drugset / Trial / NCT05066334
Efficacy of Intradiscal Injection of Autologous BM-MSC in Subjects With Chronic LBP Due to Multilevel Lumbar IDD
Phase 2
Recruiting
52 enrolled
Fondazione Policlinico Universitario Campus Bio-Medico
Center for Outcomes Research and Clinical Epidemiology, Italy · collabFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
DREAM is a phase II B efficacy monocentric, prospective, randomized, controlled double blinded trial, comparing intra-discal autologous adult bone marrow mesenchymal stem cells (BM-MSC) therapy and sham treated controls in subjects with chronic (\> 6 months) Low Back Pain (LBP) due to lumbar multilevel (max. 3 levels) intervertebral disc degeneration (IDD) unresponsive to conventional therapy. Duration of the recruitment period has been estimated to be 12 months. The efficacy of intradiscal injection of autologous BM-MSC in reducing chronic LBP due to multilevel lumbar IDD will be evaluated after 24 months in terms of pain relief (VAS), functionality (ODI) and quality of life (SF36).
Timeline
- Start
- 2021-03-22
- Primary completion
- 2025-10-31
- Completion
- 2025-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Autologous BM MSC | Cell therapy | 1.5e+07 unknown | Other |