Trials / Not Yet Recruiting
Not Yet RecruitingNCT07144241
Mesenchymal Stromal/Stem Cells-Derived Exosomes (MSC-Exos) Therapy for Type 2 Diabetes Mellitus Patients
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Indonesia University · Academic / Other
- Sex
- All
- Age
- 40 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS + 1 vial Exo-HUVEC) Therapy | 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. |
| BIOLOGICAL | Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS ) Therapy | The control group will receive standard DM therapy plus 1 vial Exo-HWS, administered monthly for three months via intravenous bolus injection. |
Timeline
- Start date
- 2025-09-01
- Primary completion
- 2025-12-31
- Completion
- 2026-07-01
- First posted
- 2025-08-27
- Last updated
- 2025-08-27
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT07144241. Inclusion in this directory is not an endorsement.