Clinical Trial

Mesenchymal Stromal/Stem Cells-Derived Exosomes (MSC-Exos) Therapy for Type 2 Diabetes Mellitus Patients

Not Yet Recruiting Phase 2
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Record status
This record was last updated August 27, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
This is an open-label randomized controlled trial with a pre-and-post-test control group design to evaluate the effect of Mesenchymal Stromal/Stem 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.
Trial Details
NCT Number NCT07144241
Lead Sponsor Indonesia University
Conditions Type 2 Diabetes Mellitus
Enrollment 50 participants
Start Date 2025-09-01
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-07-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-27