MSV/AS for Degenerative disc disease | Chronic low back pain

Inclusion criteria

• {"criterion_text":"-Age between 18 and 60 years at pre-screening visit"}
• {"criterion_text":"-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"}
• {"criterion_text":"-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)"}
• {"criterion_text":"-Low back Pain at screening > 40 mm on VAS (0-100)"}
• {"criterion_text":"-NSAID washout of at least 2 days before screening"}
• {"criterion_text":"-Painkillers washout of at least 24 hours before screening"}

Exclusion criteria

• {"criterion_text":"-Congenital or acquired diseases leading to spine deformations that may upset cell application (hyperlordosis, scoliosis, isthmus lesion, sacralisation and hemisacralisation)"}
• {"criterion_text":"-Patients contre-indicated to intravertebral disc rescue surgery"}
• {"criterion_text":"-Patients who have the risk to undergo a surgery in the next 6 months"}
• {"criterion_text":"-Obesity with body mass index (BMI in Kg/size in m2) greater than 35 (obesity grade II)"}
• {"criterion_text":"-Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study"}
• {"criterion_text":"-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"}
• {"criterion_text":"-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"}
• {"criterion_text":"-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."}
• {"criterion_text":"-Positive serology for following infection: Syphilis, HIV, Hepatitis B, Hepatitis C or HTLV"}
• {"criterion_text":"-Contraindication to MRI assessed by the investigator"}
• {"criterion_text":"-Intolerance or allergy to local anesthesia"}
• {"criterion_text":"-Symptomatic posterior lumbo-articular osteoarthritis or predominant facet syndrome (osteophyte and facet hypertrophy)"}
• {"criterion_text":"-Any history of Cancer or immunodeficiency disease"}
• {"criterion_text":"-History of transfusion or transplantation"}
• {"criterion_text":"-Current sick leave due to work accident"}
• {"criterion_text":"-Prisoners or subjects who are involuntary incarcerated"}
• {"criterion_text":"-Patients subject to legal protection measures"}
• {"criterion_text":"-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"}
• {"criterion_text":"-Spinal segmental instability (defined by lumbar dynamic X-Ray in extension/flexion with antero-post translation > 3 mm and/or angular mobility > 15°)"}
• {"criterion_text":"-Spinal canal stenosis (Schizas score > B)"}
• {"criterion_text":"-History of spinal infection"}
• {"criterion_text":"-History of lumbar disc herniation with non truncated sciatica or cruralgia, as well as lumbar cysts and radiculopathy"}
• {"criterion_text":"-Previous discal puncture or previous spine surgery"}
• {"criterion_text":"-DDD on 2 or 3 levels but not adjacent, or DDD with modic 2 or 3 phases"}

Primary endpoints

• {"endpoint_text":"-Clinical response is defined as pain relief of at least 20% and 20 mm decrease on VAS scale between baseline and month 12, or 20% improvement of functional index ODI at month 12 compared to baseline. VAS pain scale (0 – 100, where 0 represents no pain and 100 represents the worst pain imaginable). Oswestry disability index scale ranges from 0 to 50 (0%–20%:minimal disability; 20%–40%:moderate disability; 40%–60%:severe disability; 60%–80%:crippled; 80%–100%:bed-bound/exaggerating their symptoms","definition_or_measurement_approach":"Measured by VAS pain scale (0–100) and Oswestry Disability Index (ODI, 0–50). Responder defined as ≥20% and 20 mm decrease in VAS between baseline and month 12, or ≥20% improvement in ODI at month 12 vs baseline."}
• {"endpoint_text":"-Fluid content of the discs will be determined from T2-weighted sagittal images, and measured in the affected disc segment and in the contiguous 3 to 5 segments (Methods and Orozco et al). The fluid content values of the affected discs will be normalized to the values obtained from the healthy discs in the same individual (average value of the healthy discs). The change in fluid content is expressed as the ratio of fluid content at months 12 vs fluid content at baseline.","definition_or_measurement_approach":"Quantitative measurement from T2-weighted sagittal MRI images; values normalized to healthy discs in same subject; change expressed as ratio of month 12 vs baseline."}
• {"endpoint_text":"-Evolution of affected disc(s) by quantitative Magnetic Resonance Imaging (MRI) density measurements in T2 and T1spin/echo and T1rho weighted images performed at screening, 12 and 24 months used as an indication of disc fluid and GAG content. The \"quality\" of the patient's lumbar disc will be monitored non-invasively using T2-weighted MRI sagittal images and, in T1spin/echo MRI.","definition_or_measurement_approach":"Quantitative MRI density measurements (T2, T1 spin/echo, T1rho) at screening, 12 and 24 months to indicate disc fluid and glycosaminoglycan (GAG) content."}

Secondary endpoints

• {"endpoint_text":"-Disability and quality of life evolution include Short Form (SF)-36 scores, global assessment by the patient and the physician. Overall pain intensity in the lumbar spine (1 = none, 2 = mild, 3 = moderate, 4 = severe, 5 = extreme); patient's global assessment of disease activity (1 = very good, 2 = good, 3 = fair, 4 = poor, 5 = very poor); physician's global assessment of disease activity (1 = very good, 2 = good, 3 = fair, 4 = poor, 5 = very poor)","definition_or_measurement_approach":"Measured by SF-36 scores and patient/physician global assessments; overall pain intensity scale 1–5 as described."}
• {"endpoint_text":"-de-/increase in rescue painkillers medication","definition_or_measurement_approach":"Change in use of rescue analgesic medication compared to baseline (frequency/amount)."}
• {"endpoint_text":"-drug consumption of painkillers","definition_or_measurement_approach":"Assessment of analgesic consumption (type and dose) throughout the study at each visit; paracetamol and level 2 analgesics monitored."}
• {"endpoint_text":"-Employment and work status","definition_or_measurement_approach":"Assessment of employment/work status changes between baseline and follow-up time points."}
• {"endpoint_text":"-medical and non-medical costs","definition_or_measurement_approach":"Health economic assessment of medical and non-medical costs."}
• {"endpoint_text":"-Immune response","definition_or_measurement_approach":"Assessment of immune response associated with allogeneic cell injection (quantification of anti-HLA in all patients)."}
• {"endpoint_text":"-Safety Outcomes","definition_or_measurement_approach":"Safety and tolerability assessed by nature and severity of adverse events, including procedure-related events; both acute and long-term safety analyzed."}

Germany

Earliest CTIS Part Ii Submission Date

29-10-2024

Latest Decision Or Authorization Date

19-11-2024

Processing Time Days

21

Number Of Sites

1

Number Of Participants

11

Primary sponsor

Full Name

University Hospital Of Montpellier

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France