Exosome in acute ischemic stroke
Phase 1
- Conditions
- Cerebral infarction.Cerebral infarction
- Registration Number
- IRCT20200502047277N9
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
Age between 18 and 80 years
Diagnosis of acute ischemic stroke based on clinical and imaging evidence within 24 to 72 h after the onset
Baseline National Institutes of Health Stroke Scale (NIHSS) score between 6 and 20
Exclusion Criteria
Diagnosis of lacunar or brainstem stroke
Acute intracranial hemorrhage
History of seizure or current therapy with anti-epileptic medications
Any history of traumatic brain injury
Any uncontrolled comorbidity, such as diabetes, hepatic, renal, or cardiac failure
Ischemic stroke or myocardial infarction within the last 6 months
Abnormal renal, hepatic, immunologic, and coagulation profiles
Pregnancy and lactation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety profile of the study intervention. Timepoint: Daily during the first 7 days after the injection and weekly until 3-month after the injection. Method of measurement: Monitoring and evaluating the patients regarding the adverse events.
- Secondary Outcome Measures
Name Time Method ational Institutes of Health Stroke Scale (NIHSS). Timepoint: 1-, 3-, and 6-month after the injection. Method of measurement: Physical examination.;Modified Rankin scale (mRS). Timepoint: 1-, 3-, and 6-month after the injection. Method of measurement: Evaluation of patient.