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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
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
Allogenic BM-MSCs Injection
Cell dose will be 20±5 million cells suspended in 2 ml of HypoThermosol isotonic transport solution
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