Mesenchymal Stromal/Stem Cells-Derived Exosomes (MSC-Exos) Therapy for Type 2 Diabetes Mellitus Patients

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Biological: Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS + 1 vial Exo-HUVEC) Therapy; Biological: Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS ) Therapy

• Registration Number: NCT07144241
• Lead Sponsor: Indonesia University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-20
• Study First Submitted QC: 2025-08-20
• Last Update Submitted: 2025-08-20
• Study First Posted: 2025-08-27
• Last Update Posted: 2025-08-27
• Study Start: 2025-09-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Intervention Group	Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS + 1 vial Exo-HUVEC) Therapy	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	Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS ) Therapy	Receives standard therapy for DM plus 1 vial of Exo-HWS. Administered as a monthly intravenous bolus injection for three months.

Primary Outcome Measures

Name	Time	Method
Fasting Blood Glucose (FBG)	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	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	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	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

Secondary Outcome Measures

Name	Time	Method
Quality of Life using DQoL	Baseline (Day 0) and End of the 3rd Month	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	Baseline (Day 0) and End of the 3rd Month	Change in Interleukin-6 (IL-6) levels from baseline to the end of the third month.; Unit of Measurement: mg/L
IL-10	Baseline (Day 0) and End of the 3rd Month	Change in Interleukin-10 (IL-10) levels from baseline to the end of the third month.; Unit of Measurement: mg/L
D-dimer	Baseline (Day 0) and End of the 3rd Month	Change in D-dimer levels from baseline to the end of the third month. Unit of Measurement: ng/mL
CRP	Baseline (Day 0) and End of the 3rd Month	Change in C-Reactive Protein (CRP) levels from baseline to the end of the third month.; Unit of Measurement: mg/L

Trial Locations

Locations (1)

UNIMUS Hospital; 🇮🇩 Semarang, Central Java, Indonesia