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IRCT20080728001031N30 IRCT 2021-10-21 ATI tech pharmed 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 Safety evaluation of intra-discal transplantation of allogeneic clonal bone marrow derived mesenchymal stromal cells in patients with low back pain induced by degenerative disc disease: Interventional clinical trial, phase I 2021-09-23 anticipated 5 Complete https://irct.ir/trial/58723 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 chronic discogenic low back pain. 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 normal saline with 1 ml of hyaloronic acid (brand name: Hyalo Brix). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is confidentiality and ethical issues
public Mahtab Ahmadi pour
Royan Alley, Eastern Hafez St, Northern Banihashem St, 45 m Ghasem Soleymani Highway
tehran Iran (Islamic Republic of) 1665664511 +2122518388 mahtaab.ahmd@gmail.com Royan Institute scientific Masoud Vosough
Royan Alley, Eastern Hafez St, Northern Banihashem St, 45 m Ghasem Soleymani Highway
tehran Iran (Islamic Republic of) 1665664511 +2122518388 masvos@yahoo.com Royan Institute Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years no limit Both 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 M51.16 Intervertebral disc disorders with radiculopathy, lumbar region Treatment - Drugs 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 normal saline with 1 ml of hyaloronic acid (brand name: Hyalo Brix) 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. 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. ATI tech pharmed Approved 2021-07-13 Research Ethics committees of Royan Institute-Academic center for education,culture and research Royan Alley, Eastern Hafez St, Northern Banihashem St, 45 m Ghasem Soleymani Highway tehran Tehran Iran (Islamic Republic of)