IRCT2016051327865N1 IRCT 2016-11-08 Vice Chancellor for Research and Technology, Iran University of Medical Sciences The Safety and feasibility of Intra-Arterial Stem Cell Therapy In Patients with Sub-Acute Stroke - Evaluation of the safety and feasibility of delivering human umbilical cord mononuclear cells (cbMNCs) via catheter to the proximal end of the lesion artery in patients with sub-acute stroke in the territory of the middle cerebral artery 2016-08-22 anticipated 4 Complete https://irct.ir/trial/22739 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Other, Other design features: -. 1 Ischemic stroke. 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).

public Fereshteh Azedi Tehrani

Faculty of Advanced Technologies in Medicine, Iran University of Medical Sciences, Shahid Hemmat Highway

Tehran Iran (Islamic Republic of) 14665-354 +98 21 8670 4698 fazeditehrani@gmail.com, azeditehrani.f@tak.iums.ac.ir Department of Neuroscience, Faculty of Advanced Technologies in Medicine, Iran University of Medical scientific Masoud Mehrpour

Behafarin Avenue, Karimkhan Street

Tehran Iran (Islamic Republic of) 1593747811 +98 21 8214 1201 mehrpr@yahoo.com Iran University of Medical Sciences, Firoozgar General Hospital Iran (Islamic Republic of) 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 pressure<125 mmHg (with systolic blood pressur>90 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. 18 years 75 years Both I63.5 Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries 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) Score of NIHSS scale. Timepoint: On 0, 30th, 90th and 180th days after cell injection. Method of measurement: NIHSS questionnaire (0-42) score. 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. Iranian council for development of Stem cell sciences & Technologies, Vice presidency for Science an 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 Approved 2016-08-27 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway Tehran Iran (Islamic Republic of)