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ORTHOUNION SIGNED

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

Total Cost €

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EC-Contrib. €

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Partnership

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 ORTHOUNION project word cloud

Explore the words cloud of the ORTHOUNION project. It provides you a very rough idea of what is the project "ORTHOUNION" about.

heal    unions    barrena    disability    trials    national    al    patient    spontaneous    technique    regeneration    capacity    msc    injuries    underreported    92    expanded    human    supportive    quality    innovative    reborne    confirmed    therapy    designed    et    competent    secondary    eric    medicinal    transfer    treatments    associates    gcp    manufacturing    clinical    ecrin    cell    authorized    standard    gmp    randomized    fracture    absence    pain    74    fp7    confirmation    clinically    monitored    current    reported    economic    mez    health    pave    versus    union    alternative    2016    monitoring    surgery    indicate    90    public    efficacy    participating    arm    translation    routine    multicentric    dose    adequately    lower    explore    rate    oacute    atmp    lowered    countries    regenerative    orthopaedic    bone    submitted    biological    rcts    autologous    gold    rct    requiring    enhancement    medicin    credibility    powered    trial    medicine    suggests    personalized    benefit    evaluation    unite    refinement    prospective    permit    marrow    manuscript    inferiority    strategies    instruments    autograft    healing    orthounion    biomaterial   

Project "ORTHOUNION" data sheet

The following table provides information about the project.

Coordinator
UNIVERSIDAD AUTONOMA DE MADRID 

Organization address
address: CALLE EINSTEIN 3 CIUDAD UNIV CANTOBLANCO RECTORADO
city: MADRID
postcode: 28049
website: http://www.uam.es

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Spain [ES]
 Project website https://orthounion.eu/
 Total cost 5˙999˙150 €
 EC max contribution 5˙999˙150 € (100%)
 Programme 1. H2020-EU.3.1.3. (Treating and managing disease)
 Code Call H2020-SC1-2016-RTD
 Funding Scheme RIA
 Starting year 2017
 Duration (year-month-day) from 2017-01-01   to  2021-12-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
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

Map

 Project 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

 Deliverables

List of deliverables.
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.

 Publications

year authors and title journal last update
List of publications.
2018 Enrique Gómez-Barrena, Norma G. Padilla-Eguiluz, Cristina Avendaño-Solá, Concepción Payares-Herrera, Ana Velasco-Iglesias, Ferran Torres, Philippe Rosset, Florian Gebhard, Nicola Baldini, Juan C. Rubio-Suarez, Eduardo García-Rey, José Cordero-Ampuero, Javier Vaquero-Martin, Francisco Chana, Fernando Marco, Javier García-Coiradas, Pedro Caba-Dessoux, Pablo de la Cuadra, Philippe Hernigou, Charles-Henri Flouzat-Lachaniette, François Gouin, Didier Mainard, Jean Michel Laffosse, Miriam Kalbitz, Ingo Marzi, Norbert Südkamp, Ulrich Stöckle, 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
2017 Mariele Viganò, 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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