Efficacy of Intradiscal Injection of Autologous BM-MSC in Subjects With Chronic LBP Due to Multilevel Lumbar IDD
Unknown statusPhase 2NCT05066334
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- Intervertebral Disc Regeneration Mediated by Autologous Mesenchymal Stem/Stromal Cells Intradiscal Injection: a Phase IIB Randomized Clinical Trial - DREAM Trial
- Conditions
- Intervertebral Disc Degeneration
- Chronic Low-back Pain
- Interventions
- Drug: Autologous BM-MSC
- Procedure: Sham
- Sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico; Center for Outcomes Research and Clinical Epidemiology, Italy
- Start date
- 2021-03-22
- Primary completion
- 2025-10-31
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Italy
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Signed informed consent. * Symptomatic chronic LBP due to moderate IDD (modified Pfirrmann score 3-4, Griffith score 3-7) at max.3 levels of the lumbar spine unresponsive to conservative treatment, physical and medical for at least 6 months. Physical treatment includes physiotherapy. Medical treatments includes nonsteroidal anti-inflammatory drugs (NSAID), paracetamol, opioids and myorelaxant. * Annulus fibrosus intact, demonstrated by MRI. * Pain baseline \> 40 mm on VAS (0- 100). * NSAID washout of at least 2 days before screening. * Painkillers washout of at least 24 hours before screening. * For females of childbearing potential, a negative pregnancy test must be documented at Screening. * Men and women should use effective contraception during treatment and for at least 24 months after BM-MSC discontinuation. As a precautionary measure, breast-feeding should be discontinued during treatment with BM-MSC and should not be restarted after discontinuation of BM-MSC. Exclusion Criteria: * Congenital or acquired diseases leading to spine deformations that may upset cell application (scoliosis, isthmus lesion, sacralization and hemisacralization, degenerative spondylolisthesis). * Spinal segmental instability assessed by dynamic X-Ray. * Symptomatic facet joints syndrome on MRI (facet joints hyperintensity and hypertrophy evaluated at coronal T2 weighted MRI). * Prior to the screening visit, has received: * Oral corticosteroid therapy within the previous 3 months, OR * Intramuscular, intravenous or epidural corticosteroid therapy within the previous 3 months * Presence of a 4th level with symptomatic IDD (modified Pfirrmann score 3-4, Griffith score 3-7) in the lumbar spine. * Spinal canal stenosis (Schizas score \> B). * History of spinal infection. * Lumbar disc herniation and sciatica. * Endplate abnormality such as Schmorl's Nodes. * Previous discal puncture or previous spine surgery. * IDD with Modic II and III changes on MRI images. * Patients not eligible to the intravertebral disc surgery. * Patients who have the risk to undergo a surgery in the next 6 months. * Patients with local infusion device/devices for corticosteroids. * Obesity with body mass index (BMI in Kg/size in m\^2) greater than 35 (obesity grade II). * Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study. * Abnormal blood tests: hepatic (alanine amino transferase \[ALT\] and/or as…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05066334