Efficacy of intra-discal injection of BM-MSC in subjects with chronic low back pain (LBP) due to degenerative disc disease (DDD) unresponsive (RESPINE)

ClinicalTrials.gov Identifier: NCT03737461
Nº EudraCT: 2017-002092-25

Objectives

Clinical trial to evaluate the efficacy of the intra-discal injection of BM-MSC in subjects with chronic low back pain due to degenerative lumbar disc disease that do not respond to conventional therapy.

Methodology

Phase II-III, multicentre, double-blind, controlled and randomized clinical trial. 112 adult patients with DDD are included.

The visual analogue scale (VAS) and the functional status (according to the Oswestry Disability Index – ODI) will be evaluated 12 months after treatment. Responders are defined as subjects with an improvement of VAS for pain of at least 20% and 20 mm between the beginning and month 12, or with an ODI improvement of 20% between the beginning and month 12.


STUDY DESCRIPTION

Multicentre study
Development phase: II-III
Status: ongoing
PEI: 04-031
Nº Eudra-CT: 2017-002092-25
ClinicalTrials.gov: NCT03737461
Code: UF 9766
ClinicalTrials.gov: NCT02483364
Sponsor: CHU Montpellier
Control: AEMPS, CEIm
Investigators: IP C Jorgensen, YM Pers, R Ferreira, M Alfonso, D Noriega, R Soler, E Bord, H Meisel, F Rannou, F Berenbaum, G Vadalà, J García-Sancho, A Sánchez, P Robin , A Powaska, MC Picot, C Duflos, …
Participating entities: CHU de Montpellier, Hôpital Lapeyronie,Universidad de Navarra, Hospital Universitario Valladolid, ITRT, Centre Hospitalier Universitaire de Nantes- France, BG Klinikum Bergmannstrost Halle- Germany, Hôpital Cochin-France, Hôpital Saint Antoine-France, Campus Bio-Medico University of Rome- Italy,IBGM-Universidad de Valladolid, Citospin, Universitätsmedizin der Johannes Gutenberg- Universität Mainz-Germany, European Clinical Research Infrastructure Network (ECRIN-ERIC), Le Centre National de la Recherche Scientifique Paris-France, University of Montpellier-France, Univercell-Biosolutions S.A.S-France, National University of Ireland Galway-Ireland.
Funding: Horizon 2020 – European Commission – Europa EU