Efficacy of Intradiscal Injection of BM-MSC in Subjects With Chronic Low Back Pain (LBP) Due to Lumbar Degenerative Disc Disease (DDD) Unresponsive

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Montpellier
• Collaborators: APHP; BG Klinikum Bergmannstrost, Halle, Germany; Campus Bio-Medico University; Centre National de la Recherche Scientifique, France; Citospin; Département de l'information médicale, CHU de Montpellier; Département de l’information médicale, CHU de Montpellier; European Clinical Research Infrastructure Network; Institut de Terapia Regenerativa Tissular; Interdisziplinäres Zentrum Klinische Studien (IZKS); Nantes University Hospital; National University of Ireland, Galway, Ireland; Rennes University Hospital; Univercell-Biosolutions S.A.S; Université Montpellier; University of Navarra; University of Valladolid
• Treatments: Lidocaine

Criteria

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.