[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592607":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":30,"responsibleParty":75,"collaborators":19,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":19,"enrollmentInfo":87,"targetDuration":19,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":102,"whyStopped":19,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"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",[31,47,66],{"facility":32,"status":19,"city":33,"state":34,"zip":35,"country":36,"countryCode":19,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Ajou University Hospital","Suwon","Gyeonggi-do","16499","South Korea",{"type":38,"coordinates":39},"Point",[40,41],127.00889,37.29111,{"lat":41,"lon":40},[44],{"name":45,"role":46,"phone":19,"phoneExt":19,"email":19},"Jin soo Lee, MD","PRINCIPAL_INVESTIGATOR",{"facility":48,"status":19,"city":49,"state":19,"zip":50,"country":36,"countryCode":19,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Samsung Medical Center","Seoul","06351",{"type":38,"coordinates":52},[53,54],126.9784,37.566,{"lat":54,"lon":53},[57,60,62,64],{"name":58,"role":59,"phone":19,"phoneExt":19,"email":19},"Woo-Keun Seo, MD","SUB_INVESTIGATOR",{"name":61,"role":59,"phone":19,"phoneExt":19,"email":19},"Jong-Won Chung, MD",{"name":63,"role":59,"phone":19,"phoneExt":19,"email":19},"Hyung Jun Kim, MD",{"name":65,"role":59,"phone":19,"phoneExt":19,"email":19},"Won Hyuk Chang, MD",{"facility":67,"status":19,"city":49,"state":19,"zip":68,"country":36,"countryCode":19,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"Ewha Womans University Seoul Hospital","07804",{"type":38,"coordinates":70},[53,54],{"lat":54,"lon":53},[73],{"name":74,"role":59,"phone":19,"phoneExt":19,"email":19},"Tae-Jin Song, MD",{"type":76,"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":88,"type":89},18,"ESTIMATED","INTERVENTIONAL",[92],"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",[95],"Acute Ischemic Stroke AIS",[97,98,99,100,101],"Stroke","Exosome","Extracellular vesicles","Wharton's jelly-mesenchymal stem cell","MSC","NOT_YET_RECRUITING","2025-07-31",{"date":105,"type":106},"2025-08-01","ACTUAL",{"date":105,"type":89},{"date":109,"type":89},"2027-03-31",{"name":5,"class":6},3]