Actively Recruiting
Intervertebral Disc Regeneration Using Autologous Mesenchymal Stem Cells Injection for Chronic Low Back Pain Due to Multilevel Lumbar Disc Degeneration: A Phase II B Randomized Trial DREAM
Led by Fondazione Policlinico Universitario Campus Bio-Medico · Updated on 2025-05-25
52
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the effectiveness and safety of injecting autologous adult bone marrow mesenchymal stem cells (BM-MSC) into the discs of patients with chronic low back pain caused by lumbar multilevel intervertebral disc degeneration (IDD) that has not improved with standard treatments. This phase II B, randomized, controlled, double-blind trial aims to assess pain relief, functionality, and quality of life over a 24-month period. The study is motivated by the need for restorative treatments beyond current pain-relieving therapies, as IDD is a major cause of low back pain affecting a large portion of the global population. Participants will undergo either the experimental treatment involving bone marrow harvesting followed by a single injection of 15 million BM-MSC cells per affected disc (up to three discs) or a sham procedure simulating these steps without actual cell injection. The study includes detailed imaging control to guide the injections. The trial will compare the effects of the active stem cell therapy to the sham treatment, with evaluations at multiple time points including MRI scans at 6 months, 1 year, and 2 years to assess disc regeneration. During the study, participants will have regular assessments including pain measurement using VAS, functional disability evaluations, quality of life questionnaires, drug use monitoring, spine examinations, blood tests, and safety monitoring at baseline and at intervals up to 24 months. Researchers will also assess structural changes in the discs, employment status, and costs related to treatment. The total participation time is 24 months, allowing long-term observation of efficacy and safety outcomes.
CONDITIONS
Brief 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.
- Adults aged 18 to 65 years.
- Chronic low back pain due to moderate intervertebral disc degeneration at up to 3 lumbar levels lasting more than 6 months unresponsive to conservative physical and medical treatments.
- Intact annulus fibrosus shown by MRI.
- Baseline pain score greater than 40 mm on Visual Analog Scale (VAS).
- NSAID washout for at least 2 days before screening.
- Painkiller washout for at least 24 hours before screening.
- Negative pregnancy test for females of childbearing potential at screening.
- Use of effective contraception during treatment and for 24 months after BM-MSC discontinuation.
- Breastfeeding discontinued during treatment and after BM-MSC discontinuation as precaution.
You will not qualify if you...
- Spine deformities such as scoliosis, isthmus lesion, sacralization, hemisacralization, or degenerative spondylolisthesis.
- Spinal segmental instability.
- Symptomatic facet joint syndrome on MRI.
- Recent corticosteroid therapy (oral, intramuscular, intravenous, or epidural) within 3 months before screening.
- Presence of a fourth symptomatic degenerative disc level 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.
- Modic type II or III changes in degenerative discs.
- Not eligible for intravertebral disc surgery.
- Expected surgery within 6 months.
- Use of local infusion devices for corticosteroids.
- Obesity with BMI over 35.
- Participation in another clinical trial or use of investigational product within 30 days before inclusion.
- Abnormal blood tests indicating liver, renal, pancreatic, biliary disease, blood coagulation issues, anemia, or low platelet count.
- Pregnant or lactating women, or premenopausal women not using acceptable birth control.
- Delayed menstrual period without confirmed absence of pregnancy.
- Positive serology 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment visit with follow-up assessments up to 24 months
Participants receive either a single injection of autologous bone marrow mesenchymal stromal cells into up to 3 affected discs or undergo a sham procedure with simulated injections under local anesthesia.
1 baseline visit and multiple follow-up visits at 3, 6, 12, and 24 months
Duration - 24 months
Participants are monitored for pain, functional disability, safety, and structural changes up to 24 months after treatment.
Follow-up visits at 3, 6, 12, and 24 months
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
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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