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

August 20, 2025 updated by: Yanuar Ardani, Indonesia University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dr. dr. Yanuar Ardani, M.Kes, Sp.PD, K-PPM, FINASIM
  • Phone Number: 085227700340
  • Email: dr.yanuardani@gmail.com

Study Locations

  • Indonesia
    • Central Java
      • Semarang, Central Java, Indonesia
        • UNIMUS Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1: Intervention Group

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
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.
Placebo Comparator: Group 2: Control Group

Receives standard therapy for DM plus 1 vial of Exo-HWS.

Administered as a monthly intravenous bolus injection for three months.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline (Day 0) and End of the 3rd Month
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
Baseline (Day 0) and End of the 3rd Month
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: %
Baseline (Day 0) and End of the 3rd Month
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
Baseline (Day 0) and End of the 3rd Month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline (Day 0) and End of the 3rd Month
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
Baseline (Day 0) and End of the 3rd Month
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
Baseline (Day 0) and End of the 3rd Month
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
Baseline (Day 0) and End of the 3rd Month
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
Baseline (Day 0) and End of the 3rd Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

August 20, 2025

First Submitted That Met QC Criteria

August 20, 2025

First Posted (Estimated)

August 27, 2025

Study Record Updates

Last Update Posted (Estimated)

August 27, 2025

Last Update Submitted That Met QC Criteria

August 20, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YArdani MSC-Exos T2DM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no explicit plan to share Individual Participant Data (IPD) from this study. The research team's commitment to participant confidentiality is paramount. The informed consent form assures participants that their data and information will be kept confidential and will be used solely for the purpose of the research, education, and scientific development, without disclosing their identity. This approach aligns with the ethical clearance obtained for the study, which emphasizes protecting participant identity.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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