[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629253":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":28,"locations":37,"responsibleParty":51,"collaborators":32,"id":53,"slug":32,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":32,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":32,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":32,"overallStatus":71,"whyStopped":32,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Vinmec Research Institute of Stem Cell and Gene Technology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Regimen","EXPERIMENTAL","Participants in this experimental arm will receive intravenous VinEV-3. Premedication with Dimedrol will be administered prior to infusion. VinEV-3 will be diluted in 0.9% sodium chloride to a total volume of 100 mL and infused over approximately 60 minutes. A dose-escalation design will be applied with safety-based dose adjustment. Participants will receive three infusions administered at 30 ± 5 day intervals, while continuing standard-of-care treatment. Patients will be followed for safety and clinical outcomes at 3, 6, and 9 months after the first infusion",[13],"Biological: Umbilical cord mesenchymal stem cell-derived extracellular vesicles",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Umbilical cord mesenchymal stem cell-derived extracellular vesicles","Dimedrol 20 mg will be administered intravenously 15-30 minutes prior to EV infusion. VinEV-3 will be administered at a starting dose of 2 × 10¹⁰ EV particles\u002Fkg, with dose escalation to 4 × 10¹⁰ EV particles\u002Fkg in the absence of dose-limiting toxicity or dose reduction to 1 × 10¹⁰ EV particles\u002Fkg if dose-limiting toxicity occurs. Three infusions will be given at 30 ± 5 day intervals, 3 times, with safety follow-up through 9 months after the first infusion",[9],[21,22],"UC-MSC-EV","VinEV-3",[24],{"name":25,"affiliation":26,"role":27},"Thanh Liem Nguyen","Vinmec Research Institute of Stem Cell and Gene Technology Hanoi, Vietnam 100000","PRINCIPAL_INVESTIGATOR",[29,34],{"name":25,"role":30,"phone":31,"phoneExt":32,"email":33},"CONTACT","(+84) 98 656 50 15",null,"v.liemnt@vinmec.com",{"name":35,"role":30,"phone":36,"phoneExt":32,"email":32},"Van T. Hoang","+84 93 644 94 81",[38],{"facility":5,"status":32,"city":39,"state":32,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Hanoi","100000","Vietnam",{"type":43,"coordinates":44},"Point",[45,46],105.84117,21.0245,{"lat":46,"lon":45},[49],{"name":25,"role":30,"phone":50,"phoneExt":32,"email":33},"+84 4 3974 3556",{"type":52,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100629253",false,"NCT07472270","Safety Evaluation of MSC-based Therapy for Liver Cihcrosis Treatment","Phase 1 Clinical Trial: Evaluation of the Safety and Preliminary Efficacy of Umbilical Cord-Derived Mesenchymal Stem Cell Extracellular Vesicle Therapy in the Treatment of Liver Cirrhosis","Inclusion Criteria:\n\n* Liver cirrhosis due to alcohol-related liver disease or chronic hepatitis B or C\n* Child-Pugh score 7-12\n* Alcohol-related cirrhosis: abstinent from alcohol ≥ 3 months\n* HBV\u002FHCV-related cirrhosis: viral disease controlled according to standard clinical criteria\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Significant renal dysfunction or coagulation abnormalities\n* Liver cirrhosis of unknown etiology\n* Current or suspected hepatocellular carcinoma or history of malignancy\n* Portal vein thrombosis\n* Pregnancy, breastfeeding, or inadequate contraception\n* Severe renal, respiratory, cardiovascular, infectious, autoimmune, metabolic, or neurological disorders that may interfere with study participation\n* Refractory ascites at screening\n* Use of known hepatotoxic medications within a clinically relevant period\n* Coinfection with HIV, tuberculosis, or other causes of chronic liver disease","ALL","18 Years","75 Years",{"count":63,"type":64},12,"ESTIMATED","INTERVENTIONAL",[67],"PHASE1","This study Phase 1 clinical trial aimed to evaluate the safety and preliminary efficacy of intravenously administered extracellular vesicles derived from umbilical cord mesenchymal stem cells (UC-MSC-EVs; VinEV-3) in patients with liver cirrhosis. The trial uses a rolling six dose-escalation design, enrolling up to 12 adult patients (18-75 years) with Child-Pugh scores of 7-12.\n\nThe results of this study are expected to provide initial clinical evidence supporting the safety and potential therapeutic role of UC-MSC-EVs as a novel cell-free treatment approach for liver cirrhosis.",[70],"Liver Cirrhosis","NOT_YET_RECRUITING","2026-03-13",{"date":74,"type":75},"2026-03-16","ACTUAL",{"date":77,"type":64},"2026-03-15",{"date":79,"type":64},"2026-12-31",{"name":5,"class":6},1]