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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.

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

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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