Why GAO did this study. Regenerative medicine represents a paradigm shift in the medical field because it aims to restore or supplement function, rather than just treating symptoms, and opens the door for personalized therapies. GAO conducted an assessment of current and emerging regenerative medicine technologies and therapeutic applications. This report examines (1) current and emerging regenerative medicine technologies and therapies and their potential benefits, (2) challenges that hinder their development and use, and (3) policy options that could help enhance benefits and mitigate challenges associated with these technologies and therapies. GAO reviewed scientific and policy literature and other key reports; convened a 3-day expert meeting; and interviewed subject matter experts and stakeholder groups including government agencies, such as the Department of Health and Human Services, non-government organizations, industry, academia, end user groups such as patient groups. GAO is identifying policy options in this report.
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