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RESPINE SIGNED

REgenerative therapy of intervertebral disc: a double blind phase 2b trial of intradiscal injection of mesenchymal stromal cells in degenerative disc disease of the lomber SPINE unresponsive to conventional therapy

Total Cost €

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EC-Contrib. €

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Partnership

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 RESPINE project word cloud

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

accelerated    78    unmet    mechanical    relaxation    clinical    twelve    disc    degeneration    diseases    rapid    regenerative    patients    allogeneic    clinically    t2    intradiscal    efficient    trials    progressive    therapies    strategy    broadly    respine    randomized    disability    allogenic    proven    list    degenerative    cells    trial    sustainably    10k    surgery    transfer    efficacy    2a    treatment    24    function    below    multicentre    adjacent    smes    therapy    112    least    mesenchymal    innovative    segments    thanks    rigorously    functional    clinic    pain    procedure    bm    first    disease    medical    disabling    encouraging    world    marketed    notably    organisation    receive    standardisation    intervertebral    minimally    applicable    health    mri    50    cell    exhibited    invasive    prepared    reduce    safety    injection    65    msc    automation    back    months    stem    demonstrated    immune    biomechanical    indexes    standardised    ddd    chronic    improvement    2b   

Project "RESPINE" data sheet

The following table provides information about the project.

Coordinator
CENTRE HOSPITALIER UNIVERSITAIRE MONTPELLIER 

Organization address
address: AVENUE DU DOYEN GASTON GIRAUD 191
city: MONTPELLIER
postcode: 34000
website: www.chu-montpellier.fr

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 France [FR]
 Project website http://www.chu-montpellier.fr/
 Total cost 5˙555˙836 €
 EC max contribution 5˙555˙836 € (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  2020-12-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    CENTRE HOSPITALIER UNIVERSITAIRE MONTPELLIER FR (MONTPELLIER) coordinator 837˙963.00
2    CITOSPIN S.L. ES (VALLADOLID) participant 964˙126.00
3    ASSISTANCE PUBLIQUE HOPITAUX DE PARIS FR (PARIS) participant 495˙750.00
4    UNIVERSIDAD DE VALLADOLID ES (VALLADOLID) participant 402˙537.00
5    CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES FR (NANTES) participant 375˙125.00
6    UNIVERSIDAD DE NAVARRA ES (PAMPLONA) participant 363˙000.00
7    UNIVERSITA CAMPUS BIO MEDICO DI ROMA IT (ROMA) participant 321˙362.00
8    INSTITUT DE TERAPIA REGENERATIVA TISULAR SL ES (BARCELONA) participant 300˙860.00
9    BG KLINIKUM BERGMANNSTROST HALLE GGMBH DE (HALLE) participant 260˙012.00
10    NATIONAL UNIVERSITY OF IRELAND GALWAY IE (Galway) participant 258˙745.00
11    UNIVERSITE DE MONTPELLIER FR (MONTPELLIER) participant 249˙500.00
12    UNIVERCELL BIOSOLUTIONS SAS FR (TOULOUSE) participant 233˙716.00
13    CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE CNRS FR (PARIS) participant 220˙306.00
14    ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK FR (PARIS) participant 177˙150.00
15    CENTRE HOSPITALIER UNIVERSITAIRE DE RENNES FR (RENNES CEDEX 9) participant 95˙679.00

Map

 Project objective

The World Health Organisation (WHO) has included low back pain in its list of twelve priority diseases. Notably, Degenerative disc disease (DDD) presents a large, unmet medical need which results in a disabling loss of mechanical function. Today, no efficient therapy is available. Chronic cases often receive surgery, which may lead to biomechanical problems and accelerated degeneration of adjacent segments. Our consortium partners have developed and studied stem cell-based, regenerative therapies with encouraging results in phase 1 and 2a trials. Patients exhibited rapid and progressive improvement of functional and pain indexes by 50% within 6 months and by 65% to 78% after 1 year with no side effects. In addition, MRI T2 relaxation measurements demonstrated a significant improvement. To develop the world’s first rigorously proven, effective treatment of DDD, RESPINE aims to assess, via a multicentre, randomized, controlled, phase 2b clinical trial including 112 patients with DDD, the efficacy of an allogenic intervertebral mesenchymal stem cell (MSC)-based therapy. This innovative therapy aims to rapidly (within 3 months) and sustainably (at least 24 months) reduce pain and disability. In addition, the consortium aims to provide new knowledge on immune response & safety associated with allogeneic BM-MSC intradiscal injection. This simple procedure would be cost-effective, minimally invasive, and standardised. The transfer to the clinic will be prepared at a cost below 10k€ thanks to the strategy of production of allogenic cells, automation & EU standardisation. At the end of the RESPINE trial, we aim to propose a broadly available and clinically applicable treatment for DDD, marketed by European SMEs.

 Deliverables

List of deliverables.
Dissemination and Communication Documents, reports 2020-03-23 11:32:02
Registration of clinical trial on EudraCT and Clinicaltrials.gov Documents, reports 2020-03-23 11:32:02

Take a look to the deliverables list in detail:  detailed list of RESPINE deliverables.

 Publications

year authors and title journal last update
List of publications.
2019 Abbie. L. A. Binch, Stephen M. Richardson, Judith A. Hoyland, Frank P. Barry
Combinatorial conditioning of adipose derived‐mesenchymal stem cells enhances their neurovascular potential: Implications for intervertebral disc degeneration
published pages: , ISSN: 2572-1143, DOI: 10.1002/jsp2.1072
JOR SPINE 2/4 2020-03-23

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

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