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Personalised maxillofacial bone regeneration

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.
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Coordinator

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE

Address

Rue De Tolbiac 101
75654 Paris

France

Activity type

Research Organisations

EU Contribution

€ 812 287,50

Participants (11)

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UNIVERSITETET I BERGEN

Norway

EU Contribution

€ 812 239,75

SORLANDET SYKEHUS HF

Norway

EU Contribution

€ 167 125

UNIVERSIDAD COMPLUTENSE DE MADRID

Spain

EU Contribution

€ 157 128,75

CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES

France

EU Contribution

€ 160 781,25

UNIVERSITAT INTERNACIONAL DE CATALUNYA

Spain

EU Contribution

€ 139 531,25

UNIVERSITAET ULM

Germany

EU Contribution

€ 1 382 173,75

ETABLISSEMENT FRANCAIS DU SANG

France

EU Contribution

€ 1 552 938,75

SYDDANSK UNIVERSITET

Denmark

EU Contribution

€ 302 800,25

ASSISTANCE PUBLIQUE HOPITAUX DE PARIS

France

EU Contribution

€ 142 062,50

MIMETIS BIOMATERIALS SL

Spain

EU Contribution

€ 320 596,25

INSTITUT STRAUMANN AG

Switzerland

Project information

Grant agreement ID: 779322

Status

Ongoing project

  • Start date

    1 January 2018

  • End date

    31 December 2021

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 5 975 915

  • EU contribution

    € 5 949 665

Coordinated by:

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE

France