chronic discogenic low back pain. Intervertebral disc disorders with radiculopathy, lumbar region
Conditions
Interventions
Intervention group: depending on the number of involved levels,intradiscal injection of one to two vials consisting of 9 million bone marrow-derived allogenic mesenchymal cells suspension in 1 ml of n
Sponsors
ATI tech pharmed
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age more than 18 years both genders mild to moderate intervertebral disc degeneration in one to three levels Pfirrmann grade 3 to 6 (annulus fibrosus is able to maintain cell transplantation) Modic grade II or less in magnetic resonance imaging (MRI) with or without disc bulging lumbar pain visual analogue scale (VAS) : 3-9 back pain > radiculopathy Oswestry disability index (ODI):30-90 decrease in intervertebral disc height< 30% central disc bulging chronic back pain (atleast for three months in the last six months) which did not respond to symptomatic treatments including physical therapy and medication informed written consent
Exclusion criteria
Exclusion criteria: body mass index (BMI)>35 kg/m2 Kellgren Knee osteoarthritis grading 3 or more inherited or acquired disease leading to spine deformation,which will impede cell transplantation segmental instability of spine, spine canal stenosis, spondylitis, spondylolisthesis ,other spondyloarthropathies and other diseases that might interfere with the study prior history of disc surgery at the involved or adjacent levels any type of infections or lesions at the site of injection any issue in injection site that may make injection technically impossible prior history of intra-discal injection history of any type of epidural injection in the previous three months any type of neoplasm immuno-compromised or under treatment with immmuno-suppressant agents disrupted hematological or biochemical laboratory results that causes contraindications for the invervention any type of coagulopathy or hemorrhagic diseased or treatment with anticoagulants positive viral tests for HIV, CMV, HCV, HBV, HTLV 1&2 history or clinical diagnosis of severe osteoporosis known uncontrolled co-morbidities eg. diabetes(HbA1C>8%) or organ failure, liver (AST,ALT>100 U/L) kidney (Cr>2) and heart (EF<45%) movement disorders thyroid hormones disruption pregnancy or breast feeding opium or alcohol abuse history or clinical diagnosis of any type of psychosis allergy to substances that exist in culture media eg. gentamycin, bovine or horse serum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No observed short-term or long term, systemic or local, severe or mild and related or unrelated to cell therapy adverse effects. Timepoint: before intervention, 1 week , 1, 3, 6 months after intervention. Method of measurement: by using CTCAE v5. | — |
Secondary
| Measure | Time frame |
|---|---|
| Decreased pain after injection. Timepoint: 1, 3, 6 months after intervention. Method of measurement: visual analogue scale.;Decrease of patient's disability after injection. Timepoint: 1, 3, 6 months after injection. Method of measurement: Oswestry disability index.;Improved quality of life after injection. Timepoint: 6 months after injection. Method of measurement: 36-item short Form Survey (SF-36).;Increased disc height after injection. Timepoint: 6 months after injection. Method of measurement: MRI.;Increased Apparent diffusion coefficient of intervertebral disc. Timepoint: 6 months after injection. Method of measurement: DIFFUSION TENSOR IMAGING in MRI.;Decrease in grading of disc degeneration. Timepoint: 6 months after injection. Method of measurement: Scoring Pfirmann using MRI. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahtab Ahmadi pour
Royan Institute
Outcome results
None listed