[{"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:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100592607","phase-1-the-stem-cell-derived-extracellular-vesicle-therapy-in-acute-ischemic-stroke-stevia-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":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24],"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",[27],"Acute Ischemic Stroke AIS",[29,30,31,32,33],"Stroke","Exosome","Extracellular vesicles","Wharton's jelly-mesenchymal stem cell","MSC","NOT_YET_RECRUITING","2025-07-31",{"date":37,"type":38},"2025-08-01","ACTUAL",{"date":37,"type":21},{"date":41,"type":21},"2027-03-31",{"name":43,"class":44},"S&Ebio Co. Ltd.","INDUSTRY",3,""]