The objectives of REBORNE is to perform multi-centre clinical trials using advanced biomaterials and cells from autologous or allogeneic sources. 5 clinical trials in orthopedic and maxillofacial surgery will take place in 12 clinical centers spread over 8 European countries. A large consortium of 24 participants with top world class laboratories, SME’s manufacturing biomaterials, GMP- cells producing facilities and hospitals will collaborate to reach these ambitious clinical targets.
The project REBORNE for ‘Regenerating Bone defects using new biomedical Engineering approaches’ has been accepted by the European Commission in the thematic area Health of the 7th Framework Program. Coordinated by Inserm supported by Alcimed for the project management, this large scale integrated project has started 1/10 with a budget of 12 M E over 5 years.
Bone is the most frequently transplanted human tissue with about 1 M procedures annually in the EU. Either autologous or allogeneic bone grafts are primary used by orthopedic or maxillofacial surgeons to reconstruct large bone defects. However, these bone grafts have drawbacks such as a 2nd surgical site with complications, limited quantity and possible immunological reactions. Human mesenchymal stem cells from bone marrow or adipose tissue have a great potential for bone regeneration. Significant growth opportunities exist for synthetic biomaterials in association with mesenchymal stem cells as bone tissue engineered substitutes.