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Efficacy of intradiscal injection of autologous BM-MSC in subjects with chronic LBP due to multilevel lumbar IDD
EU CTIS ID: 2024-519112-14-00
What this study is testing
Evaluate the effectiveness of intradiscal injection of autologous BM-MSCs in reducing chronic LBP due to multilevel (max. 3 levels) lumbar IDD after 12 months of treatment in terms of pain relief (VAS), functionality (ODI) and quality of life (SF36)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age between 18 and 65 years
- Signed informed consent
- Symptomatic chronic LBP due to moderate IDD [modified Pfirrmann score 3-4 (Pfirrmann et al., 2001), Griffith score 3-7(Griffith et al., 2007)] 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 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
You likely can't join if
- Congenital or acquired diseases leading to spine deformations that may upset cell application (scoliosis, isthmus lesion, sacralization and hemisacralization, degenetative spondilolisthesis
- Endplate abnormality such as Schmorl’s Nodes
- Previous discal puncture or previous spine surgery.
- IDD with Modic 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
See the full eligibility criteria
Who can join
- Age between 18 and 65 years
- Signed informed consent
- Symptomatic chronic LBP due to moderate IDD [modified Pfirrmann score 3-4 (Pfirrmann et al., 2001), Griffith score 3-7(Griffith et al., 2007)] 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 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 (see definitions in paragraph 6.5), 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. The complete list of contraceptive methods is described in the patient information sheet and in the paragraph 6.5. As a precautionary measure, breast-feeding should be discontinued during treatment with BM-MSC and should not be restarted after discontinuation of BM-MSC.
What rules you out
- Congenital or acquired diseases leading to spine deformations that may upset cell application (scoliosis, isthmus lesion, sacralization and hemisacralization, degenetative spondilolisthesis
- Endplate abnormality such as Schmorl’s Nodes
- Previous discal puncture or previous spine surgery.
- IDD with Modic 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 m2) 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 aminotransferase [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 × 109/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.
- Spinal segmental instability assessed by dynamic X-Ray
- In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is strongly recommended. The complete list of contraceptive methods is described in the patient information sheet and in the paragraph 6.5. 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.
- Symptomatic facet joints syndrome on MRI (facet joints iperintensity and ipertrophy evaluated at coronal T2 weighted MRI).
- Prior to the screening visit, has received: - Oral corticosteroid therapy within the previous 1 month, OR
- Intramuscular, intravenous or epidural corticosteroid therapy within the previous 1 month.Presence of a 4th level with symptomatic IDD (modified Pfirrmann score 3- 4, Griffith score 3-7) in the lumbar spine
- 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
The study team makes the final eligibility decision.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.