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ACTIVE NOT RECRUITING
NCT03737461
PHASE2/PHASE3

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

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

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.

Official title: A Phase 2/3 Prospective, Multicentre Randomized, Double-blind Trial, Comparing Intra-discal Allogeneic Adult BM-MSC Therapy and Sham-treated Controls in Subjects With Chronic LBP Due to Lumbar DDD Unresponsive to Conventional Therapy

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

113

Start Date

2019-02-18

Completion Date

2026-03-08

Last Updated

2025-09-30

Healthy Volunteers

No

Interventions

DRUG

Allogenic BM-MSCs Injection

Cell dose will be 20±5 million cells suspended in 2 ml of HypoThermosol isotonic transport solution

OTHER

Sham Procedure

sham-maneuver as in the cell-treated patients are added, consisting in anesthetic infiltration with 2 ml of 1% xylocaine in the paravertebral muscles close to the affected segment.

Locations (9)

UH Montpellier

Montpellier, France

CHU de Nantes

Nantes, France

CHU Saint Antoine

Paris, France

APHP Cochin

Paris, France

BG Klinikum Bergmannstrost

Halle, Germany

Campus Bio-Medico University of Rome

Roma, Italy

Institut de Teràpia Regenerativa Tissular

Barcelona, Spain

Clínica Universidad de Navarra

Pamplona, Spain

Hospital Sagrado Corazón Valladolid

Valladolid, Spain