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NCT Number: NCT07144241

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

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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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UNIMUS Hospital

Semarang, Central Java, Indonesia

Location contact

Dr. dr. Yanuar Ardani, M.Kes, Sp.PD, K-PPM, FINASIM

CONTACT

[email protected]

085227700340

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Fasting Blood Glucose (FBG)

    Time frame: 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. 2-Hour Postprandial Glucose

    Time frame: 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

  3. HbA1c

    Time frame: 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: %

  4. C-peptide

    Time frame: 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 outcomes

  1. Quality of Life using DQoL

    Time frame: 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

  2. IL-6

    Time frame: 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

  3. IL-10

    Time frame: 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

  4. D-dimer

    Time frame: 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

  5. CRP

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. dr. Yanuar Ardani, M.Kes, Sp.PD, K-PPM, FINASIM

CONTACT

[email protected]

085227700340

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 27, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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