Degenerative Disc Disease
Conditions
Interventions
Product Name: Células mesenquimales troncales adultas alogénicas de medula ósea expandidas
Product Code: MSV2
Pharmaceutical Form: Concentrate for suspension for injection
INN or Proposed INN: Células
Sponsors
University Hospital of Montpellier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age between 18 and 60 years. - Symptomatic chronic low back pain unresponsive to conservative therapy (including physical therapy) 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 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 112 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Congenital or acquired diseases leading to spine deformations that may upset cell application (hyperlordosis, scoliosis, isthmus lesion, sacralization and hemisacralization). - Symptomatic posterior lumbo-articular osteoarthritis or predominant facet syndrome on Xray or MRI (osteophyte and facet hypertrophy). - Prior to the screening visit, has received: o Oral corticosteroid therapy within the previous 3 months, OR o 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. ? Lumbar disc herniation with non truncated sciatica or cruralgia. ? Previous discal puncture or previous spine surgery. ? DDD on 3 levels, or DDD on 2 levels but not adjacent, or DDD with modic 2 or 3 phases ? 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. - 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. - Positive serology for following viral infection: HIV, Hepatitis B, or Hepatitis C. - Contraindication to MRI assessed by the investigator. - Intolerance or allergy to local anaesthesia. - Any history of Cancer or immunodeficiency disease. - Previous transfusion or transplantation. ?
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - To evaluate the efficacy of intradiscal injection of allogeneic BM-MSCs using VAS and ODI after 3, 6 and 24 months of treatment, defining responders in case of at least 20% of improvement in VAS for pain compared to Baseline. - Assess efficacy of allogeneic stem cell treatments for DDD on modification of VAS between baseline and 3, 6, 12 and 24 months. - Evaluate modification of disability (ODI),quality of life (SF-12 scores), overall pain intensity, and global assessment by the patient and the physician, between baseline and 3, 6 , 12 and 24 months. - Evaluate modification of affected disc by quantitative Magnetic Resonance Imaging (MRI) between baseline, 6, 12, and 24 months - Assess modification of employment and work status between baseline and months 12 and 24. - Assess safety and tolerability, measured by the number of participants with adverse events. - Assess immune response associated with allogeneic cells injection;Main Objective: - Co-Primary objectives: To evaluate 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. To evaluate the efficacy of intradiscal injection of BM-MSCs in increasing disc fluid content, measured by quantitative Magnetic Resonance Imaging, between baseline and month 12.;Primary end point(s): The 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 Fluid content of the discs will be determined from T2-weighted sagittal images, and measured in the affected disc segment and in th | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Disability and quality of life evolution Employment and work status Structural assessment;Timepoint(s) of evaluation of this end point: 0, 3, 6, 12 and 24 months | — |
Countries
France, Spain
Contacts
Public ContactChristian Jorgensen
University Hospital of Montpellier
Outcome results
None listed