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.

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

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  

INTE-AFRICA (2019)

Integrating and decentralising diabetes and hypertension services in Africa

Read More