Opendata, web and dolomites

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 €

0

EC-Contrib. €

0

Partnership

0

Views

0

 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.

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

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

Are you the coordinator (or a participant) of this project? Plaese send me more information about the "RESPINE" 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 "RESPINE" are provided by the European Opendata Portal: CORDIS opendata.

More projects from the same programme (H2020-EU.3.1.3.)

PanCareFollowUp (2019)

PanCareFollowUp: Novel, patient-centred survivorship care to improve care quality, effectiveness, cost-effectiveness and accessibility for survivors and caregivers

Read More  

GACD (2019)

Global Alliance for Chronic Diseases Secretariat

Read More  

LEGACy (2019)

CeLac and European consortium for a personalized medicine approach to Gastric Cancer

Read More