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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-SC1-2016-2017

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Sub call

H2020-SC1-2017-Single-Stage-RTD

Coordinator

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
Net EU contribution
€ 916 821,86
Address
Rue De Tolbiac 101
75654 Paris
France

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Other funding
€ 0,00

Participants (13)

UNIVERSITETET I BERGEN
Norway
Net EU contribution
€ 797 509,14
Address
Museplassen 1
5020 Bergen

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Region
Norge Vestlandet Vestland
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

HELSE BERGEN HF
Norway
Net EU contribution
€ 142 696,25
Address
Jonas Lies Vei 65
5021 Bergen

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Region
Norge Vestlandet Vestland
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
SORLANDET SYKEHUS HF

Participation ended

Norway
Net EU contribution
€ 7 125,00
Address
Egsveien 100
4615 Kristiansand S
Region
Norge Agder og Sør-Østlandet Agder
Activity type
Research Organisations
Other funding
€ 0,00
UNIVERSIDAD COMPLUTENSE DE MADRID
Spain
Net EU contribution
€ 157 128,75
Address
Avenida De Seneca 2
28040 Madrid

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Region
Comunidad de Madrid Comunidad de Madrid Madrid
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES
France
Net EU contribution
€ 160 781,25
Address
Allee De L'ile Gloriette 5
44093 Nantes

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Region
Pays de la Loire Pays de la Loire Loire-Atlantique
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
UNIVERSITAT INTERNACIONAL DE CATALUNYA
Spain
Net EU contribution
€ 139 531,25
Address
C Inmaculada 22
08017 Barcelona

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Region
Este Cataluña Barcelona
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
UNIVERSITAET ULM
Germany
Net EU contribution
€ 1 247 173,75
Address
Helmholtzstrasse 16
89081 Ulm

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Region
Baden-Württemberg Tübingen Ulm, Stadtkreis
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
ETABLISSEMENT FRANCAIS DU SANG
France
Net EU contribution
€ 1 615 438,75
Address
Avenue Du Stade De France 20
93210 La Plaine Saint Denis

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Region
Ile-de-France Ile-de-France Seine-Saint-Denis
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Other funding
€ 0,00
SYDDANSK UNIVERSITET
Denmark
Net EU contribution
€ 302 800,25
Address
Campusvej 55
5230 Odense M

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Region
Danmark Syddanmark Fyn
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
Net EU contribution
€ 142 062,50
Address
3 Avenue Victoria
75000 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Other funding
€ 0,00
MIMETIS BIOMATERIALS SL
Spain
Net EU contribution
€ 260 696,25
Address
Av Universidad Autonoma 23
08290 Cerdanyola Del Valles Barcelona

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Region
Este Cataluña Barcelona
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

UNIVERSITAT POLITECNICA DE CATALUNYA
Spain
Net EU contribution
€ 59 900,00
Address
Calle Jordi Girona 31
08034 Barcelona

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Region
Este Cataluña Barcelona
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
INSTITUT STRAUMANN AG
Switzerland
Net EU contribution
€ 0,00
Address
Peter Merian-weg 12
4002 Basel

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Region
Schweiz/Suisse/Svizzera Nordwestschweiz Basel-Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 26 250,00