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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.

Call for proposal

H2020-SC1-2016-RTD
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Coordinator

CENTRE HOSPITALIER UNIVERSITAIRE MONTPELLIER
Address
Avenue Du Doyen Gaston Giraud 191
34000 Montpellier
France
Activity type
Research Organisations
EU contribution
€ 885 541,33

Participants (14)

UNIVERSIDAD DE NAVARRA
Spain
EU contribution
€ 335 500
Address
Campus Universitario Edificio Central
31080 Pamplona
Activity type
Higher or Secondary Education Establishments
UNIVERSIDAD DE VALLADOLID
Spain
EU contribution
€ 402 537,99
Address
Plaza Santa Cruz 8 Palacio De Santa Cruz
47002 Valladolid
Activity type
Higher or Secondary Education Establishments
HUMAN CELL DESIGN
France
EU contribution
€ 233 716,63
Address
Place Pierre Potier Centre Pierre Potier Canceropole Entree B 1
31000 Toulouse
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
NATIONAL UNIVERSITY OF IRELAND GALWAY
Ireland
EU contribution
€ 258 745,94
Address
University Road
H91 Galway
Activity type
Higher or Secondary Education Establishments
CITOSPIN S.L.
Spain
EU contribution
€ 964 126,63
Address
Paseo De Belen 11 Edificio I+d Campus Miguel Delib Fpcuva Unidad De Produccion Celular
47011 Valladolid
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
INSTITUT DE TERAPIA REGENERATIVA TISULAR SL
Spain
EU contribution
€ 342 237,85
Address
Calle Vilana 12
08022 Barcelona
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
EU contribution
€ 478 250
Address
3 Avenue Victoria
75000 Paris
Activity type
Research Organisations
CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES
France
EU contribution
€ 325 353
Address
Allee De L'ile Gloriette 5
44093 Nantes
Activity type
Higher or Secondary Education Establishments
CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE CNRS
France
EU contribution
€ 220 306,25
Address
Rue Michel Ange 3
75794 Paris
Activity type
Other
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
EU contribution
€ 195 325
Address
5 Rue Watt
75013 Paris
Activity type
Research Organisations
BG KLINIKUM BERGMANNSTROST HALLE GGMBH
Germany
EU contribution
€ 217 766,25
Address
Merseburger Strasse 165
06112 Halle
Activity type
Other
UNIVERSITA CAMPUS BIO MEDICO DI ROMA
Italy
EU contribution
€ 351 250
Address
Via Alvaro Del Portillo 21
00128 Roma
Activity type
Higher or Secondary Education Establishments
UNIVERSITE DE MONTPELLIER
France
EU contribution
€ 249 500
Address
163 Rue Auguste Broussonnet
34090 Montpellier
Activity type
Higher or Secondary Education Establishments
CENTRE HOSPITALIER UNIVERSITAIRE DE RENNES
France
EU contribution
€ 95 679,38
Address
Rue Henri Le Guilloux -Hopital 2
35033 Rennes Cedex 9
Activity type
Higher or Secondary Education Establishments