The STem Cell-derived Extracellular Vesicle Therapy In Acute Ischemic Stroke (STEVIA)

Ki vehet részt

• Adults with 19 years or older
• Patients within 5 days of symptom onset who have not received thrombolytic therapy or undergone endovascular reperfusion procedures
• Patients within 5 days of symptom onset who have received thrombolytic therapy or undergone endovascular reperfusion procedures but show no clinical recovery after 2 days of observation
• Imaging findings must meet both of the following:; Infarction within the middle cerebral artery territory on diffusion-weighted imaging (DWI); Infarct size ≥ 20 mm in the longest diameter on DWI
• Neurological status meeting all three of the following NIHSS criteria:; Moderate to severe neurological deficit (NIHSS score between 5-21); New onset of motor weakness (score 2-4 in at least one of NIHSS items 5a, 5b, 6a, or 6b); No impaired consciousness (score 0-1 on NIHSS items 1a, 1b, and 1c)
• Voluntary written informed consent

Ki nem vehet részt

• Pre-stroke disability (pre-stroke mRS ≥ 2)
• Likely to recover spontaneously, based on all three of:; No longer meeting the NIHSS inclusion criteria 48 hours post-thrombolysis or endovascular therapy; Lacunar stroke due to small vessel occlusion; SAFE (Shoulder Abduction and Finger Extension) score ≥ 5
• Presence or risk of malignant middle cerebral artery infarction with brain edema
• Significant medical history within the past 5 years:; Severe heart failure; Severe infectious disease; Severe hepatic failure or renal failure; Newly diagnosed or actively treated cancer; Any systemic disease deemed by investigator to significantly reduce life expectancy; Any condition likely to hinder follow-up during the study
• Diagnosed severe psychiatric illness:; Moderate or greater depression pre-stroke with functional impairment and suicide risk; Pre-stroke dementia interfering with daily living (CDR ≥ 2)
• Subjects are ineligible if they meet any of the following:
• Contraindication to MRI (e.g., pacemaker)
• Pregnant or breastfeeding, or unwilling to use effective contraception method for 90 days after last dose
• Participation in another clinical trial within the past 3 months
• Any other reason determined by the investigator that would prevent participation