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IRCT20080728001031N35 IRCT 2022-10-08 Royan Institute Chronic low back pain nucleus pulposus Safety of intradiscal injection of nucleus pulposus derived stromal cells in regeneration of human degenerated lumbar disc in patients with chronic low back pain 2017-12-25 anticipated 5 Complete https://irct.ir/trial/34 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 chronic low back pain. Injection of stem cells derived from the intervertebral disc. 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 Not decided
public Massoud Vosough
Eastern Hafez St, Northern Banihashem St, 45 m Resalat highway
Tehran Iran (Islamic Republic of) 148- 16635 +98 21 2251 8388 masvos@yahoo.com Royan Institute scientific Nasser Aghdami
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
Tehran Iran (Islamic Republic of) 1665664511 +98 21 2251 8388 nasser.aghdami@royaninstitute.org Royan Institute Iran (Islamic Republic of) Age between 18 and 65 years Of both sexes Degenerative intervertebral disc in one or two lumbar intervertebral discs with pain that has not responded to previous supportive therapies, including the use of conventional analgesics or physiotherapy within the last 6 months. Confirmation of fibrous ring integrity for cell implantation by magnetic resonance imaging (MRI) Reduction of intervertebral disc height by 50% or more based on radiography. Do not have a vertebral infection. Have no uncontrolled chronic underlying disease that is prohibited for treatment. Have no uncontrolled chronic underlying disease that is prohibited for treatment. Do not be pregnant or breastfeeding women. Not positive and transmissible viral infection. 18 years 65 years Both infection signs or positive serology for HIV, hepatitis and syphilis allergy to gentanicin, or to bovine, cattle or horse serum congenital or acquired disease leading to spine deformities that may upset cell application spinal segmental instability, spinal canal stenos, isthmus pathology, and other conditions that may compromise the study modic 3 changes on MRI images overweight with body mass index greater than 30.5 neoplasia immunosuppression participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study other conditions that may, according to medical criteria, discourage participation in the study. M51.1 Lumbar and other intervertebral disc disorders with radiculopathy Other Injection of stem cells derived from the intervertebral disc Clinical examination. Timepoint: 1- Within one month after discharge every week. Method of measurement: 1- Within one month after discharge every week: Responsible: Specialist: Action plan: Clinical examination, examination of complications of surgery or aspiration. Evaluation of complications of surgery or aspiration. Timepoint: 2-6 weeks after injection. Method of measurement: 2-6 weeks after injection: Responsible: Specialist: Action plan: Clinical examination, examination of complications of operation or aspiration. Clinical examination and evaluation of the safety. Timepoint: Three months after injection. Method of measurement: Three months after injection: Responsible: Physician specializing in measures: Evaluation of treatment safety by evaluating questionnaires for examination of complications and clinical examinations. Blood and urine tests. Timepoint: 6 months after injection. Method of measurement: six months after injection: Responsible: Physician specializing in measures blood and urine tests. The effect of treatment by MRI. Timepoint: one year after injection. Method of measurement: one year after injection: Responsible: specialist doctor Measurs assessment of the effectiveness of treatment by MRI. Royan Institute Approved 2010-08-20 Ethics committee of Royan infertility institute Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway Tehran Tehran Iran (Islamic Republic of)