Acute ischemic stroke, also known as cerebral infarction, is a neurological disorder caused by the sudden blockage of a cerebral blood vessel, leading to ischemia, hypoxia, and subsequent necrosis of brain tissue. It is the most common type of stroke, accounting for approximately 75% to 80% of all cases. Characterized by high incidence, high disability rate, and high mortality, it is one of the le
Conditions
Interventions
Single-dose Study - Dose Group 1:Standard treatment + exosome therapy (2×10^9/ml), nasal spray 0.5ml per nostril once daily, Day 1
Single-dose Study - Dose Group 2:Standard treatment + exosome therapy (4×10^9/ml), nasal spray 0.5ml per nostril once daily, Day 1
Single-dose Study - Dose Group 3:Standard treatment + exosome therapy (8×10^9/ml), nasal spray 0.5ml per nostril once daily, Day 1
Multiple-dose Study - Low-dose Control Group:Standard treatment + placebo (normal saline), nasal spray 0.5ml per nostril once daily, Days 1–14
Multiple-dose Study - Low-dose Experimental Group:Standard treatment + exosome therapy (X×10^9/ml), nasal spray 0.5ml per nostril once daily, Days 1–14
Multiple-dose Study - High-dose Control Group:Standard treatment + placebo (normal saline), nasal spray 0.5ml per nostril once daily, Days 1–14
Multiple-dose Study - High-dose Experimental Group:Standard treatment + exosome therapy (Y×10^9/ml), nasal spray 0.5ml per nostril once daily, Days 1–14
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years, male or female; 2. Patients with acute ischemic stroke within 72 hours of symptom onset; 3. Internal carotid artery system stroke; 4. For the single-dose study: mild stroke patients (NIHSS score 1-4, inclusive of 1 and 4); 5. For the multiple-dose study: moderate stroke patients (NIHSS score 5-12, inclusive of 5 and 12); 6. Pre-stroke mRS score <= 1; 7. Subjects or their guardians voluntarily sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1. Moderate to severe stroke (NIHSS score > 12); 2. Lacunar infarction or brainstem/cerebellar infarction (confirmed by DWI-MRI); 3. Requires endovascular intervention for this acute event; 4. Intracranial hemorrhagic disease (including intraparenchymal, intraventricular, or subarachnoid hemorrhage); 5. Patients with malignant tumors; 6. Patients with severe traumatic brain injury; 7. Patients with primary or secondary immunodeficiency or on immunosuppressive therapy; 8. Serum ALT or AST levels >= 3x upper limit of normal; 9. Chronic kidney disease, or serum creatinine >= 1.5x upper limit of normal, or eGFR < 60 mL/min/1.73m^2; 10. Concurrent severe infection with fever, or severe respiratory disease; 11. HBsAg positive; or HBcAb positive with detectable HBV-DNA; or positive for HCVAb, TPAb/RPR, or HIV antibody; 12. Pregnant or lactating at screening, or planning pregnancy during the study; 13. Allergic to this product or with a history of severe allergy; 14. Investigator-deemed unsuitable for participation or at increased risk due to study participation; 15. Participated in a clinical trial within the past 3 months; 16. Previously received exosome therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, severity, and causality of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), as well as changes in nasal mucosa, pulmonary function, and immunoglobulin levels.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Neurological Function Assessments: National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (mRS), and Activities of Daily Living (Barthel Index, BI).;Changes in Neurological Function Assessments at the First Dose Administration (Day 14): National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (mRS), and Activities of Daily Living;MRI Changes in Cerebral Infarction Lesions.; | — |
Countries
China
Contacts
Public ContactWU YUNCHENG
Shanghai General Hospital
Outcome results
None listed