Cel
Bone is among the most frequently transplanted tissue with about 1 million procedures annually in Europe. The worldwide market of bone replacement materials is currently estimated at 5 billion € with a 10% annual growth. Despite their considerable disadvantages, including the risk of disease transfer and immunologic rejection, limited supply of bone, costs and complications, allografts and autografts account for more than 80% of total graft volume. Significant growth opportunities exist for synthetic bone grafts in association with mesenchymal stem cells from autologous or allogenic sources as alternatives to biological bone grafts in orthopaedic and maxillofacial surgery. The objectives of REBORNE is to perform clinical trials using advanced biomaterials and cells triggering bone healing in patients. In order to reach this goal, five phase II clinical studies with 20 patients are proposed in 12 clinical centres spread in 8 European countries. Three orthopaedic trials concerning the treatment of long bone fractures and osteonecrosis of the femoral head in adults or children will be conducted using bioceramics, hydrogel for percuteneous injection and stem cells from autologous or allogenic sources. Clinical research will also concern maxillofacial surgery with bone augmentation prior to dental implants and the reconstruction of cleft palates in children. The safety and efficacy of the new therapies will be assessed clinically using X-rays, CT scans and MRI as well as histology of biopsies. These ambitious clinical targets will require research and development efforts from a large consortium of top world class laboratories, SMEs manufacturing biomaterials, GMP-cell producing facilities and surgeons in hospitals as well as the consideration of ethical and regulatory issues. It is expected that REBORNE will expand the competitiveness of Europe through the patenting of new CE-marked bioproducts in the field of regenerative medicine.
Dziedzina nauki
Zaproszenie do składania wniosków
FP7-HEALTH-2009-single-stage
Zobacz inne projekty w ramach tego zaproszenia
System finansowania
CP-IP - Large-scale integrating projectKoordynator
75654 Paris
Francja
Zobacz na mapie
Uczestnicy (23)
93210 La Plaine Saint Denis
Zobacz na mapie
44360 Vigneux De Bretagne
Zobacz na mapie
75015 PARIS 15
Zobacz na mapie
20122 Milano
Zobacz na mapie
Zakończenie uczestnictwa
44093 Nantes
Zobacz na mapie
75012 Paris
Zobacz na mapie
4040 HERSTAL
Zobacz na mapie
3723 MB Bilthoven
Zobacz na mapie
08034 Barcelona
Zobacz na mapie
28049 Madrid
Zobacz na mapie
41121 Modena
Zobacz na mapie
300041 Timisoara
Zobacz na mapie
37044 Tours Cedex 9
Zobacz na mapie
72074 Tuebingen
Zobacz na mapie
89081 Ulm
Zobacz na mapie
37129 Verona
Zobacz na mapie
75016 PARIS
Zobacz na mapie
5020 Bergen
Zobacz na mapie
3584 CX Utrecht
Zobacz na mapie
40136 Bologna
Zobacz na mapie
80539 Munchen
Zobacz na mapie
50139 Firenze
Zobacz na mapie
4000 Liege
Zobacz na mapie