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.
Patients diagnosed with Type 2 Diabetes Mellitus.
Patients aged 40 to 65 years.
Patients who are willing to participate in the study and sign the informed consent form after receiving a detailed explanation of the research procedure.
Patients with severe comorbidities that could affect the immune response, such as autoimmune diseases, malignancies, and severe infections.
Patients currently undergoing anticoagulant therapy.
Patients currently undergoing immunosuppressive therapy.
Pregnant women, as the effects of exosome therapy on them have not been sufficiently studied.
Parallel
Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS + 1 vial Exo-HUVEC) Therapy
Biological/VaccineThe 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.
Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS ) Therapy
Biological/VaccineThe control group will receive standard DM therapy plus 1 vial Exo-HWS, administered monthly for three months via intravenous bolus injection.
Fasting Blood Glucose (FBG)
Change in FBG levels from baseline to the end of the third month. Unit of Measurement: mg/dL
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
HbA1c
Change in HbA1c levels from baseline to the end of the third month. Unit of Measurement: %
C-peptide
Change in C-peptide levels from baseline to the end of the third month. Unit of Measurement: ng/m
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
IL-6
Change in Interleukin-6 (IL-6) levels from baseline to the end of the third month. Unit of Measurement: mg/L
IL-10
Change in Interleukin-10 (IL-10) levels from baseline to the end of the third month. Unit of Measurement: mg/L
D-dimer
Change in D-dimer levels from baseline to the end of the third month. Unit of Measurement: ng/mL
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