FEAM collaborated on a joint project with EASAC to examine a range of issues for 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 EASAC-FEAM 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.
The press release of the report is available here
A commentary on the report has been published by The Lancet
Cossu, G., Fears, R., Griffin, G., & Ter Meulen, V. (2020). Regenerative medicine: challenges and opportunities. Lancet (London, England), 395(10239), 1746-1747. Full version
A discussion with stakeholders and policymakers was organised by the Biomedical FEAM Forum