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ORTHOpedic randomized clinical trial with expanded bone marrow MSC and bioceramics versus autograft in long bone nonUNIONs

Objective

Current orthopaedic treatments permit spontaneous bone regeneration to unite and heal 90% bone injuries. Non-union associates pain and disability, often requiring biological enhancement. Regenerative medicine research suggests to the general public that alternative treatments based on advanced therapy medicinal products (ATMP) are already available. However, early clinical trials only explore its potential benefit. Underreported results and absence of early trial confirmation in adequately powered prospective randomized clinical trials (RCT) indicate that evidence is not available to transfer any technique into routine clinical application.
This ORTHOUNION Project was developed from FP7-Project (REBORNE). Its results confirmed 92% bone healing rate (Gómez-Barrena et al, 2016 submitted manuscript) with an autologous ATMP of GMP expanded bone marrow derived human MSC in non-unions, where the reported bone healing rate after surgery with standard bone autograft is 74%. Any further development requires adequately powered prospective RCTs. This will be the main aim of ORTHOUNION: to assess clinically relevant efficacy of an autologous ATMP with GMP multicentric production in a well-designed, randomized, controlled, three-arm clinical trial under GCP, versus bone autograft, gold-standard in fracture non-unions. A non-inferiority analysis will evaluate if cell dose can be lowered. ATMP has been authorized by the National Competent Authorities of the participating countries in 3 previous trials (REBORNE) and will be monitored by ECRIN-ERIC to ensure quality and credibility of RCT results.
Secondary aims include innovative strategies to increase manufacturing capacity and lower costs to pave translation into routine clinical treatments, biomaterial refinement to facilitate surgery, personalized medicine supportive instruments for patient selection and monitoring, and health economic evaluation. Results in this project may help define the future of bone regenerative medicin

Call for proposal

H2020-SC1-2016-2017

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Sub call

H2020-SC1-2016-RTD

Coordinator

UNIVERSIDAD AUTONOMA DE MADRID
Net EU contribution
€ 824 210,01
Address
Calle Einstein 3 Ciudad Univ Cantoblanco Rectorado
28049 Madrid
Spain

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Region
Comunidad de Madrid Comunidad de Madrid Madrid
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00

Participants (16)

SERVICIO MADRILENO DE SALUD
Spain
Net EU contribution
€ 661 552,11
Address
Plaza Carlos Trias Bertran 7
28020 Madrid

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Region
Comunidad de Madrid Comunidad de Madrid Madrid
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 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.

FUNDACION PARA LA INVESTIGACION BIOMEDICA DEL HOSPITAL UNIVERSITARIO PUERTA DE HIERRO-MAJADAHONDA
Spain
Net EU contribution
€ 612 416,46
Address
Joaquin Rodrigo 2
28222 Majadahonda

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Region
Comunidad de Madrid Comunidad de Madrid Madrid
Activity type
Research Organisations
Non-EU contribution
€ 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.

FUNDACION PARA LA INVESTIGACION BIOMEDICA DEL HOSPITAL UNIVERSIATRIO LA PAZ
Spain
Net EU contribution
€ 78 087,43
Address
Paseo De La Castellana 261
28046 Madrid

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Region
Comunidad de Madrid Comunidad de Madrid Madrid
Activity type
Other
Non-EU contribution
€ 0,00
ETABLISSEMENT FRANCAIS DU SANG
France
Net EU contribution
€ 394 743,25
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)
Non-EU contribution
€ 0,00
UNIVERSITAET ULM
Germany
Net EU contribution
€ 998 476,63
Address
Helmholtzstrasse 16
89081 Ulm

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Region
Baden-Württemberg Tübingen Ulm, Stadtkreis
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
Net EU contribution
€ 221 230,00
Address
Rue De Tolbiac 101
75654 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Non-EU contribution
€ 0,00
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
Net EU contribution
€ 285 956,50
Address
5 Rue Watt
75013 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Non-EU contribution
€ 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.

HEINRICH-HEINE-UNIVERSITAET DUESSELDORF

Participation ended

Germany
Net EU contribution
€ 0,00
Address
Universitaetsstrasse 1
40225 Dusseldorf

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Region
Nordrhein-Westfalen Düsseldorf Düsseldorf, Kreisfreie Stadt
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 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.

FUNDACIO CLINIC PER A LA RECERCA BIOMEDICA
Spain
Net EU contribution
€ 190 450,00
Address
Carrer Rossello 149
08036 Barcelona

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Region
Este Cataluña Barcelona
Activity type
Research Organisations
Non-EU contribution
€ 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.

UNIVERSITAETSKLINIKUM FREIBURG
Germany
Net EU contribution
€ 97 287,50
Address
Hugstetter Strasse 49
79106 Freiburg

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Region
Baden-Württemberg Freiburg Freiburg im Breisgau, Stadtkreis
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE DE TOURS
France
Net EU contribution
€ 193 125,00
Address
Boulevard Tonelle 2
37044 Tours Cedex 9

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Region
Centre — Val de Loire Centre — Val de Loire Indre-et-Loire
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
ISTITUTO ORTOPEDICO RIZZOLI
Italy
Net EU contribution
€ 402 117,35
Address
Via Di Barbiano 1/10
40136 Bologna

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Region
Nord-Est Emilia-Romagna Bologna
Activity type
Research Organisations
Non-EU contribution
€ 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.

ALMA MATER STUDIORUM - UNIVERSITA DI BOLOGNA
Italy
Net EU contribution
€ 47 806,13
Address
Via Zamboni 33
40126 Bologna

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Region
Nord-Est Emilia-Romagna Bologna
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
UNIVERSITA DEGLI STUDI DI MODENA E REGGIO EMILIA
Italy
Net EU contribution
€ 293 680,00
Address
Via Universita 4
41121 Modena

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Region
Nord-Est Emilia-Romagna Modena
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
FONDAZIONE IRCCS CA' GRANDA - OSPEDALE MAGGIORE POLICLINICO
Italy
Net EU contribution
€ 420 950,00
Address
Via Francesco Sforza 28
20122 Milano

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Region
Nord-Ovest Lombardia Milano
Activity type
Other
Non-EU contribution
€ 0,00
BIOMATLANTE
France
Net EU contribution
€ 277 062,50
Address
5 Rue Edouard Belin - Za Des Iv Nations
44360 Vigneux De Bretagne

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Pays de la Loire Pays de la Loire Loire-Atlantique
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00