Regenerative medicine comprises various novel approaches to health care, representing a complex and heterogenous group of products, including those based on cell and gene therapy, aimed at tissue regeneration and repair. In this report, the European Academies’ Science Advisory Council (EASAC) and the Federation of European Academies of Medicine (FEAM) explore opportunities and challenges for regenerative medicine in the EU, focusing particularly on stem cells but also drawing more general conclusions for the field, with the objective of raising awareness and catalysing action by the scientific community, regulators, health services and public policy-makers.

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