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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 €

EC-Contrib. €

Partnership

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Outcomes and
results

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 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.	FR (MONTPELLIER)	coordinator	837˙963.00
2	CITOSPIN S.L. CITOSPIN S.L. Organization address address: PASEO DE BELEN 11 EDIFICIO I+D CAMPUS MIGUEL DELIB FPCUVA UNIDAD DE PRODUCCION CELULAR city: VALLADOLID postcode: 47011 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (VALLADOLID)	participant	964˙126.00
3	ASSISTANCE PUBLIQUE HOPITAUX DE PARIS ASSISTANCE PUBLIQUE HOPITAUX DE PARIS Organization address address: 3 AVENUE VICTORIA city: PARIS postcode: 75000 website: http://www.aphp.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	495˙750.00
4	UNIVERSIDAD DE VALLADOLID UNIVERSIDAD DE VALLADOLID Organization address address: PLAZA SANTA CRUZ 8 PALACIO DE SANTA CRUZ city: VALLADOLID postcode: 47002 website: www.uva.es contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (VALLADOLID)	participant	402˙537.00
5	CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES Organization address address: Allee de l'Ile Gloriette 5 city: NANTES postcode: 44093 website: www.chu-nantes.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (NANTES)	participant	375˙125.00
6	UNIVERSIDAD DE NAVARRA UNIVERSIDAD DE NAVARRA Organization address address: CAMPUS UNIVERSITARIO EDIFICIO CENTRAL city: PAMPLONA postcode: 31080 website: www.unav.es contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (PAMPLONA)	participant	363˙000.00
7	UNIVERSITA CAMPUS BIO MEDICO DI ROMA UNIVERSITA CAMPUS BIO MEDICO DI ROMA Organization address address: VIA ALVARO DEL PORTILLO 21 city: ROMA postcode: 128 website: www.unicampus.it contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (ROMA)	participant	321˙362.00
8	INSTITUT DE TERAPIA REGENERATIVA TISULAR SL INSTITUT DE TERAPIA REGENERATIVA TISULAR SL Organization address address: CALLE VILANA 12 city: BARCELONA postcode: 8022 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (BARCELONA)	participant	300˙860.00
9	BG KLINIKUM BERGMANNSTROST HALLE GGMBH BG KLINIKUM BERGMANNSTROST HALLE GGMBH Organization address address: MERSEBURGER STRASSE 165 city: HALLE postcode: 6112 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (HALLE)	participant	260˙012.00
10	NATIONAL UNIVERSITY OF IRELAND GALWAY NATIONAL UNIVERSITY OF IRELAND GALWAY Organization address address: UNIVERSITY ROAD city: Galway postcode: H91 website: www.nuigalway.ie contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IE (Galway)	participant	258˙745.00
11	UNIVERSITE DE MONTPELLIER UNIVERSITE DE MONTPELLIER Organization address address: 163 RUE AUGUSTE BROUSSONNET city: MONTPELLIER postcode: 34090 website: www.umontpellier.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (MONTPELLIER)	participant	249˙500.00
12	UNIVERCELL BIOSOLUTIONS SAS UNIVERCELL BIOSOLUTIONS SAS Organization address address: PLACE PIERRE POTIER CENTRE PIERRE POTIER CANCEROPOLE ENTREE B city: TOULOUSE postcode: 31000 website: www.univercell-biosolutions.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (TOULOUSE)	participant	233˙716.00
13	CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE CNRS CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE CNRS Organization address address: RUE MICHEL ANGE 3 city: PARIS postcode: 75794 website: www.cnrs.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	220˙306.00
14	ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK Organization address address: 5 RUE WATT city: PARIS postcode: 75013 website: www.ecrin.org contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	177˙150.00
15	CENTRE HOSPITALIER UNIVERSITAIRE DE RENNES CENTRE HOSPITALIER UNIVERSITAIRE DE RENNES Organization address address: RUE HENRI LE GUILLOUX -HOPITAL 2 city: RENNES CEDEX 9 postcode: 35033 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	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

List of publications.
year	authors and title	journal	last update
2019	Abbie. L. A. Binch, Stephen M. Richardson, Judith A. Hoyland, Frank P. Barry Combinatorial conditioning of adipose derivedâ€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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