PHC-15-2015 - Clinical research on regenerative medicine
Specific challenge: Translating basic knowledge on regenerative medicine into the clinic is held up by the difficulty in undertaking ‘first in man’ studies. Specific research is needed for proving safety, efficacy and repeatability of new treatments. The, very often iterative, dialogue between the relevant authorities and those developing regenerative medicine approaches is needed before specific regulatory requirements can be established.
As a new therapeutic field lacking established business models, financing is a particular obstacle to clinical-stage research in regenerative medicine. The challenge is to initiate a specific action to overcome this hurdle to in-patient research and to determine the potential of new regenerative therapies.
Scope: Proposals should focus on regenerative medicine therapies which are ready for clinical (in-patient) research. Proposals should have at the time of proposal submission the necessary ethical and regulatory authorisations to carry out the work or provide evidence of regulatory engagement and that such approval is close. Preference will be given to proposals which have or 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. Clinical work should represent a central part of the project.
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.
· Obtain results of in-patient regenerative medicine research so that new therapies can be taken to the next level of testing or, if not successful, can be discarded.
· 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 to develop new therapeutic options.
· Lever existing investments in fundamental research in regenerative medicine.
· New approaches to currently untreatable diseases.
Type of action: Research and innovation actions