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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

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.
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Coordinator

CENTRE HOSPITALIER UNIVERSITAIRE MONTPELLIER

Address

Avenue Du Doyen Gaston Giraud 191
34000 Montpellier

France

Activity type

Other

EU Contribution

€ 837 963,43

Participants (14)

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UNIVERSIDAD DE NAVARRA

Spain

EU Contribution

€ 363 000

UNIVERSIDAD DE VALLADOLID

Spain

EU Contribution

€ 402 537,99

UNIVERCELL BIOSOLUTIONS SAS

France

EU Contribution

€ 233 716,63

NATIONAL UNIVERSITY OF IRELAND GALWAY

Ireland

EU Contribution

€ 258 745,94

CITOSPIN S.L.

Spain

EU Contribution

€ 964 126,63

INSTITUT DE TERAPIA REGENERATIVA TISULAR SL

Spain

EU Contribution

€ 300 860

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

France

EU Contribution

€ 495 750

CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES

France

EU Contribution

€ 375 125

CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE CNRS

France

EU Contribution

€ 220 306,25

ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK

France

EU Contribution

€ 177 150

BG KLINIKUM BERGMANNSTROST HALLE GGMBH

Germany

EU Contribution

€ 260 012,50

UNIVERSITA CAMPUS BIO MEDICO DI ROMA

Italy

EU Contribution

€ 321 362,50

UNIVERSITE DE MONTPELLIER

France

EU Contribution

€ 249 500

CENTRE HOSPITALIER UNIVERSITAIRE DE RENNES

France

EU Contribution

€ 95 679,38

Project information

Grant agreement ID: 732163

Status

Ongoing project

  • Start date

    1 January 2017

  • End date

    31 December 2020

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 5 555 836,25

  • EU contribution

    € 5 555 836,25

Coordinated by:

CENTRE HOSPITALIER UNIVERSITAIRE MONTPELLIER

France