[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592607":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":30,"responsibleParty":76,"collaborators":19,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":19,"enrollmentInfo":88,"targetDuration":19,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"S&Ebio Co. Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SNE-101","EXPERIMENTAL","Patients will be given SNE-101, an extracellular vesicle derived from Wharton's jelly mesenchymal stem cells.\n\n• Drug: SNE-101\n\n* Three multiple doses of SNE-101 will be administered to three study cohorts , each consisting of 3 to 6 subjects.\n* SNE-101 will be administered intravenously once a day for 5 days.",[13],"Drug: SNE-101",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Experimental: Cohort 1 - SNE-101 4.8 × 10e10 particles (n=3 to 6) Experimental: Cohort 2 - SNE-101 9.6 × 10e10 particles (n=3 to 6) Experimental: Cohort 3 - SNE-101 19.2 × 10e10 particles (n=3 to 6)",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Oh Young Bang, MD, Ph.D","CONTACT","+82-2-2054-8128","ohyoung.bang@snebio.com",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},"SeungWoo Yeon, Ph.D","+82-2-2054-8109","swyeon@snebio.com",[31,48,67],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":19,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Ajou University Hospital","RECRUITING","Suwon","Gyeonggi-do","16499","South Korea",{"type":39,"coordinates":40},"Point",[41,42],127.00889,37.29111,{"lat":42,"lon":41},[45],{"name":46,"role":47,"phone":19,"phoneExt":19,"email":19},"Jin soo Lee, MD","PRINCIPAL_INVESTIGATOR",{"facility":49,"status":33,"city":50,"state":19,"zip":51,"country":37,"countryCode":19,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Samsung Medical Center","Seoul","06351",{"type":39,"coordinates":53},[54,55],126.9784,37.566,{"lat":55,"lon":54},[58,61,63,65],{"name":59,"role":60,"phone":19,"phoneExt":19,"email":19},"Woo-Keun Seo, MD","SUB_INVESTIGATOR",{"name":62,"role":60,"phone":19,"phoneExt":19,"email":19},"Jong-Won Chung, MD",{"name":64,"role":60,"phone":19,"phoneExt":19,"email":19},"Hyung Jun Kim, MD",{"name":66,"role":60,"phone":19,"phoneExt":19,"email":19},"Won Hyuk Chang, MD",{"facility":68,"status":33,"city":50,"state":19,"zip":69,"country":37,"countryCode":19,"cosmosGeoPoint":70,"geoPoint":72,"contacts":73},"Ewha Womans University Seoul Hospital","07804",{"type":39,"coordinates":71},[54,55],{"lat":55,"lon":54},[74],{"name":75,"role":60,"phone":19,"phoneExt":19,"email":19},"Tae-Jin Song, MD",{"type":77,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","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":89,"type":90},18,"ESTIMATED","INTERVENTIONAL",[93],"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",[96],"Acute Ischemic Stroke AIS",[98,99,100,101,102],"Stroke","Exosome","Extracellular vesicles","Wharton's jelly-mesenchymal stem cell","MSC","2026-07-01",{"date":105,"type":106},"2026-07-06","ACTUAL",{"date":108,"type":106},"2026-06-22",{"date":110,"type":90},"2027-03-31",{"name":5,"class":6},3]