Mesenchymal Stromal/Stem Cells-Derived Exosomes (MSC-Exos) Therapy for Type 2 Diabetes Mellitus Patients
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Fasting Blood Glucose (FBG)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Patients with a history of severe allergies to components of the exosome therapy.
- •Patients with CKD (Chronic Kidney Disease) on HD (Hemodialysis).
研究组 & 干预措施
Group 1: Intervention Group
Receives standard therapy for Diabetes Mellitus (DM) plus a combination of exosomes (1 vial Exo-HWS + 1 vial Exo-HUVEC).
Administered as a monthly intravenous bolus injection for three months
干预措施: Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS + 1 vial Exo-HUVEC) Therapy (Biological)
Group 2: Control Group
Receives standard therapy for DM plus 1 vial of Exo-HWS.
Administered as a monthly intravenous bolus injection for three months.
干预措施: Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS ) Therapy (Biological)
结局指标
主要结局
Fasting Blood Glucose (FBG)
时间窗: Baseline (Day 0) and End of the 3rd Month
Change in FBG levels from baseline to the end of the third month. Unit of Measurement: mg/dL
2-Hour Postprandial Glucose
时间窗: Baseline (Day 0) and End of the 3rd Month
Change in 2-hour postprandial glucose levels from baseline to the end of the third month. Unit of Measurement: mg/dL
HbA1c
时间窗: Baseline (Day 0) and End of the 3rd Month
Change in HbA1c levels from baseline to the end of the third month. Unit of Measurement: %
C-peptide
时间窗: Baseline (Day 0) and End of the 3rd Month
Change in C-peptide levels from baseline to the end of the third month. Unit of Measurement: ng/m
次要结局
- Quality of Life using DQoL(Baseline (Day 0) and End of the 3rd Month)
- IL-6(Baseline (Day 0) and End of the 3rd Month)
- IL-10(Baseline (Day 0) and End of the 3rd Month)
- D-dimer(Baseline (Day 0) and End of the 3rd Month)
- CRP(Baseline (Day 0) and End of the 3rd Month)
研究者
Yanuar Ardani
Principal Investigator
Indonesia University