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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.

Call for proposal

H2020-SC1-2017-Single-Stage-RTD
See other projects for this call

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)

UNIVERSITETET I BERGEN
Norway
EU contribution
€ 812 239,75
Address
Museplassen 1
5020 Bergen
Activity type
Higher or Secondary Education Establishments
SORLANDET SYKEHUS HF

Participation ended

Norway
EU contribution
€ 167 125
Address
Egsveien 100
4615 Kristiansand S
Activity type
Research Organisations
UNIVERSIDAD COMPLUTENSE DE MADRID
Spain
EU contribution
€ 157 128,75
Address
Avenida De Seneca 2
28040 Madrid
Activity type
Higher or Secondary Education Establishments
CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES
France
EU contribution
€ 160 781,25
Address
Allee De L'ile Gloriette 5
44093 Nantes
Activity type
Higher or Secondary Education Establishments
UNIVERSITAT INTERNACIONAL DE CATALUNYA
Spain
EU contribution
€ 139 531,25
Address
C Inmaculada 22
08017 Barcelona
Activity type
Higher or Secondary Education Establishments
UNIVERSITAET ULM
Germany
EU contribution
€ 1 382 173,75
Address
Helmholtzstrasse 16
89081 Ulm
Activity type
Higher or Secondary Education Establishments
ETABLISSEMENT FRANCAIS DU SANG
France
EU contribution
€ 1 552 938,75
Address
Avenue Du Stade De France 20
93210 La Plaine Saint Denis
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
SYDDANSK UNIVERSITET
Denmark
EU contribution
€ 302 800,25
Address
Campusvej 55
5230 Odense M
Activity type
Higher or Secondary Education Establishments
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
EU contribution
€ 142 062,50
Address
3 Avenue Victoria
75000 Paris
Activity type
Research Organisations
MIMETIS BIOMATERIALS SL
Spain
EU contribution
€ 320 596,25
Address
Av Universidad Autonoma 23
08290 Cerdanyola Del Valles Barcelona
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
INSTITUT STRAUMANN AG
Switzerland
EU contribution
€ 0
Address
Peter Merian-weg 12
4002 Basel
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)