Opendata, web and dolomites

ORTHOUNION SIGNED

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

Total Cost €

0

EC-Contrib. €

0

Partnership

0

Views

0

 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.

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

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

Are you the coordinator (or a participant) of this project? Plaese send me more information about the "ORTHOUNION" project.

For instance: the website url (it has not provided by EU-opendata yet), the logo, a more detailed description of the project (in plain text as a rtf file or a word file), some pictures (as picture files, not embedded into any word file), twitter account, linkedin page, etc.

Send me an  email (fabio@fabiodisconzi.com) and I put them in your project's page as son as possible.

Thanks. And then put a link of this page into your project's website.

The information about "ORTHOUNION" are provided by the European Opendata Portal: CORDIS opendata.

More projects from the same programme (H2020-EU.3.1.3.)

HEADSpAcE (2019)

Translational studies of HEAD and neck cancer in South America and Europe

Read More  

TT4CL (2019)

Clinical development of oral oleylphosphocholine as a new drug for the treatment of Old World Cutaneous Leishmaniasis

Read More  

INTE-AFRICA (2019)

Integrating and decentralising diabetes and hypertension services in Africa

Read More