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RECRUITING
NCT05066334
PHASE2

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

Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico

View on ClinicalTrials.gov

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).

Official title: Intervertebral Disc Regeneration Mediated by Autologous Mesenchymal Stem/Stromal Cells Intradiscal Injection: a Phase IIB Randomized Clinical Trial - DREAM Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2021-03-22

Completion Date

2025-10-31

Last Updated

2025-05-25

Healthy Volunteers

No

Interventions

DRUG

Autologous BM-MSC

intradiscal injection of autologous bone marrow mesenchymal stromal cells

PROCEDURE

Sham

local anaesthesia, no disc injection, no placebo injection

Locations (1)

Campus Bio-Medico University of Rome

Roma, Italy, Italy