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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. €

0

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.

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

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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