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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.

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

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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