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Personalised maxillofacial bone regeneration

Cel

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.

Zaproszenie do składania wniosków

H2020-SC1-2016-2017

Zobacz inne projekty w ramach tego zaproszenia

Szczegółowe działanie

H2020-SC1-2017-Single-Stage-RTD

Koordynator

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
Wkład UE netto
€ 916 821,86
Adres
RUE DE TOLBIAC 101
75654 Paris
Francja

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Region
Ile-de-France Ile-de-France Paris
Rodzaj działalności
Research Organisations
Linki
Koszt całkowity
€ 916 821,86

Uczestnicy (13)