Record #204246 - GSI Repository

RESPINE

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

Coordinator	Centre Hospitalier Universitaire de Rennes ; Citospin (Spain) ; Assistance Publique -Hopitaux De Paris ; CENTRE HOSPITALIER UNIVERSITAIRE MONTPELLIER ; Univercell-Biosolutions (France) ; Università Campus Bio-Medico ; University of Navarra ; National University of Ireland Galway ; ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK ; University of Valladolid ; INSTITUT DE TERAPIA REGENERATIVA TISULAR SL ; BG Klinikum Bergmannstrost Halle ; Université de Montpellier ; Centre Hospitalier Universitaire de Nantes ; CNRS - Institut des Sciences Biologiques
Grant period	2017-01-01 - 2023-06-30
Funding body	European Union
Call number	H2020-SC1-2016-RTD
Grant number	732163
Identifier	G:(EU-Grant)732163

Note: 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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Record created 2017-06-14, last modified 2023-08-27

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