Efficacy of Intradiscal Injection of BM-MSC in Subjects With Chronic Low Back Pain (LBP) Due to Lumbar Degenerative Disc Disease (DDD) Unresponsive
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Change from Baseline Pain Clinical response at 12 months — baseline to month 12
The clinical response is defined as the Pain relief measure with Visual Analogue Scale (VAS) of at least 20 mm decrease on VAS scale between baseline and month 12. - Change from Baseline Oswestry Disability Index (ODI) measure at 12 months — baseline to month 12
at least 20% improvement of functional index ODI at month 12 compared to baseline.
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More University Hospital, Montpellier trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03737461 on ClinicalTrials.gov ↗ ← All trials in Spain