chronic low back pain. Lumbar and other intervertebral disc disorders with radiculopathy
Conditions
Interventions
Injection of stem cells derived from the intervertebral disc.
Sponsors
Royan Institute
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMassoud Vosough
Royan Institute
Outcome results
None listed