Efficacy of Intradiscal Injection of BM-MSC in Subjects With Chronic Low Back Pain (LBP) Due to Lumbar Degenerative Disc Disease (DDD) Unresponsive

This will be a multicenter, prospective, double blind, randomized phase 2/3 trial comparing culture-expanded allogeneic adult BM-MSCs with sham-treated controls. This trial will evaluate the efficacy of intradiscal injection of BM-MSCs in chronic low back pain due to lumbar degenerative disc disease (DDD) unresponsive to conventional therapy . Visual analog scale (VAS) and functional status (by Oswestry Disability Index - ODI) will be evaluated 12 months after treatment, defining responders in case of improvement of VAS for pain of at least 20% and 20 mm between baseline and month 12, or improvement of ODI of 20% between baseline and month 12.

NCT Number	NCT03737461
Lead Sponsor	University Hospital, Montpellier Collaborators: Interdisziplinäres Zentrum Klinische Studien (IZKS), European Clinical Research Infrastructure Network, Département de l'information médicale, CHU de Montpellier, Centre National de la Recherche Scientifique, France, Université Montpellier, Univercell-Biosolutions S.A.S, National University of Ireland, Galway, Ireland, University of Valladolid, Citospin, Rennes University Hospital, APHP, Campus Bio-Medico University, BG Klinikum Bergmannstrost, Halle, Germany, Nantes University Hospital, Institut de Terapia Regenerativa Tissular, University of Navarra
Conditions	Recurrent Low Back Pain, Degenerative Disc Disease (DDD)
Enrollment	113 participants
Start Date	2019-02-18
Primary Completion	2022-05-30 (estimated)
Study Completion	2026-03-08 (estimated)
Updated on ClinicalTrials.gov	2025-09-30