Explore the words cloud of the ORTHOUNION project. It provides you a very rough idea of what is the project "ORTHOUNION" about.
The following table provides information about the project.
UNIVERSIDAD AUTONOMA DE MADRID
|Coordinator Country||Spain [ES]|
|Total cost||5˙999˙150 €|
|EC max contribution||5˙999˙150 € (100%)|
1. H2020-EU.3.1.3. (Treating and managing disease)
|Duration (year-month-day)||from 2017-01-01 to 2021-12-31|
Take a look of project's partnership.
|1||UNIVERSIDAD AUTONOMA DE MADRID||ES (MADRID)||coordinator||824˙210.00|
|2||SERVICIO MADRILENO DE SALUD||ES (MADRID)||participant||1˙352˙056.00|
|3||UNIVERSITAET ULM||DE (ULM)||participant||998˙476.00|
|4||ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK||FR (PARIS)||participant||573˙694.00|
|5||ISTITUTO ORTOPEDICO RIZZOLI||IT (BOLOGNA)||participant||449˙923.00|
|6||FONDAZIONE IRCCS CA' GRANDA - OSPEDALE MAGGIORE POLICLINICO||IT (MILANO)||participant||420˙950.00|
|7||ETABLISSEMENT FRANCAIS DU SANG||FR (LA PLAINE SAINT DENIS)||participant||394˙743.00|
|8||UNIVERSITA DEGLI STUDI DI MODENA E REGGIO EMILIA||IT (MODENA)||participant||293˙680.00|
|9||BIOMATLANTE||FR (VIGNEUX DE BRETAGNE)||participant||277˙062.00|
|10||INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE||FR (PARIS)||participant||221˙230.00|
|11||CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE DE TOURS||FR (TOURS CEDEX 9)||participant||193˙125.00|
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
|Creation of a website||Websites, patent fillings, videos etc.||2020-02-25 15:01:21|
|Implement ORTHOUNION project on the dedicated website and establish a secured collaborative platform||Other||2020-02-25 15:01:21|
Take a look to the deliverables list in detail: detailed list of ORTHOUNION deliverables.
|year||authors and title||journal||last update|
Enrique GÃ³mez-Barrena, Norma G. Padilla-Eguiluz, Cristina AvendaÃ±o-SolÃ¡, ConcepciÃ³n Payares-Herrera, Ana Velasco-Iglesias, Ferran Torres, Philippe Rosset, Florian Gebhard, Nicola Baldini, Juan C. Rubio-Suarez, Eduardo GarcÃa-Rey, JosÃ© Cordero-Ampuero, Javier Vaquero-Martin, Francisco Chana, Fernando Marco, Javier GarcÃa-Coiradas, Pedro Caba-Dessoux, Pablo de la Cuadra, Philippe Hernigou, Charles-Henri Flouzat-Lachaniette, FranÃ§ois Gouin, Didier Mainard, Jean Michel Laffosse, Miriam Kalbitz, Ingo Marzi, Norbert SÃ¼dkamp, Ulrich StÃ¶ckle, Gabriela Ciapetti, Davide Maria Donati, Luigi Zagra, Ugo Pazzaglia, Guido Zarattini, Rodolfo Capanna, Fabio Catani
A Multicentric, Open-Label, Randomized, Comparative Clinical Trial of Two Different Doses of Expanded hBM-MSCs Plus Biomaterial versus Iliac Crest Autograft, for Bone Healing in Nonunions after Long Bone Fractures: Study Protocol
published pages: 1-13, ISSN: 1687-966X, DOI: 10.1155/2018/6025918
|Stem Cells International 2018||2020-02-25|
Mariele ViganÃ², Rosaria Giordano, Lorenza Lazzari
Challenges of running a GMP facility for regenerative medicine in a public hospital
published pages: 803-813, ISSN: 1746-0751, DOI: 10.2217/rme-2017-0051
|Regenerative Medicine 12/7||2020-02-25|
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The information about "ORTHOUNION" are provided by the European Opendata Portal: CORDIS opendata.
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