Ischemic stroke. Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries
Conditions
Interventions
Intervention: Injection of stem cells into middle cerebral artery during angiography (one injection of cbMNCs via intra-arterial route at the dose of 3 million cells/kg in 2 min).
Treatment - Other
Intervention: Injection of stem cells into middle cerebral artery during angiography (one injection of cbMNCs via intra-arterial route at the dose of 3 million cells/kg in 2 min)
Sponsors
Vice Chancellor for Research and Technology, Iran University of Medical Sciences
Iranian council for development of Stem cell sciences & Technologies, Vice presidency for Science an
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: age: 18-75; MRI or CT scan with infarct in middle/anterior cerebral artery without hematoma; ischemic storke with 7 -30 days before; Glasgow Coma Scale score >8; BI score of =50, National Institute of Health stroke scale (NIHSS) score of =7; inability to raise arms to 90 degrees; stable condition more than 48 hours, normal body temperature; normal blood pressure with mean arterial pressure90 mmHg); normal blood sugar<200 mg/dl; normal urea/electrolyte. Exclusion criteria: lacunar syndrome; intubation; posterior circulation stroke; morbidity likely to limit survival to less than 3 years; pre-stroke disability leading to dependence on others for activity of daily living; inaccessibility for follow up; allergy to local anesthetic; unwillingness to provide written informed consent; symptoms suggestive of acute cardiac; hepatic or renal disease; pregnancy; HIV positivity; participation in any other trial; poor access vessel angiography; Fever.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score of NIHSS scale. Timepoint: On 0, 30th, 90th and 180th days after cell injection. Method of measurement: NIHSS questionnaire (0-42) score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of Epilepsy. Timepoint: On 90th and 180th day after injection. Method of measurement: EEG.;MRS score. Timepoint: On 0, 90th and 180th days after injection. Method of measurement: MRS questionnair with score 0-6.;BI score. Timepoint: On 0, 90th and 180th days after cell injection. Method of measurement: BI questionnaire with sore (0-100).;Evaluation of structural brain function by MRI. Timepoint: On 0, 30th, 90th and 180th days after injection. Method of measurement: Results of volume of infarction and lateral ventricles before and after cell injection by MRI. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFereshteh Azedi Tehrani
Department of Neuroscience, Faculty of Advanced Technologies in Medicine, Iran University of Medical
Outcome results
None listed