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

NCT05066334 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-05-25

No results posted yet for this study

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).

Conditions

  • Intervertebral Disc Degeneration
  • Chronic Low-back Pain

Interventions

DRUG

Autologous BM-MSC

intradiscal injection of autologous bone marrow mesenchymal stromal cells

PROCEDURE

Sham

local anaesthesia, no disc injection, no placebo injection

Sponsors & Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    collaborator OTHER

  • Center for Outcomes Research and Clinical Epidemiology, Italy

    collaborator OTHER

  • Fondazione Policlinico Universitario Campus Bio-Medico

    lead OTHER

Principal Investigators

  • Gianluca Vadalà, MD, PhD · Campus Bio-Medico University of Rome

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-22
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05066334 on ClinicalTrials.gov