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Regenerative medicine comprises novel interdisciplinary approaches, including several based on cell and gene therapies, aimed at tissue regeneration and repair. All regenerative medicine strategies depend upon harnessing, stimulating, guiding or replacing endogenous developmental or repair processes. Regenerative medicine offers significant promise for treating intractable diseases but, so far, has proved itself in only a few specific clinical indications, for example for haematopoietic and skin disorders. Stem-cell-based medicine is now established and will undoubtedly advance towards treating a progressively larger spectrum of diseases, so it is essential to address some critical scientific issues for evidence-based implementation and regulation. The consequences of not doing this would be to waste investment, researcher activity and aspirations to cure, as well as to undermine patient protection.
This report, from a project conducted by EASAC (European Academies’ Science Advisory Council) and FEAM (Federation of European Academies of Medicine), explores opportunities and challenges in this rapidly advancing field, discusses what principles should be offered for guidance in policy development and what the strategic priorities are in the European Union (EU) for products in the category of advanced therapy medicinal products, which includes those used for regenerative medicine.