The European Commission Scientific Framework
Several tens of millions of European citizens are partially edentulous and have insufficient bone for placement of dental implants. Following the 7th Framework Program (FP7) of the European Commission 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.
Maxibone Clinical Trial
In this context, the project’s late stage clinical trial aims 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 is to 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. Additionally, 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.
Mimetis Biomaterials in the Maxibone project
Mimetis, the innovative biomaterial SME 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.
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement Number 779322. And thanks to this generous contribution, Mimetis achieved several milestones that we list below:
- Mimetis obtained the license as a 3D printed manufacturer for patient specific implants.
- Mimetis included this new product in its internal Quality Management System (QMS) and in its ISO13485 certification.
- Mimetis found a clinically suitable packaging for cell seeding with the 3D printed scaffolds.
- Mimetis was able to improve the mechanical properties of the scaffold by four folds to be able to use the scaffolds with osteosynthesis material.