Actively Recruiting
Efficacy of Intradiscal Injection of Autologous BM-MSC in Subjects With Chronic LBP Due to Multilevel Lumbar IDD
Led by Fondazione Policlinico Universitario Campus Bio-Medico · Updated on 2025-05-25
52
Participants Needed
1
Research Sites
240 weeks
Total Duration
On this page
Sponsors
F
Fondazione Policlinico Universitario Campus Bio-Medico
Lead Sponsor
F
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Efficacy of Intradiscal Injection of Autologous BM-MSC in Subjects With Chronic LBP Due to Multilevel Lumbar IDD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent.
- Chronic low back pain due to moderate intervertebral disc degeneration at up to 3 lumbar levels, unresponsive to physical and medical treatment for at least 6 months.
- Intact annulus fibrosus confirmed by MRI.
- Baseline pain score greater than 40 mm on a 0-100 visual analog scale.
- At least 2 days without NSAIDs before screening.
- At least 24 hours without painkillers before screening.
- For women of childbearing potential, a negative pregnancy test at screening.
- Men and women must use effective contraception during treatment and for 24 months after BM-MSC treatment.
- Breastfeeding should be stopped during BM-MSC treatment and not restarted after treatment ends.
You will not qualify if you...
- Spine deformities such as scoliosis, isthmus lesion, sacralization, hemisacralization, or degenerative spondylolisthesis.
- Spinal instability shown by dynamic X-Ray.
- Symptomatic facet joint syndrome on MRI.
- Recent corticosteroid therapy within the past 3 months.
- Presence of a fourth symptomatic degenerated disc in lumbar spine.
- Spinal canal stenosis with Schizas score greater than B.
- History of spinal infection.
- Lumbar disc herniation and sciatica.
- Endplate abnormalities like Schmorl's Nodes.
- Previous disc puncture or spine surgery.
- Intervertebral disc degeneration with Modic II and III changes.
- Not eligible for disc surgery or likely to have surgery within 6 months.
- Use of local corticosteroid infusion devices.
- Obesity with BMI over 35.
- Participation in another clinical trial or investigational treatment within 30 days.
- Abnormal liver, kidney, pancreatic, biliary tests, blood coagulation issues, anemia, or low platelets.
- Pregnant or lactating women or women not using acceptable birth control.
- Positive tests for syphilis, HIV, hepatitis B or C.
- Contraindications to MRI.
- Allergy or intolerance to local anesthesia.
- History of cancer or immunodeficiency.
- Previous transplantation.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Campus Bio-Medico University of Rome
Roma, Italy, Italy, 00128
Actively Recruiting
Research Team
G
Gianluca Vadalà, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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