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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
The control group will receive standard DM therapy plus 1 vial Exo-HWS, administered monthly for three months via intravenous bolus injection.
UNIMUS Hospital
Semarang, Central Java, Indonesia
Fasting Blood Glucose (FBG)
Change in FBG levels from baseline to the end of the third month. Unit of Measurement: mg/dL
Time frame: Baseline (Day 0) and End of the 3rd Month
2-Hour Postprandial Glucose
Change in 2-hour postprandial glucose levels from baseline to the end of the third month. Unit of Measurement: mg/dL
Time frame: Baseline (Day 0) and End of the 3rd Month
HbA1c
Change in HbA1c levels from baseline to the end of the third month. Unit of Measurement: %
Time frame: Baseline (Day 0) and End of the 3rd Month
C-peptide
Change in C-peptide levels from baseline to the end of the third month. Unit of Measurement: ng/m
Time frame: Baseline (Day 0) and End of the 3rd Month
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. Unit of Measurement: Score
Time frame: Baseline (Day 0) and End of the 3rd Month
IL-6
Change in Interleukin-6 (IL-6) levels from baseline to the end of the third month. Unit of Measurement: mg/L
Time frame: Baseline (Day 0) and End of the 3rd Month
IL-10
Change in Interleukin-10 (IL-10) levels from baseline to the end of the third month. Unit of Measurement: mg/L
Time frame: Baseline (Day 0) and End of the 3rd Month
D-dimer
Change in D-dimer levels from baseline to the end of the third month. Unit of Measurement: ng/mL
Time frame: Baseline (Day 0) and End of the 3rd Month
CRP
Change in C-Reactive Protein (CRP) levels from baseline to the end of the third month. Unit of Measurement: mg/L
Time frame: Baseline (Day 0) and End of the 3rd Month
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