Blood and Biotherapies
- American Association of Tissue Banks
- Another entity the Georgia Department of Public Health determines is appropriate
It also includes patient protection measures covering notice, informed consent, and advertising, and it allows for disciplinary action if providers do not comply with the section’s requirements.
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