Regenerative medicine: from new insights to new applications

Regenerative medicine replaces or regenerates human cells, tissue or organs, to restore or establish normal function. Projects should focus on innovative translational research to develop regenerative processes towards the ultimate clinical goal of addressing unmet clinical needs of large patient groups. Proposals should be based on new approaches such as genome editing or gene therapy, transdifferentiation or in vivo reprogramming, cell therapy and transplantation, 3D bioprinting, organoids or use of combined products (non-exhaustive list for illustrative purposes only). In all cases, proposals should explain in what way their approach is regenerative. Research on improved methods of tissue and organ transplantation is included on the condition that there is a clear regenerative step in the process. The project may focus on any step(s) on the innovation chain, from early testing and characterization of regenerative mechanisms to preclinical research, proof of concept or clinical trial. Sex and gender differences should be investigated, where relevant. Projects should include a section on the proposed therapy's exploitation potential, regulatory and commercialisation strategy and how it would be made available and delivered to patients.

The Commission considers that proposals requesting a contribution from the EU of between EUR 6 and 8 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

Regenerative medicine offers hope for untreatable disease and the ageing population, improved quality of life and reduced medical costs. However, so far, regenerative medicine has not yet proved itself in the clinic beyond rare diseases or conditions of limited public health importance. With recent scientific discoveries opening up new approaches to regenerative medicine, the challenge is to use these to extend the regenerative approach to major diseases and conditions.

• Potential new regenerative therapies to address unmet clinical needs of large patient groups identified.
• Europe's position in translational regenerative medicine strengthened.
• New therapies for major human diseases and conditions, and new approaches for therapy taken further in the development pipeline.