News & Events
Inserm: Starting of the European project REBORNE
14 June 2010 10:59:40
Starting of the European project REBORNE aiming at bone defects regeneration using stem cells and biomaterials in 5 multi-centre clinical trials.
Submitted by the end of 2008, 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, this large scale integrated project has started in January 2010 with a budget of 12 millions € over 5 years. Bone is the most frequently transplanted human tissue with about one million procedures annually in Europe. 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 second 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. The objectives of REBORNE is to perform multi-centre clinical trials using advanced biomaterials and cells from autologous or allogeneic sources. Five 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, SMEs manufacturing biomaterials, GMP- cells producing facilities and hospitals will collaborate to reach these ambitious clinical targets.
Contact : Pierre LAYROLLE, Coordinator of REBORNE, Director of Research, Inserm U957, Faculty of medicine, University of Nantes; Tel : +33 (0)2 72 64 11 43 ; pierre.layrolle@inserm.fr
Luc SENSEBE, co-coordinator, Medical and Scientific Director, EFS Centre-Atlantique, Tel : +33 (0)2 47 36 01 98; luc.sensebe@efs.sante.fr
Management: Nadège PENHALEUX-HALET, Project Manager, ALCIMED. Tel: +33 (0)1 44 30 10 32 ; nadege.penhaleux@alcimed.com
REBORNE is partially funded by a grant from the Directorate-General
Inspection classified as N.A.I
5 February 2010 16:17:34
A level 2 baseline QSIT inspection was conducted at BIOMATLANTE from January the 26th to January the 29th, by an investigator from the New England District Office.
All the 4 main subsystems (Management Control, Design Control, CAPA, Production & Process Control) were reviewed.
The inspection was classified as N.A.I. (No Action Indicated).
Chantal Gobin, President
EZ Cure
17 December 2008 14:28:03
EZ Cure ensures a barrier function for a minimum of 3 months in order to prevent connective or epithelial cells from colonising the surgical site during the healing period. Through cross-linking technology the barrier function and the tissue response can be optimised
