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

University of Indonesia (UI)

Status and phase: Not yet enrolling; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Biological: Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS + 1 vial Exo-HUVEC) Therapy; Biological: Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS ) Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07144241

YArdani MSC-Exos T2DM

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

Group 1: Intervention Group

Active Comparator group

Description:

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

Treatment:

Biological: Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS + 1 vial Exo-HUVEC) Therapy

Group 2: Control Group

Placebo Comparator group

Description:

Receives standard therapy for DM plus 1 vial of Exo-HWS. Administered as a monthly intravenous bolus injection for three months.

Treatment:

Biological: Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS ) Therapy