Clinical Trial

Efficacy of Intradiscal Injection of Autologous BM-MSC in Subjects With Chronic LBP Due to Multilevel Lumbar IDD

Study acronym: DREAM

Recruiting Phase 2

Record status

This record was last updated May 25, 2025 (before its estimated October 31, 2025 completion). Its status may not reflect the trial's current state.

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).

Protocol Amendment History 1 amendment

This ClinicalTrials.gov record has been amended once since 2021-10-01.

Trial Details

NCT Number	NCT05066334
Lead Sponsor	Fondazione Policlinico Universitario Campus Bio-Medico Collaborators: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Center for Outcomes Research and Clinical Epidemiology, Italy
Conditions	Intervertebral Disc Degeneration, Chronic Low-back Pain
Enrollment	52 participants
Start Date	2021-03-22
Primary Completion	2025-10-31 (estimated)
Study Completion	2025-10-31 (estimated)
Updated on ClinicalTrials.gov	2025-05-25