[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604032":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":52,"collaborators":26,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":26,"eligibilityCriteria":61,"healthyVolunteers":58,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":80,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Indonesia University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: Intervention Group","ACTIVE_COMPARATOR","Receives standard therapy for Diabetes Mellitus (DM) plus a combination of exosomes (1 vial Exo-HWS + 1 vial Exo-HUVEC).\n\nAdministered as a monthly intravenous bolus injection for three months",[13],"Biological: Mesenchymal Stromal\u002FStem Cells-Derived Exosomes (Exo-HWS + 1 vial Exo-HUVEC) Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Group 2: Control Group","PLACEBO_COMPARATOR","Receives standard therapy for DM plus 1 vial of Exo-HWS.\n\nAdministered as a monthly intravenous bolus injection for three months.",[19],"Biological: Mesenchymal Stromal\u002FStem Cells-Derived Exosomes (Exo-HWS ) Therapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Mesenchymal Stromal\u002FStem Cells-Derived Exosomes (Exo-HWS + 1 vial Exo-HUVEC) Therapy","The intervention group will receive standard DM therapy plus an exosome combination of 1 vial Exo-HWS + 1 vial Exo-HUVEC, administered monthly for three months via intravenous bolus injection.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Mesenchymal Stromal\u002FStem Cells-Derived Exosomes (Exo-HWS ) Therapy","The control group will receive standard DM therapy plus 1 vial Exo-HWS, administered monthly for three months via intravenous bolus injection.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Dr. dr. Yanuar Ardani, M.Kes, Sp.PD, K-PPM, FINASIM","CONTACT","085227700340","dr.yanuardani@gmail.com",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"UNIMUS Hospital","Semarang","Central Java","Indonesia","ID",{"type":45,"coordinates":46},"Point",[47,48],110.42083,-6.99306,{"lat":48,"lon":47},[51],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Yanuar Ardani","Principal Investigator","100604032","phase-2-mesenchymal-stromalstem-cells-derived-exosomes-msc-exos-therapy-for-type-2-diabetes-mellitus-patients-100604032",false,"NCT07144241","Mesenchymal Stromal\u002FStem Cells-Derived Exosomes (MSC-Exos) Therapy for Type 2 Diabetes Mellitus Patients","Inclusion Criteria:\n\n* Patients diagnosed with Type 2 Diabetes Mellitus.\n* Patients aged 40 to 65 years.\n* Patients who are willing to participate in the study and sign the informed consent form after receiving a detailed explanation of the research procedure.\n\nExclusion Criteria:\n\n* Patients with severe comorbidities that could affect the immune response, such as autoimmune diseases, malignancies, and severe infections.\n* Patients currently undergoing anticoagulant therapy.\n* Patients currently undergoing immunosuppressive therapy.\n* Pregnant women, as the effects of exosome therapy on them have not been sufficiently studied.\n* Patients with a history of severe allergies to components of the exosome therapy.\n* Patients with CKD (Chronic Kidney Disease) on HD (Hemodialysis).","ALL","40 Years","65 Years",{"count":66,"type":67},50,"ESTIMATED","INTERVENTIONAL",[70],"PHASE2","This is an open-label randomized controlled trial with a pre-and-post-test control group design to evaluate the effect of Mesenchymal Stromal\u002FStem Cells-Derived Exosomes (MSC-Exos) as an adjunctive therapy on glycemic control and clinical outcomes in patients with Type 2 Diabetes Mellitus (T2DM). The study aims to determine if the addition of exosome therapy to standard care can improve glycemic parameters (fasting blood glucose, 2-hour postprandial glucose, HbA1c, and C-peptide), quality of life, and inflammatory biomarkers (IL-6, IL-10, D-dimer, and CRP). The study will involve 50 subjects, randomly allocated into two groups: an intervention group and a control group. The intervention group will receive standard T2DM therapy plus a combination of exosomes (1 vial Exo-HWS + 1 vial Exo-HUVEC). The control group will receive standard T2DM therapy plus 1 vial Exo-HWS. The study duration is from June to December 2025.",[73],"Type 2 Diabetes Mellitus",[75,76,77,78,79],"DMT2","Mesenchymal Stromal\u002FStem Cells-Derived Exosomes","Glycemic Profile","Quality of Life","Inflammatory Biomarkers","NOT_YET_RECRUITING","2025-08-20",{"date":83,"type":84},"2025-08-27","ACTUAL",{"date":86,"type":67},"2025-09-01",{"date":88,"type":67},"2026-07-01",{"name":5,"class":6},1]