Regenerative Medicine

Regenerative medicine is an emerging medical endeavour aimed at tissue regeneration with small molecule drugs, biological therapies, medical or tissue-engineered devices, or cells and genes. It offers significant promise to tackle intractable diseases and there has been a fast pace of advance in the science, and in commercial interests. The project focuses on stem cells as a case study, to identify opportunities and challenges. Well-characterised approaches may represent significant innovation for, hitherto, unmet medical needs but there are increasing problems of unregulated clinics promising a wide range of benefits on the basis of little evidence and, also, the potential for premature marketing on the basis of insufficient evidence. This project explores what is required to ensure a robust biological and clinical scientific basis, the implications for regulatory frameworks and for supporting education, research and innovation in regenerative medicine in the EU.