[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607040":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":41,"locations":52,"responsibleParty":72,"collaborators":74,"id":82,"slug":46,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":46,"studyType":95,"phases":96,"briefSummary":99,"conditions":100,"keywords":106,"overallStatus":54,"whyStopped":46,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Universitas Padjadjaran","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MSC-derived Exosome Therapy","EXPERIMENTAL","Participants receive Intravenous or Intramuscular MSC-derived exosomes.",[13],"Biological: Mesenchymal Stem Cell-Derived Exosomes",{"label":15,"type":16,"description":17,"interventionNames":18},"Saline\u002FPlacebo","PLACEBO_COMPARATOR","Participants receive Intravenous or Intramuscular sterile saline solution",[19],"Other: Placebo (Sterile Saline Solution)",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Mesenchymal Stem Cell-Derived Exosomes","Mesenchymal stem cell-derived exosomes isolated from adipose-derived stem cells (ASC). The exosomes contain bioactive molecules including microRNAs (particularly miR-126-3p), proteins, and lipids that promote endothelial repair and regeneration. The product is manufactured under GMP conditions and administered as a single Intravenous or Intramuscular infusion.",[9],[27,28],"MSC-Exos","Fetal stem cell exosomes",{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Placebo (Sterile Saline Solution)","Sterile saline solution (0.9% sodium chloride) administered Intravenous or Intramuscular as placebo control. The volume and administration method are identical to the active treatment to maintain blinding.",[15],[34,35],"Normal saline","0.9% sodium chloride",[37],{"name":38,"affiliation":39,"role":40},"Akhmad Y Pramatirta, M.D., Ph.D","Dr. Hasan Sadikin Central General Hospital","PRINCIPAL_INVESTIGATOR",[42,48],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Prima N Fauziah, S.Si., M.Si.","CONTACT","+62 85721368609",null,"primanandafauziah@gmail.com",{"name":49,"role":44,"phone":50,"phoneExt":46,"email":51},"Nurul Azizah, S.Tr.Keb.","+62 81312971480","nurul19012@mail.unpad.ac.id",[53],{"facility":39,"status":54,"city":55,"state":56,"zip":57,"country":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Bandung","West Java","40161","Indonesia",{"type":60,"coordinates":61},"Point",[62,63],107.60694,-6.92222,{"lat":63,"lon":62},[66,70],{"name":67,"role":44,"phone":68,"phoneExt":46,"email":69},"Akhmad Y Pramatirta, M.D., Ph.D.","+62 81320403090","akhmad.yogi@unpad.ac.id",{"name":71,"role":40,"phone":46,"phoneExt":46,"email":46},"Akhmad Y. Pramatirta, M.D., PhD",{"type":73,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR",[75,78,80],{"name":76,"class":77},"Dr. Hasan Sadikin General Hospital, Bandung, Indonesia","UNKNOWN",{"name":79,"class":6},"Dr Cipto Mangunkusumo General Hospital",{"name":81,"class":77},"Dr. Sardjito Hospital, Yogyakarta","100607040",false,"NCT07183384","MSC Exosome Therapy for Post-Preeclampsia Endothelial Dysfunction","The Effectiveness of Mesenchymal Stem Cell-Derived Exosome Therapy in Improving Endothelial Dysfunction in Postpartum Mothers With a History of Preeclampsia","EXITPE","Inclusion Criteria:\n\n* Postpartum\n* Confirmed diagnosis of preeclampsia in the last pregnancy\n* Postpartum period of first week and second week\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* History of chronic hypertension prior to pregnancy\n* Major cardiovascular disease history\n* Active systemic infection\n* Endothelial Injury history\n* Active smoking status including vape, alcohol, drug addiction.","FEMALE","18 Years","50 Years",{"count":93,"type":94},80,"ESTIMATED","INTERVENTIONAL",[97,98],"PHASE1","PHASE2","\\---\n\nWhy Is This Study Being Done?\n\nWomen who have preeclampsia during pregnancy face a much higher risk of heart disease later in life. Preeclampsia is a serious pregnancy condition that causes high blood pressure and damages blood vessels. Even after the baby is born, the blood vessels do not fully heal on their own, which can lead to heart problems\u002Fcardiovascular years later.\n\nThis study tests whether a new treatment called exosomes can help repair damaged blood vessels in women who had preeclampsia. Exosomes are tiny particles that come from stem cells and contain healing substances that may help blood vessels work better.\n\n\\---\n\nWhat Will Happen in This Study?\n\nThis study will include 80 women who recently gave birth and had preeclampsia during their pregnancy. Half of the women will receive the exosome treatment through an IV, and half will receive a placebo (a substance with no active treatment).\n\n\\---\n\nWhat Will Participants Need to Do?\n\nParticipants will:\n\n* Have blood tests and other health checks\n* Receive one treatment through an IV\n* Return for follow-up visits at 1 week after treatment\n* Have tests to check how well their blood vessels are working\n\nWho Can Join This Study?\n\nWomen who:\n\n* Recently gave birth (within 1-2 weeks)\n* Had preeclampsia during their last pregnancy\n* Are healthy enough to participate\n* Can give permission to join the study\n\nWhat Are the Possible Benefits and Risks?\n\nThe treatment may help repair blood vessel damage and reduce the risk of future heart disease. The exosome treatment appears to be safe based on other studies, but like any medical treatment, there may be side effects.\n\n\\---\n\nHow Long Will the Study Last?\n\nThe main treatment happens during one visit, with follow-up visits for 1 week to check on participants' health and see if the treatment is working.\n\nThis research may lead to new ways to protect women's heart health after pregnancy complications.",[101,102,103,104,105],"Preeclampsia","Postpartum","Endothelial Injury","Exosome Multiomics","Cell Therapy",[101,102,107,108,105],"Stem Cell","Exosome","2025-09-12",{"date":111,"type":112},"2025-09-19","ACTUAL",{"date":114,"type":112},"2024-07-01",{"date":116,"type":94},"2026-09-01",{"name":5,"class":6},1]