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Tests treatment safety and results for Intervertebral Disc Degeneration
Official title Efficacy of Intradiscal Injection of Autologous BM-MSC in Subjects With Chronic LBP Due to Multilevel Lumbar IDD
ClinicalTrials.gov ID: NCT05066334
What this study is testing
What is Autologous BM-MSC?
Autologous BM-MSC is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for intervertebral disc degeneration.
Also referred to as Treated.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- Annulus fibrosus intact, demonstrated by MRI.
- Pain baseline \> 40 mm on VAS (0- 100).
- NSAID washout of at least 2 days before screening.
You likely can't join if
- Congenital or acquired diseases leading to spine deformations that may upset cell application (scoliosis, isthmus lesion, sacralization and...
- 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
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Roma, Italy, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roma, Italy, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.