[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594384":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":48,"responsibleParty":63,"collaborators":65,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":42,"studyType":82,"phases":83,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":95,"whyStopped":42,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Mahidol University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Wharton's jelly-derived mesenchymal stem cells","EXPERIMENTAL","A total of three IV infusions of MSCs will be administered, one dose per day for three consecutive days, starting within the first 10 days of life, following the completion of TH.",[13],"Biological: Wharton's jelly-derived mesenchymal stem cells",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","A total of three IV infusions of 0.9%NSS will be administered, one dose per day for three consecutive days, starting within the first 10 days of life, following the completion of TH.",[19],"Drug: 0.9 % Normal Saline",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","MSCs (2x10\\^6 cells\u002Fkg) in 10 mL 0.9%normal saline administered intravenously within 10 days, postnatally after TH completion, every 24 hours for 3 consecutive days",[9],[26],"mesenchymal stem cells",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","0.9 % Normal Saline","0.9% normal saline 10 mL administered intravenously within 10 days, postnatally after TH completion, every 24 hours for 3 consecutive days",[15],[33],"0.9%NSS",[35],{"name":36,"affiliation":5,"role":37},"Ratchada Kitsommart, MD","PRINCIPAL_INVESTIGATOR",[39,44],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","66961715544",null,"ratchada.kit@mahidol.ac.th",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Buranee Yangthara, MD, PhD","66843270809","buraneeyangthara@gmail.com",[49],{"facility":50,"status":42,"city":51,"state":42,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Siriraj Hospital, Mahidol University","Bangkok","10700","Thailand","TH",{"type":56,"coordinates":57},"Point",[58,59],100.50144,13.75398,{"lat":59,"lon":58},[62],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},{"type":64,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[66],{"name":67,"class":6},"Siriraj Hospital","100594384","phase-1-mesenchymal-stem-cells-with-cooling-therapy-for-infants-with-hypoxic-ischemic-encephalopathy-100594384",false,"NCT07018739","Mesenchymal Stem Cells With Cooling Therapy for Infants With Hypoxic-Ischemic Encephalopathy","Efficacy of Using Mesenchymal Stem Cells With Therapeutic Hypothermia in Infants With Perinatal Hypoxic-Ischemic Encephalopathy: A Double Blind, Randomized Controlled Trial","SiSTEM-NEO","Inclusion Criteria:\n\n* Term and late-preterm infants (gestational age ≥34 weeks)\n* Diagnosed with moderate to severe HIE based on modified Sarnat staging\n* Received TH per standard protocol\n* Parental consent obtained\n\nExclusion Criteria:\n\n* Major congenital anomalies or genetic syndromes\n* Severe sepsis or active infection\n* Severe coagulopathy or bleeding disorders\n* Multi-organ failure","ALL","4 Days","9 Days",{"count":80,"type":81},40,"ESTIMATED","INTERVENTIONAL",[84,85],"PHASE1","PHASE2","Hypoxic-ischemic encephalopathy (HIE) is a serious condition in newborns caused by lack of oxygen and blood flow around the time of birth. Standard treatment with cooling therapy (therapeutic hypothermia) lowers the risk of death or disability, but many infants still suffer long-term problems.\n\nThis study will test whether adding stem cell therapy after cooling can further improve outcomes. The stem cells are taken from donated human placentas (Wharton's jelly-derived mesenchymal stem cells, MSCs). The cells are prepared under strict laboratory standards and checked for safety.\n\nInfants with moderate to severe HIE who have completed cooling will be randomly assigned to receive either three intravenous infusions of MSCs or placebo within the first 10 days of life. Each infusion is given over about 30 minutes while the infant is closely monitored.\n\nResearchers will follow participants for up to 2 years. The main outcome is whether MSC treatment can reduce the combined risk of death or serious developmental delay at 1 year of age. The study will also track brain MRI findings, safety events, and developmental progress at 2 years.",[88,89],"Hypoxic-Ischemic Encephalopathy, Neonatal","Brain Injuries, Hypoxic-Ischemic",[91,92,93,94],"Perinatal HIE","Mesenchymal stem cells","Wharton's jelly","therapeutic hypothermia","NOT_YET_RECRUITING","2025-11-15",{"date":98,"type":99},"2025-11-19","ACTUAL",{"date":101,"type":81},"2026-06",{"date":103,"type":81},"2033-12",{"name":5,"class":6},1]