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
Organization address
address: PLACE PIERRE POTIER CENTRE PIERRE POTIER CANCEROPOLE ENTREE B
city: TOULOUSE
postcode: 31000
website: www.univercell-biosolutions.com
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
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
Are you the coordinator (or a participant) of this project? Plaese send me more information about the "RESPINE" project.
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Send me an email (fabio@fabiodisconzi.com) and I put them in your project's page as son as possible.
Thanks. And then put a link of this page into your project's website.
The information about "RESPINE" are provided by the European Opendata Portal: CORDIS opendata.
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