Overview

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

Status:
Recruiting

Trial end date:
2022-12-01

Target enrollment:

Participant gender:

Summary

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.

Phase:

Phase 2/Phase 3

Details

Lead Sponsor:

University Hospital, Montpellier

Collaborators:

APHP
BG Klinikum Bergmannstrost, Halle, Germany
Campus Bio-Medico University
Centre National de la Recherche Scientifique, France
Citospin
Département de l'information médicale, CHU de Montpellier
Département de l’information médicale, CHU de Montpellier
European Clinical Research Infrastructure Network
Institut de Terapia Regenerativa Tissular
Interdisziplinäres Zentrum Klinische Studien (IZKS)
Nantes University Hospital
National University of Ireland, Galway, Ireland
Rennes University Hospital
Univercell-Biosolutions S.A.S
Université Montpellier
University of Navarra
University of Valladolid

Treatments:

Lidocaine