stem cells; birth tissue; therapy
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed Senate
- Passed House
- To Governor
- Became Law
Overview
This bill establishes regulations for the practice of stem cell and regenerative therapy in Arizona. It defines key terms, outlines requirements for sourcing cells and tissues from approved facilities, mandates specific informed consent procedures, and regulates advertising practices. The bill aims to ensure patient safety and transparency while allowing qualified providers to offer therapies not yet approved by the FDA.
Key provisions
- Defines ‘Provider’ and ‘Stem cell or regenerative therapy’ for regulatory purposes.
- Requires stem cell and regenerative therapies to be sourced exclusively from registered, certified, or accredited facilities.
- Mandates specific validation requirements for cells and tissues used in therapies.
- Requires providers to obtain signed informed consent forms detailing the nature of the treatment, lack of FDA approval, potential risks, and alternative options.
- Establishes disclosure requirements for advertising stem cell or regenerative therapies.
- Requires providers to maintain accurate treatment records and report adverse events.
- Allows providers to voluntarily submit de-identified patient data to clinical registries.
- Provides for civil action for patients who receive treatments violating the bill's provisions.
Who is affected
- Healthcare providers (specifically, those licensed under Title 32)
Bill text
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Sponsors
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1 on record
Primary sponsor
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