Active, not recruiting
Phase 2/3
Efficacy of Intradiscal Injection of BM-MSC in Subjects With Chronic Low Back Pain (LBP) Due to Lumbar Degenerative Disc Disease (DDD) Unresponsive
Condition(s) studied
Recurrent Low Back PainDegenerative Disc Disease (DDD)
Investigational drug(s) / intervention(s)
Allogenic BM-MSCs InjectionSham Procedure
Allogenic BM-MSCs Injection: Cell dose will be 20±5 million cells suspended in 2 ml of HypoThermosol isotonic transport solution
Sham Procedure: sham-maneuver as in the cell-treated patients are added, consisting in anesthetic infiltration with 2 ml of 1% xylocaine in the paravertebral muscles close to the affected segment.
Study summary
This will be a multicenter, prospective, double blind, randomized phase 2/3 trial comparing culture-expanded allogeneic adult BM-MSCs with sham-treated controls.
This trial will evaluate the efficacy of intradiscal injection of BM-MSCs in chronic low back pain due to lumbar degenerative disc disease (DDD) unresponsive to conventional therapy .
Visual analog scale (VAS) and functional status (by Oswestry Disability Index - ODI) will be evaluated 12 months after treatment, defining responders in case of improvement of VAS for pain of at least 20% and 20 mm between baseline and month 12, or improvement of ODI of 20% between baseline and month 12.
Eligibility
Inclusion Criteria:
* Age between 18 and 60 years.
* Symptomatic chronic low back pain unresponsive to conservative therapy (including physical therapy performed during at least 1 month before inclusion and 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 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
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:
* 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.
* 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 3 levels, or DDD on 2 levels but not adjacent, or DDD with modic 2 or 3 phases
* Patients not eligible to the intravertebral disc 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 × 109/
* 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.
Primary outcome measure(s)
- Change from Baseline Pain Clinical response at 12 months — baseline to month 12
The clinical response is defined as the Pain relief measure with Visual Analogue Scale (VAS) of at least 20 mm decrease on VAS scale between baseline and month 12.
- Change from Baseline Oswestry Disability Index (ODI) measure at 12 months — baseline to month 12
at least 20% improvement of functional index ODI at month 12 compared to baseline.
Trial sites (9)
| Facility | City | Region | Status |
| UH Montpellier |
Montpellier |
France |
|
| CHU de Nantes |
Nantes |
France |
|
| CHU Saint Antoine |
Paris |
France |
|
| APHP Cochin |
Paris |
France |
|
| BG Klinikum Bergmannstrost |
Halle |
Germany |
|
| Campus Bio-Medico University of Rome |
Roma |
Italy |
|
| Institut de Teràpia Regenerativa Tissular |
Barcelona |
Spain |
|
| Clínica Universidad de Navarra |
Pamplona |
Spain |
|
| Hospital Sagrado Corazón Valladolid |
Valladolid |
Spain |
|