Efficacy of Intradiscal Injection of Autologous BM-MSC in Subjects With Chronic LBP Due to Multilevel Lumbar IDD
Status:
Recruiting
Trial end date:
2023-06-09
Target enrollment:
Participant gender:
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).
Phase:
Phase 2
Details
Lead Sponsor:
Campus Bio-Medico University
Collaborators:
Center for Outcomes Research and Clinical Epidemiology, Italy Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico