Objective
Several tens of millions of European citizens are partially edentulous and have insufficient bone for placement of dental implants. Following FP7 REBORNE project on bone regeneration, the MAXIBONE consortium coordinated by INSERM wishes to perform a randomized controlled clinical trial on alveolar ridge augmentation in mandibular and maxillary bone. This late stage clinical trial will aim at comparing the safety and efficacy of autologous bone grafting (gold standard) with culture expanded autologous bone marrow mesenchymal stem cells (MSCs) associated to a synthetic bone substitute covered by a resorbable membrane in 150 patients. The recruitment will be performed in 10 major hospital centres while the production of MSC will be done in the German and French blood transfusion institutes. Medical imaging, direct measurements and histology of core biopsies before dental implants will ensure the evaluation of bone regeneration. Cost-effective monitoring using a secured internet platform (eCRF) will produce a clinical database for evaluation of safety, efficacy and health costs in both arms. The participation of the innovative biomaterial SME Mimetis and the industrial leader in dental implantology Straumann will further contribute to the dissemination and exploitation strategies of future personalized regenerative medicine treatments in Europe.
Fields of science
- medical and health sciencesclinical medicineodontologydental implantology
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugs
- medical and health sciencesmedical biotechnologycells technologiesstem cells
- engineering and technologyindustrial biotechnologybiomaterials
- medical and health sciencesmedical biotechnologyimplantsartificial bone
Keywords
Programme(s)
Funding Scheme
RIA - Research and Innovation actionCoordinator
75654 Paris
France