Research should aim to develop regenerative therapies, involve SMEs and test promising products or techniques in the clinic. Since it is intended to encourage regenerative medicine as an approach, proposals may address any justified disease or condition. Execution of clinical/in-patient trials should represent a central part of the project. To indicate real promise, pre-clinical or early clinical results should be already available. Rigorous toxicology studies should precede clinical trials. The biological basis of product mode of action should already be known but may be further developed during the project. Up-scaling, good manufacturing practice (GMP) and regulatory work should.