Clinical research on regenerative medicine

Proposals should target regenerative medicine therapies which are ready for clinical (in-patient) research and should focus on one specific clinical phase of work. Any stage of clinical work (e.g. first in man, late stage trial, observational study) may be proposed though later stages are preferred; clinical work should represent the core of the proposal. To justify the clinical work proposed, phase I proposals must present appropriate preclinical and toxicology data, and later phase proposals must present appropriate preliminary results.

Proposals should include authorization to conduct clinical trials and ethical approvals or provide evidence of regulatory engagement and that such approval is close. Preference will be given to proposals which are closest to having approvals in place for clinical work to start. Since the objective is to test new regenerative therapies, proposals may address any disease or condition but a justification for the choice must be provided. Proposers should also justify why the therapy proposed is regenerative and how it represents a new approach compared to any existing treatment. Sex and gender differences should be investigated, where relevant. To allow an adequate coverage in the field of regenerative medicine, proposals should take into account the projects previously funded under this topic in Horizon 2020[[Project abstracts will be provided on the call page on the Participant Portal.]].

The Commission considers that proposals requesting a contribution from the EU of between EUR 4 and 6 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

Translating basic knowledge on regenerative medicine into the clinic is often delayed by the difficulty of undertaking ""first in man"" studies and carrying out the specific research needed for proving safety and efficacy of new treatments as well as reproducibility of their therapeutic effect. Moreover, financing for these steps in the new therapeutic field of regenerative medicine is particularly scarce, due to lack of established business and regulatory models. The challenge is to overcome these hurdles to in-patient research and to determine the potential of new regenerative therapies.

• Obtain results by means of in-patient regenerative medicine research that allows new therapies to safely reach the next level of testing or medical practice.
• Stimulate growth and competitiveness of European regenerative medicine including European small and medium-sized enterprises and industry operating in the sector.
• Increase the attractiveness of Europe as a location of choice for development of new therapeutic options.
• Lever existing investments in fundamental research into regenerative medicine.
• Develop new approaches to currently untreatable diseases.