[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604032":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":38,"studyPopulation":38,"armGroups":46,"interventions":59,"overallOfficials":38,"centralContacts":69,"locations":75,"responsibleParty":90,"collaborators":38,"id":94,"slug":38,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":38,"eligibilityCriteria":98,"healthyVolunteers":95,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":38,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":117,"whyStopped":38,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Indonesia University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":38},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Fasting Blood Glucose (FBG)","Change in FBG levels from baseline to the end of the third month. Unit of Measurement: mg\u002FdL","Baseline (Day 0) and End of the 3rd Month",{"measure":14,"description":15,"timeFrame":12},"2-Hour Postprandial Glucose","Change in 2-hour postprandial glucose levels from baseline to the end of the third month.\n\nUnit of Measurement: mg\u002FdL",{"measure":17,"description":18,"timeFrame":12},"HbA1c","Change in HbA1c levels from baseline to the end of the third month. Unit of Measurement: %",{"measure":20,"description":21,"timeFrame":12},"C-peptide","Change in C-peptide levels from baseline to the end of the third month. Unit of Measurement: ng\u002Fm",[23,26,29,32,35],{"measure":24,"description":25,"timeFrame":12},"Quality of Life using DQoL","Change in quality of life scores as measured by the Diabetes Quality of Life (DQoL) questionnaire from baseline to the end of the third month.\n\nUnit of Measurement: Score",{"measure":27,"description":28,"timeFrame":12},"IL-6","Change in Interleukin-6 (IL-6) levels from baseline to the end of the third month.\n\nUnit of Measurement: mg\u002FL",{"measure":30,"description":31,"timeFrame":12},"IL-10","Change in Interleukin-10 (IL-10) levels from baseline to the end of the third month.\n\nUnit of Measurement: mg\u002FL",{"measure":33,"description":34,"timeFrame":12},"D-dimer","Change in D-dimer levels from baseline to the end of the third month. Unit of Measurement: ng\u002FmL",{"measure":36,"description":37,"timeFrame":12},"CRP","Change in C-Reactive Protein (CRP) levels from baseline to the end of the third month.\n\nUnit of Measurement: mg\u002FL",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":38,"timePerspective":38,"maskingInfo":44},"RANDOMIZED","PARALLEL","open-label randomized controlled trial with a pre-and-post-test control group design. The study aims to compare the effectiveness of Mesenchymal Stromal\u002FStem Cells-Derived Exosomes (MSC-Exos) as an additional therapy for patients with Type 2 Diabetes Mellitus (T2DM).\n\nThe study will recruit 50 subjects who meet the inclusion and exclusion criteria. These subjects will be randomly assigned to one of two groups Intervention Group: This group will receive standard T2DM therapy along with a combination of exosomes, specifically 1 vial of Exo-HWS and 1 vial of Exo-HUVEC. The exosome therapy will be administered as an intravenous bolus injection monthly, for three months.\n\nControl Group: This group will receive standard T2DM therapy plus 1 vial of Exo-HWS. This therapy will also be administered monthly, for three months, via intravenous bolus injection.","TREATMENT",{"masking":45,"maskingDescription":38,"whoMasked":38},"NONE",[47,53],{"label":48,"type":49,"description":50,"interventionNames":51},"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",[52],"Biological: Mesenchymal Stromal\u002FStem Cells-Derived Exosomes (Exo-HWS + 1 vial Exo-HUVEC) Therapy",{"label":54,"type":55,"description":56,"interventionNames":57},"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.",[58],"Biological: Mesenchymal Stromal\u002FStem Cells-Derived Exosomes (Exo-HWS ) Therapy",[60,65],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":38},"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.",[48],{"type":61,"name":66,"description":67,"armGroupLabels":68,"otherNames":38},"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.",[54],[70],{"name":71,"role":72,"phone":73,"phoneExt":38,"email":74},"Dr. dr. Yanuar Ardani, M.Kes, Sp.PD, K-PPM, FINASIM","CONTACT","085227700340","dr.yanuardani@gmail.com",[76],{"facility":77,"status":38,"city":78,"state":79,"zip":38,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"UNIMUS Hospital","Semarang","Central Java","Indonesia","ID",{"type":83,"coordinates":84},"Point",[85,86],110.42083,-6.99306,{"lat":86,"lon":85},[89],{"name":71,"role":72,"phone":73,"phoneExt":38,"email":74},{"type":91,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"PRINCIPAL_INVESTIGATOR","Yanuar Ardani","Principal Investigator","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":103,"type":104},50,"ESTIMATED","INTERVENTIONAL",[107],"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.",[110],"Type 2 Diabetes Mellitus",[112,113,114,115,116],"DMT2","Mesenchymal Stromal\u002FStem Cells-Derived Exosomes","Glycemic Profile","Quality of Life","Inflammatory Biomarkers","NOT_YET_RECRUITING","2025-08-20",{"date":120,"type":121},"2025-08-27","ACTUAL",{"date":123,"type":104},"2025-09-01",{"date":125,"type":104},"2026-07-01",{"name":5,"class":6},1]