The Safety and feasibility of Intra-Arterial Stem Cell Therapy In Patients with Sub-Acute Stroke

Phase 1

Recruiting

Conditions: Ischemic stroke.
Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries

Registration Number: IRCT2016051327865N1

Lead Sponsor: Vice Chancellor for Research and Technology, Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 4

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.

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Score of NIHSS scale. Timepoint: On 0, 30th, 90th and 180th days after cell injection. Method of measurement: NIHSS questionnaire (0-42) score.

Secondary Outcome Measures

Name	Time	Method
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.