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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

Field of science

  • /medical and health sciences/clinical medicine/surgery
  • /medical and health sciences/basic medicine/pharmacology and pharmacy/pharmaceutical drug

Call for proposal

H2020-SC1-2016-RTD
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Funding Scheme

RIA - Research and Innovation action

Coordinator

UNIVERSIDAD AUTONOMA DE MADRID
Address
Calle Einstein 3 Ciudad Univ Cantoblanco Rectorado
28049 Madrid
Spain
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 824 210,01

Participants (10)

SERVICIO MADRILENO DE SALUD
Spain
EU contribution
€ 1 352 056
Address
Plaza Carlos Trias Bertran 7
28020 Madrid
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
ETABLISSEMENT FRANCAIS DU SANG
France
EU contribution
€ 394 743,25
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)
UNIVERSITAET ULM
Germany
EU contribution
€ 998 476,63
Address
Helmholtzstrasse 16
89081 Ulm
Activity type
Higher or Secondary Education Establishments
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
EU contribution
€ 221 230
Address
Rue De Tolbiac 101
75654 Paris
Activity type
Research Organisations
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
EU contribution
€ 573 694
Address
5 Rue Watt
75013 Paris
Activity type
Research Organisations
CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE DE TOURS
France
EU contribution
€ 193 125
Address
Boulevard Tonelle 2
37044 Tours Cedex 9
Activity type
Higher or Secondary Education Establishments
ISTITUTO ORTOPEDICO RIZZOLI
Italy
EU contribution
€ 449 923,48
Address
Via Di Barbiano 1/10
40136 Bologna
Activity type
Research Organisations
UNIVERSITA DEGLI STUDI DI MODENA E REGGIO EMILIA
Italy
EU contribution
€ 293 680
Address
Via Universita 4
41121 Modena
Activity type
Higher or Secondary Education Establishments
FONDAZIONE IRCCS CA' GRANDA - OSPEDALE MAGGIORE POLICLINICO
Italy
EU contribution
€ 420 950
Address
Via Francesco Sforza 28
20122 Milano
Activity type
Other
BIOMATLANTE
France
EU contribution
€ 277 062,50
Address
5 Rue Edouard Belin - Za Des Iv Nations
44360 Vigneux De Bretagne
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)