Efficacy of intradiscal injection of BM-MSC in subjects with chronic LBP due to lumbar DDD unresponsive to conventional therapy.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 112

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

- 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:
oOral corticosteroid therapy within the previous 3 months, OR
oIntramuscular, 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.
?

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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