Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-24 @ 1:00 PM
NCT ID:
NCT03737461
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03737461
Study Brief:
Protocol Section:
NCT03737461