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Regenerating Bone defects using New biomedical Engineering approaches

Objective

Bone is among the most frequently transplanted tissue with about 1 million procedures annually in Europe. The worldwide market of bone replacement materials is currently estimated at 5 billion € with a 10% annual growth. Despite their considerable disadvantages, including the risk of disease transfer and immunologic rejection, limited supply of bone, costs and complications, allografts and autografts account for more than 80% of total graft volume. Significant growth opportunities exist for synthetic bone grafts in association with mesenchymal stem cells from autologous or allogenic sources as alternatives to biological bone grafts in orthopaedic and maxillofacial surgery. The objectives of REBORNE is to perform clinical trials using advanced biomaterials and cells triggering bone healing in patients. In order to reach this goal, five phase II clinical studies with 20 patients are proposed in 12 clinical centres spread in 8 European countries. Three orthopaedic trials concerning the treatment of long bone fractures and osteonecrosis of the femoral head in adults or children will be conducted using bioceramics, hydrogel for percuteneous injection and stem cells from autologous or allogenic sources. Clinical research will also concern maxillofacial surgery with bone augmentation prior to dental implants and the reconstruction of cleft palates in children. The safety and efficacy of the new therapies will be assessed clinically using X-rays, CT scans and MRI as well as histology of biopsies. These ambitious clinical targets will require research and development efforts from a large consortium of top world class laboratories, SMEs manufacturing biomaterials, GMP-cell producing facilities and surgeons in hospitals as well as the consideration of ethical and regulatory issues. It is expected that REBORNE will expand the competitiveness of Europe through the patenting of new CE-marked bioproducts in the field of regenerative medicine.
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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

€ 2 121 051,08

Administrative Contact

Marianne Desmedt (Ms.)

Participants (23)

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ETABLISSEMENT FRANCAIS DU SANG

France

EU Contribution

€ 1 439 351,40

BIOMATLANTE

France

EU Contribution

€ 477 500

COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES

France

EU Contribution

€ 224 994

FONDAZIONE IRCCS CA' GRANDA - OSPEDALE MAGGIORE POLICLINICO

Italy

EU Contribution

€ 546 715,54

CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES

France

EU Contribution

€ 99 892,17

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

France

EU Contribution

€ 121 388

KITOZYME SA

Belgium

EU Contribution

€ 300 160

KUROS BIOSCIENCES BV

Netherlands

EU Contribution

€ 401 600

UNIVERSITAT POLITECNICA DE CATALUNYA

Spain

EU Contribution

€ 304 855

UNIVERSIDAD AUTONOMA DE MADRID

Spain

EU Contribution

€ 630 499,50

UNIVERSITA DEGLI STUDI DI MODENA E REGGIO EMILIA

Italy

EU Contribution

€ 803 109,26

UNIVERSITATEA DE MEDICINA SI FARMACIE VICTOR BABES TIMISOARA

Romania

EU Contribution

€ 247 600

CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE DE TOURS

France

EU Contribution

€ 112 050

EBERHARD KARLS UNIVERSITAET TUEBINGEN

Germany

EU Contribution

€ 465 696

UNIVERSITAET ULM

Germany

EU Contribution

€ 1 356 006,42

UNIVERSITA DEGLI STUDI DI VERONA

Italy

EU Contribution

€ 481 199,62

ALCIMED

France

EU Contribution

€ 374 964

UNIVERSITETET I BERGEN

Norway

EU Contribution

€ 409 868,75

UNIVERSITAIR MEDISCH CENTRUM UTRECHT

Netherlands

EU Contribution

€ 199 940

ISTITUTO ORTOPEDICO RIZZOLI

Italy

EU Contribution

€ 363 180

MAX-PLANCK-GESELLSCHAFT ZUR FORDERUNG DER WISSENSCHAFTEN EV

Germany

EU Contribution

€ 352 448,86

AZIENDA OSPEDALIERO-UNIVERSITARIA ANNA MEYER

Italy

EU Contribution

€ 88 800

UNIVERSITE DE LIEGE

Belgium

EU Contribution

€ 12 470,40

Project information

Grant agreement ID: 241879

Status

Closed project

  • Start date

    1 January 2010

  • End date

    30 June 2015

Funded under:

FP7-HEALTH

  • Overall budget:

    € 15 472 075,44

  • EU contribution

    € 11 935 340

Coordinated by:

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE

France