Exploratory Study of Intranasal Administration of Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles for the Treatment of Ischemic Stroke

Ki vehet részt

• Ischemic Stroke
• Age 18-70 years, no gender restriction
• Confirmed anterior circulation occlusion by CTA or MR angiography (MRA)
• Pre-stroke mRS score of 0-1
• Post-stroke ASPECTS score >= 6
• Pre-enrollment NIHSS score>= 6
• Within 24 hours to 14 days of stroke onset
• Patients who have not received thrombolysis or endovascular treatment
• No significant liver or kidney dysfunction: ALT and AST<= 2.5 times the upper limit of normal, serum creatinine and blood urea nitrogen <= 1.25 times the upper limit of normal
• No significant cardiac dysfunction
• The subject or legal representative can sign the informed consent form and comply with the requirements of the study for administration and follow-up

Ki nem vehet részt

• Patients with severe local infection, systemic infection, immunodeficiency, or those currently taking immunosuppressants
• Intracranial hemorrhagic conditions observed on cranial CT: hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, or hemorrhagic transformation, etc
• Known severe allergy to contrast agents (excluding mild rash-type allergies)
• Patients with brain tumors, or a history of epilepsy and severe head trauma
• Patients with other systemic malignancies
• Patients with other serious systemic diseases such as immunodeficiency, coagulation disorders, etc
• Patients with Alzheimer's disease, Parkinson's disease, or other neurodegenerative diseases that prevent them from completing follow-up
• Patients who are positive for hepatitis B surface antigen or currently suffering from other infectious diseases
• Patients who have allergic reactions to the drug used in this study or similar drugs
• Patients with known allergic constitution
• Patients clearly lacking the compliance to complete the clinical trial, such as those suffering from uncontrolled mental illness
• Known bleeding tendencies (including but not limited to): platelet count < 100×10\^9/L; received heparin treatment within 48 hours with aPTT >= 35s; currently taking warfarin with INR > 1.7
• Patients with nasal structural abnormalities or lesions
• Patients with cerebrospinal fluid rhinorrhea
• Patients who have participated in other clinical trials within the past 3 months
• Unwilling or unable to comply with the procedures specified in the protocol
• Pregnant or breastfeeding women, or women of childbearing potential who are unwilling or unable to use appropriate contraceptive measures
• Other situations deemed unsuitable for enrollment by the researchers