RESPINE

RESPINE

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Abstract

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 allogeneic 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 EUROSPINE trial, we aim to propose a broadly available and clinically applicable treatment for DDD, marketed by European SMEs.

Consortium

Centre Hospitalier Universitaire Montpellier (Coordinator), Universidad De Navarra, Universidad De Valladolid, Univercell Biosolutions SAS, NUI Galway, Citospin S.L., Institut De Terapia Regenerativa Tisular SL, Assistance Publique - Hopitaux De Paris, CNRS, ECRIN, Bg Klinikum Bergmannstrost Halle GGMBH, Universita Campus Bio Medico Di Roma, Universite De Montpellier, Centre Hospitalier Universitaire De Rennes.

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