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.

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

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.)

TT4CL (2019)

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

Read More  

PREFERABLE (2019)

Project on Exercise for Fatigue Eradication in Advanced Breast cancer to improve quality of life

Read More  

FAIR (2020)

FLAGELLIN AEROSOL THERAPY AS AN IMMUNOMODULATORY ADJUNCT TO THE ANTIBIOTIC TREATMENT OF DRUG-RESISTANT BACTERIAL PNEUMONIA

Read More