[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"S&Ebio Co. Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100592607",false,"NCT06995625","The STem Cell-derived Extracellular Vesicle Therapy In Acute Ischemic Stroke (STEVIA)","An Open-Label, Single-Arm, Dose Escalation Phase I Clinical Trial to Evaluate the Safety and Tolerability of SNE-101 in Patients With Acute Ischemic Stroke","STEVIA","Inclusion Criteria:\n\n* Adults with 19 years or older\n* Patients within 5 days of symptom onset who have not received thrombolytic therapy or undergone endovascular reperfusion procedures.\n* 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.\n* Imaging findings must meet both of the following:\n\n  * Infarction within the middle cerebral artery territory on diffusion-weighted imaging (DWI)\n  * Infarct size ≥ 20 mm in the longest diameter on DWI\n* Neurological status meeting all three of the following NIHSS criteria:\n\n  * Moderate to severe neurological deficit (NIHSS score between 5-21)\n  * New onset of motor weakness (score 2-4 in at least one of NIHSS items 5a, 5b, 6a, or 6b)\n  * No impaired consciousness (score 0-1 on NIHSS items 1a, 1b, and 1c)\n* Voluntary written informed consent\n\nExclusion Criteria:\n\nSubjects are ineligible if they meet any of the following:\n\n* Pre-stroke disability (pre-stroke mRS ≥ 2)\n* Likely to recover spontaneously, based on all three of:\n\n  * No longer meeting the NIHSS inclusion criteria 48 hours post-thrombolysis or endovascular therapy\n  * Lacunar stroke due to small vessel occlusion\n  * SAFE (Shoulder Abduction and Finger Extension) score ≥ 5\n* Presence or risk of malignant middle cerebral artery infarction with brain edema\n* Significant medical history within the past 5 years:\n\n  * Severe heart failure\n  * Severe infectious disease\n  * Severe hepatic failure or renal failure\n  * Newly diagnosed or actively treated cancer\n  * Any systemic disease deemed by investigator to significantly reduce life expectancy\n  * Any condition likely to hinder follow-up during the study\n* Diagnosed severe psychiatric illness:\n\n  * Moderate or greater depression pre-stroke with functional impairment and suicide risk\n  * Pre-stroke dementia interfering with daily living (CDR ≥ 2)\n* Contraindication to MRI (e.g., pacemaker)\n* Pregnant or breastfeeding, or unwilling to use effective contraception method for 90 days after last dose.\n* Participation in another clinical trial within the past 3 months\n* Any other reason determined by the investigator that would prevent participation","ALL","19 Years",{"count":19,"type":20},18,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a multicenter open-label, single-arm, dose escalation phase I clinical trial to evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke",[26],"Acute Ischemic Stroke AIS",[28,29,30,31,32],"Stroke","Exosome","Extracellular vesicles","Wharton's jelly-mesenchymal stem cell","MSC","NOT_YET_RECRUITING","2025-07-31",{"date":36,"type":37},"2025-08-01","ACTUAL",{"date":36,"type":20},{"date":40,"type":20},"2027-03-31",{"name":42,"class":43},"S&Ebio Co. Ltd.","INDUSTRY",3,""]