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 Fields of science medical and health sciencesclinical medicinesurgerymedical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsnatural scienceschemical sciencesinorganic chemistryalkaline earth metalsmedical and health scienceshealth sciencespersonalized medicineengineering and technologyindustrial biotechnologybiomaterials Keywords Bone regeneration expanded Bone Marrow derived MSCs regulatory approved IMP long bone fracture non-union avascular necrosis of the femoral head multicentric comparative clinical trials Programme(s) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.3. - Treating and managing disease Topic(s) SC1-PM-11-2016-2017 - Clinical research on regenerative medicine Call for proposal H2020-SC1-2016-2017 See other projects for this call Sub call H2020-SC1-2016-RTD Funding Scheme RIA - Research and Innovation action Coordinator UNIVERSIDAD AUTONOMA DE MADRID Net EU contribution € 824 210,01 Address Calle einstein 3 ciudad univ cantoblanco rectorado 28049 Madrid Spain See on map Region Comunidad de Madrid Comunidad de Madrid Madrid Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 Participants (16) Sort alphabetically Sort by Net EU contribution Expand all Collapse all SERVICIO MADRILENO DE SALUD Spain Net EU contribution € 661 552,11 Address Plaza carlos trias bertran 7 28020 Madrid See on map Region Comunidad de Madrid Comunidad de Madrid Madrid Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window 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. 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 See on map Region Comunidad de Madrid Comunidad de Madrid Madrid Activity type Research Organisations Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window 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. 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 See on map Region Comunidad de Madrid Comunidad de Madrid Madrid Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 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 See on map Region Ile-de-France Ile-de-France Seine-Saint-Denis Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 UNIVERSITAET ULM Germany Net EU contribution € 998 476,63 Address Helmholtzstrasse 16 89081 Ulm See on map Region Baden-Württemberg Tübingen Ulm, Stadtkreis Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 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 See on map Region Ile-de-France Ile-de-France Paris Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK France Net EU contribution € 285 956,50 Address 30 bd saint-jacques batiment b 75014 Paris See on map Region Ile-de-France Ile-de-France Paris Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window 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. HEINRICH-HEINE-UNIVERSITAET DUESSELDORF Participation ended Germany Net EU contribution € 0,00 Address Universitaetsstrasse 1 40225 Dusseldorf See on map Region Nordrhein-Westfalen Düsseldorf Düsseldorf, Kreisfreie Stadt Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window 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. FUNDACIO DE RECERCA CLINIC BARCELONA-INSTITUT D INVESTIGACIONS BIOMEDIQUES AUGUST PI I SUNYER Spain Net EU contribution € 190 450,00 Address Carrer rossello 149 08036 Barcelona See on map Region Este Cataluña Barcelona Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window 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. UNIVERSITAETSKLINIKUM FREIBURG Germany Net EU contribution € 97 287,50 Address Hugstetter strasse 49 79106 Freiburg See on map Region Baden-Württemberg Freiburg Freiburg im Breisgau, Stadtkreis Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE DE TOURS France Net EU contribution € 193 125,00 Address Boulevard tonelle 2 37044 Tours cedex 9 See on map Region Centre — Val de Loire Centre — Val de Loire Indre-et-Loire Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 ISTITUTO ORTOPEDICO RIZZOLI Italy Net EU contribution € 402 117,35 Address Via di barbiano 1/10 40136 Bologna See on map Region Nord-Est Emilia-Romagna Bologna Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window 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. ALMA MATER STUDIORUM - UNIVERSITA DI BOLOGNA Italy Net EU contribution € 47 806,13 Address Via zamboni 33 40126 Bologna See on map Region Nord-Est Emilia-Romagna Bologna Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 UNIVERSITA DEGLI STUDI DI MODENA E REGGIO EMILIA Italy Net EU contribution € 293 680,00 Address Via universita 4 41121 Modena See on map Region Nord-Est Emilia-Romagna Modena Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 FONDAZIONE IRCCS CA' GRANDA - OSPEDALE MAGGIORE POLICLINICO Italy Net EU contribution € 420 950,00 Address Via francesco sforza 28 20122 Milano See on map Region Nord-Ovest Lombardia Milano Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 BIOMATLANTE France Net EU contribution € 277 062,50 Address 5 rue edouard belin - za des iv nations 44360 Vigneux de bretagne See on map 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) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00
