BridgeMD
Trial comparing intra-discal allogeneic adult BM-MSC therapy and sham-treated controls in subjects with chronic low back pain due to lumbar degenerative disc disease unresponsive to conventional therapy
EU CTIS ID: 2023-510000-45-00
What this study is testing
The first co-primary objective is to assess the efficacy of intradiscal injection of allogeneic BM-MSCs in reducing chronic low back pain due to lumbar DDD using the visual analog scale (VAS) and functional status assessed by the Oswestry disability index (ODI) after 12 months of treatment, defining a responder as a patient with an improvement of VAS for pain of at least 20% and 20 mm between baseline and month 12, or with an improvement of ODI of 20% between baseline and month 12. The second co-primary objective is to assess the efficacy of intradiscal injection of allogeneic BM-MSCs in increasing disc fluid content, measured by quantitative Magnetic Resonance Imaging, between baseline and month 12.
- Phase II and Phase III (Integrated)
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 60 years at pre-screening visit
- Symptomatic chronic low back pain unresponsive to conservative therapy (including pain medication with level 2 analgesics in failure or intolerant to level during at least 1 month) for at least 3 months
- DDD assessed by (Pfirrmann’s score modified Griffith et al) grade 4 to 7 at one level. If second level, it should be adjacent (Pfirrmann’s score 1-4 maximum)
- Low back Pain at screening > 40 mm on VAS (0-100)
- NSAID washout of at least 2 days before screening
- Painkillers washout of at least 24 hours before screening
You likely can't join if
- Congenital or acquired diseases leading to spine deformations that may upset cell application (hyperlordosis, scoliosis, isthmus lesion, sacralisation and hemisacralisation)
- Patients contre-indicated to intravertebral disc rescue surgery
- Patients who have the risk to undergo a surgery in the next 6 months
- 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 × 10^9/L
See the full eligibility criteria
- Age between 18 and 60 years at pre-screening visit
- Symptomatic chronic low back pain unresponsive to conservative therapy (including pain medication with level 2 analgesics in failure or intolerant to level during at least 1 month) for at least 3 months
- DDD assessed by (Pfirrmann’s score modified Griffith et al) grade 4 to 7 at one level. If second level, it should be adjacent (Pfirrmann’s score 1-4 maximum)
- Low back Pain at screening > 40 mm on VAS (0-100)
- NSAID washout of at least 2 days before screening
- Painkillers washout of at least 24 hours before screening
- Congenital or acquired diseases leading to spine deformations that may upset cell application (hyperlordosis, scoliosis, isthmus lesion, sacralisation and hemisacralisation)
- Patients contre-indicated to intravertebral disc rescue surgery
- Patients who have the risk to undergo a surgery in the next 6 months
- 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 × 10^9/L
- Significant medical problems, such as uncontrolled hypertension, symptomatic heart failure; or any other clinically relevant condition or current medication that in the opinion of the investigator contra-indicates the use of any of the study or rescue medications
- Pregnant or lactating women, or premenopausal women not using an acceptable form of birth control, are ineligible for inclusion. Contraception has to be maintained during treatment and until the individual end of the study (M24). In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is strongly recommended. Methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation : oral, injectable, implantable, intrauterine device (IUD), intrauterine hormone-releasing system ( IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence are ineligible for inclusion.
- Positive serology for following infection: Syphilis, HIV, Hepatitis B, Hepatitis C or HTLV
- Contraindication to MRI assessed by the investigator
- Intolerance or allergy to local anesthesia
- Symptomatic posterior lumbo-articular osteoarthritis or predominant facet syndrome (osteophyte and facet hypertrophy)
- Any history of Cancer or immunodeficiency disease
- History of transfusion or transplantation
- Current sick leave due to work accident
- Prisoners or subjects who are involuntary incarcerated
- Patients subject to legal protection measures
- 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
- Spinal segmental instability (defined by lumbar dynamic X-Ray in extension/flexion with antero-post translation > 3 mm and/or angular mobility > 15°)
- Spinal canal stenosis (Schizas score > B)
- History of spinal infection
- History of lumbar disc herniation with non truncated sciatica or cruralgia, as well as lumbar cysts and radiculopathy
- Previous discal puncture or previous spine surgery
- DDD on 2 or 3 levels but not adjacent, or DDD with modic 2 or 3 phases
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.