NCT05066334 Efficacy of Intradiscal Injection of Autologous BM-MSC in Subjects With Chronic LBP Due to Multilevel Lumbar IDD
| NCT ID | NCT05066334 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fondazione Policlinico Universitario Campus Bio-Medico |
| Condition | Intervertebral Disc Degeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2021-03-22 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 52 participants in total. It began in 2021-03-22 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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 aspartate aminotransferase \[AST\] \> 1.5 × upper limit of normal \[ULN\]), renal, pancreatic or biliary disease, blood coagulation disorders, anemia or platelet count of \< 100 × 10\^9/L. * Pregnant or lactating women, or premenopausal women not using an acceptable form of birth control, are ineligible for inclusion. Contraception will be maintained during treatment and until the end of relevant systemic exposure. Additional pregnancy testing will be performed at the end of relevant systemic exposure. The patients will be required to use contraception from initial treatment administration until 24 months after the last dose of study drug. * In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is strongly recommended. * Positive serology for following infection: Syphilis, HIV, Hepatitis B, or C. * Contraindication to MRI assessed by the investigator. * Intolerance or allergy to local anaesthesia. * Any history of Cancer or immunodeficiency disease. * Previous transplantation.
Contact & Investigator
Gianluca Vadalà, MD, PhD
PRINCIPAL INVESTIGATOR
Campus Bio-Medico University of Rome
Frequently Asked Questions
Who can join the NCT05066334 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Intervertebral Disc Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05066334 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05066334 currently recruiting?
Yes, NCT05066334 is actively recruiting participants. Contact the research team at g.vadala@gmail.com for enrollment information.
Where is the NCT05066334 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT05066334 clinical trial?
NCT05066334 is sponsored by Fondazione Policlinico Universitario Campus Bio-Medico. The principal investigator is Gianluca Vadalà, MD, PhD at Campus Bio-Medico University of Rome. The trial plans to enroll 52 participants.