EEfficacy of intradiscal injection of allogeneic mesenchymal stem cells from bone marrow in subjects with low back pain caused by degenerative intervertebral disc disease unresponsive to conventional therapy
Project objectives
Low back pain is most often caused by a degenerative pathology of the lumbar discs. The medical therapies available today are successful in temporarily relieving the pain however sometimes the pain in the lower back becomes chronic. No therapy today can restore intervertebral disc function or provide long-term relief from degenerative lumbar disc disease. Bone marrow allogeneic mesenchymal cells are cells capable of renewal and differentiation. These cells are defined as allogeneic in nature as they derive from healthy donors after careful evaluation.
Scientific studies have shown that these cells have anti-inflammatory properties, but only a high-quality, randomized controlled trial can determine whether it is a truly effective alternative to spine fusion or disc replacement. In this clinical trial, a new treatment method will be applied, previously used for the treatment of low back pain caused by early degenerative lumbar disc disease. Where, mesenchymal stem cells are isolated from the donor bone marrow. Sufficient cells can be obtained by culturing them for several days, freezing them and revitalizing them for injection to patients. These cells will then be injected into the damaged disk under local anesthesia.
Results from a previous clinical trial indicate a rapid and progressive improvement in function indices of 65% to 78% over 1 year after intervertebral administration of allogeneic mesenchymal cells. Additionally, the procedure appeared to be safe and no side effects were reported.
The aim of the project is to evaluate the efficacy of intradiscal injection of allogeneic bone marrow-extracted mesenchymal stem cells (BM-MSCs) for the treatment of low back pain using the visual analogue scale (VAS) and functional status (Oswestry Disability Index - ODI) 12 months after treatment, defined as responsive if there was an improvement in the VAS scale for pain of at least 20% and 15 mm between baseline and month 12, or with an improvement in the ODI of 20% between baseline and month 12.
Respine is a multicenter, prospective, randomized, controlled, double-blind Phase 2/3 efficacy study comparing adult and control allogeneic bone marrow mesenchymal stem cell therapy in subjects with chronic (>3 months) low back pain caused by lumbar degenerative disc disease unresponsive to conventional therapy. Patients will be randomized into 2 arms of 56 patients and regularly followed up for 24 months.
Start and end date
2017 - 2021
Project managers
Dr. Gianluca Vadalà - Coordinator
Prof. Rocco Papalia
Prof. Vincenzo Denaro
Coordinating institution of the project
Center Hospitalier Universitaire Montpellier (France)
Other Institutions involved in the project
Campus Bio Medico University of Rome (Italy)
University of Navarre (Spain)
University of Valladolid (Spain)
Univercell Biosolutions Sas (France)
National University Of Ireland, Galway (Ireland)
Citospin SL (Spain)
Institut De Terapia Regenerative Tissular Sl (Spain)
Assistance Public - Hopitaux De Paris (France)
Center Hospitalier Universitaire De Nantes (France)
Center National De La Recherche Scientifique (France)
Ecrin European Clinical Research Infrastructure Network (France)
Verein Fur Berufsgenossenschaftliche Heilbehandlung Halle Ev (Germany)
Funding source
European Commission Horizon 2020