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Exosome Therapy for Type 2 Diabetes Mellitus Patients

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What is being tested

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

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

Biological
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 40 to 65 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorIndonesia University
Study ContactDr. dr. Yanuar Ardani, M.Kes, Sp.PD, K-PPM, FINASIM
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2025

Actual date on which the first participant was enrolled.

This clinical trial is exploring a new treatment option for people with Type 2 Diabetes Mellitus (T2DM). It aims to see if adding Mesenchymal Stromal/Stem Cells-Derived Exosomes (MSC-Exos) to the usual diabetes care can help better control blood sugar levels and improve overall health outcomes. This study is important because managing blood sugar effectively can reduce complications and improve quality of life for diabetes patients. The trial involves 50 participants with T2DM, who will be divided into two groups. The goal is to find out if this new therapy can enhance glycemic control and reduce inflammation compared to standard treatment alone. Participants in this study will receive either the standard diabetes treatment with additional exosomes or the standard treatment with a different combination of exosomes. The exosomes are given in vials, and the study lasts from June to December 2025. Researchers will measure fasting blood sugar, blood sugar after meals, HbA1c, C-peptide levels, and inflammatory markers like IL-6, IL-10, D-dimer, and CRP to see the effects of the treatment. This study could potentially offer a new way to manage Type 2 Diabetes more effectively.

Official TitleMesenchymal Stromal/Stem Cells-Derived Exosomes (MSC-Exos) Therapy for Type 2 Diabetes Mellitus Patients
NCT07144241
Principal SponsorIndonesia University
Study ContactDr. dr. Yanuar Ardani, M.Kes, Sp.PD, K-PPM, FINASIM
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

3 inclusion criteria required to participate
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.
6 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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 II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

UNIMUS Hospital

Semarang, IndonesiaOpen UNIMUS Hospital in Google Maps
Recruiting soonOne Study Center