Safety of intra-discal transplantation of allogeneic clonal bone marrow derived mesenchymal stromal cells in patients with low back pain induced by degenerative disc disease
- Conditions
- chronic discogenic low back pain.Intervertebral disc disorders with radiculopathy, lumbar regionM51.16
- Registration Number
- IRCT20080728001031N30
- Lead Sponsor
- ATI tech pharmed
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 5
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method o 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 Outcome Measures
Name Time Method 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.