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.