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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Intervention Group | Active Comparator | 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 |
|
| Group 2: Control Group | Placebo Comparator | Receives standard therapy for DM plus 1 vial of Exo-HWS. Administered as a monthly intravenous bolus injection for three months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS + 1 vial Exo-HUVEC) Therapy | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Blood Glucose (FBG) | Change in FBG levels from baseline to the end of the third month. Unit of Measurement: mg/dL | 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 | 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: % | 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 | Baseline (Day 0) and End of the 3rd Month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline (Day 0) and End of the 3rd Month |
| IL-6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. dr. Yanuar Ardani, M.Kes, Sp.PD, K-PPM, FINASIM | Contact | 085227700340 | dr.yanuardani@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNIMUS Hospital | Semarang | Central Java | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34614408 | Background | Li CJ, Xiao Y, Sun YC, He WZ, Liu L, Huang M, He C, Huang M, Chen KX, Hou J, Feng X, Su T, Guo Q, Huang Y, Peng H, Yang M, Liu GH, Luo XH. Senescent immune cells release grancalcin to promote skeletal aging. Cell Metab. 2021 Oct 5;33(10):1957-1973.e6. doi: 10.1016/j.cmet.2021.08.009. Epub 2021 Sep 9. | |
| 32029601 | Background |
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There is no explicit plan to share Individual Participant Data (IPD) from this study. The research team's commitment to participant confidentiality is paramount. The informed consent form assures participants that their data and information will be kept confidential and will be used solely for the purpose of the research, education, and scientific development, without disclosing their identity. This approach aligns with the ethical clearance obtained for the study, which emphasizes protecting participant identity.
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open-label randomized controlled trial with a pre-and-post-test control group design. The study aims to compare the effectiveness of Mesenchymal Stromal/Stem Cells-Derived Exosomes (MSC-Exos) as an additional therapy for patients with Type 2 Diabetes Mellitus (T2DM).
The study will recruit 50 subjects who meet the inclusion and exclusion criteria. These subjects will be randomly assigned to one of two groups Intervention Group: This group will receive standard T2DM therapy along with a combination of exosomes, specifically 1 vial of Exo-HWS and 1 vial of Exo-HUVEC. The exosome therapy will be administered as an intravenous bolus injection monthly, for three months.
Control Group: This group will receive standard T2DM therapy plus 1 vial of Exo-HWS. This therapy will also be administered monthly, for three months, via intravenous bolus injection.
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|
| Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS ) Therapy | Biological | The control group will receive standard DM therapy plus 1 vial Exo-HWS, administered monthly for three months via intravenous bolus injection. |
|
Change in Interleukin-6 (IL-6) levels from baseline to the end of the third month.
Unit of Measurement: mg/L
| 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 | 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 | 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 | Baseline (Day 0) and End of the 3rd Month |
| Kalluri R, LeBleu VS. The biology, function, and biomedical applications of exosomes. Science. 2020 Feb 7;367(6478):eaau6977. doi: 10.1126/science.aau6977. |
| 25765629 | Background | Lai RC, Yeo RW, Lim SK. Mesenchymal stem cell exosomes. Semin Cell Dev Biol. 2015 Apr;40:82-8. doi: 10.1016/j.semcdb.2015.03.001. Epub 2015 Mar 9. |
| 23420871 | Background | Raposo G, Stoorvogel W. Extracellular vesicles: exosomes, microvesicles, and friends. J Cell Biol. 2013 Feb 18;200(4):373-83. doi: 10.1083/jcb.201211138. |
| 33551551 | Background | American Diabetes Association. Standards of Medical Care in Diabetes-2021 Abridged for Primary Care Providers. Clin Diabetes. 2021 Jan;39(1):14-43. doi: 10.2337/cd21-as01. No abstract available. |
| 32061820 | Background | Williams R, Karuranga S, Malanda B, Saeedi P, Basit A, Besancon S, Bommer C, Esteghamati A, Ogurtsova K, Zhang P, Colagiuri S. Global and regional estimates and projections of diabetes-related health expenditure: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2020 Apr;162:108072. doi: 10.1016/j.diabres.2020.108072. Epub 2020 Feb 13. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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