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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-SC1-2016-2017

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Sub call

H2020-SC1-2016-RTD

Coordinator

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

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Region
Occitanie Languedoc-Roussillon Hérault
Activity type
Research Organisations
Non-EU contribution
€ 0,00

Participants (17)

UNIVERSIDAD DE NAVARRA
Spain
Net EU contribution
€ 335 500,00
Address
Campus Universitario Edificio Central
31080 Pamplona

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Region
Noreste Comunidad Foral de Navarra Navarra
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
UNIVERSIDAD DE VALLADOLID
Spain
Net EU contribution
€ 402 537,99
Address
Plaza Santa Cruz 8 Palacio De Santa Cruz
47002 Valladolid

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Region
Castilla y León Valladolid
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
HUMAN CELL DESIGN
France
Net EU contribution
€ 233 716,63
Address
Place Pierre Potier Centre Pierre Potier Canceropole Entree B 1
31000 Toulouse

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Occitanie Midi-Pyrénées Haute-Garonne
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
NATIONAL UNIVERSITY OF IRELAND GALWAY
Ireland
Net EU contribution
€ 258 745,94
Address
University Road
H91 Galway

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Region
Ireland Eastern and Midland Dublin
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
CITOSPIN S.L.
Spain
Net EU contribution
€ 964 126,63
Address
Paseo De Belen 11 Edificio I+d Campus Miguel Delib Fpcuva Unidad De Produccion Celular
47011 Valladolid

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Castilla y León Valladolid
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
INSTITUT DE TERAPIA REGENERATIVA TISULAR SL
Spain
Net EU contribution
€ 342 237,85
Address
Calle Vilana 12
08022 Barcelona

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Este Cataluña Barcelona
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
Net EU contribution
€ 478 250,00
Address
3 Avenue Victoria
75000 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Non-EU contribution
€ 0,00
CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES
France
Net EU contribution
€ 325 353,00
Address
Allee De L'ile Gloriette 5
44093 Nantes

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Region
Pays de la Loire Pays de la Loire Loire-Atlantique
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE CNRS
France
Net EU contribution
€ 197 192,50
Address
Rue Michel Ange 3
75794 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

UNIVERSITE PAUL SABATIER TOULOUSE III
France
Net EU contribution
€ 23 113,75
Address
Route De Narbonne 118
31062 Toulouse Cedex 9

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Region
Occitanie Midi-Pyrénées Haute-Garonne
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
Net EU contribution
€ 195 325,00
Address
5 Rue Watt
75013 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

HEINRICH-HEINE-UNIVERSITAET DUESSELDORF

Participation ended

Germany
Net EU contribution
€ 0,00
Address
Universitaetsstrasse 1
40225 Dusseldorf

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Region
Nordrhein-Westfalen Düsseldorf Düsseldorf, Kreisfreie Stadt
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
BG KLINIKUM BERGMANNSTROST HALLE GGMBH
Germany
Net EU contribution
€ 217 766,25
Address
Merseburger Strasse 165
06112 Halle

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Region
Sachsen-Anhalt Sachsen-Anhalt Halle (Saale), Kreisfreie Stadt
Activity type
Other
Non-EU contribution
€ 0,00
UNIVERSITA CAMPUS BIO MEDICO DI ROMA
Italy
Net EU contribution
€ 351 250,00
Address
Via Alvaro Del Portillo 21
00128 Roma

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Region
Centro (IT) Lazio Roma
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
UNIVERSITE DE MONTPELLIER
France
Net EU contribution
€ 230 000,00
Address
163 Rue Auguste Broussonnet
34090 Montpellier

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Region
Occitanie Languedoc-Roussillon Hérault
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
Net EU contribution
€ 19 500,00
Address
Rue De Tolbiac 101
75654 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Non-EU contribution
€ 0,00
CENTRE HOSPITALIER UNIVERSITAIRE DE RENNES
France
Net EU contribution
€ 95 679,38
Address
Rue Henri Le Guilloux -Hopital 2
35033 Rennes Cedex 9

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Region
Bretagne Bretagne Ille-et-Vilaine
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00