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

NCT07144241 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: YArdani MSC-Exos T2DM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

DMT2; Mesenchymal Stromal/Stem Cells-Derived Exosomes; Glycemic Profile; Quality of Life; Inflammatory Biomarkers

Outcome Measures

Primary Outcomes (4)

• Fasting Blood Glucose (FBG)

  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

  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

  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

  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 Outcomes (5)

• Quality of Life using DQoL

  Baseline (Day 0) and End of the 3rd Month

• IL-6

  Baseline (Day 0) and End of the 3rd Month

• IL-10

  Baseline (Day 0) and End of the 3rd Month

• D-dimer

  Baseline (Day 0) and End of the 3rd Month

• CRP

  Baseline (Day 0) and End of the 3rd Month

Study Arms (2)

Group 1: Intervention Group

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

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

Group 2: Control Group

PLACEBO COMPARATOR

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

Interventions

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.

Group 1: Intervention Group

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.

Group 2: Control Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

UNIMUS Hospital

Semarang, Central Java, Indonesia

Location

Related Publications (6)

• Li CJ, Xiao Y, Sun YC, He WZ, Liu L, Huang M, He C, Huang M, Chen KX, Hou J, Feng X, Su T, Guo Q, Huang Y, Peng H, Yang M, Liu GH, Luo XH. Senescent immune cells release grancalcin to promote skeletal aging. Cell Metab. 2021 Oct 5;33(10):1957-1973.e6. doi: 10.1016/j.cmet.2021.08.009. Epub 2021 Sep 9.

  PMID: 34614408 BACKGROUND

• Kalluri R, LeBleu VS. The biology, function, and biomedical applications of exosomes. Science. 2020 Feb 7;367(6478):eaau6977. doi: 10.1126/science.aau6977.

  PMID: 32029601 BACKGROUND

• Lai RC, Yeo RW, Lim SK. Mesenchymal stem cell exosomes. Semin Cell Dev Biol. 2015 Apr;40:82-8. doi: 10.1016/j.semcdb.2015.03.001. Epub 2015 Mar 9.

  PMID: 25765629 BACKGROUND

• Raposo G, Stoorvogel W. Extracellular vesicles: exosomes, microvesicles, and friends. J Cell Biol. 2013 Feb 18;200(4):373-83. doi: 10.1083/jcb.201211138.

  PMID: 23420871 BACKGROUND

• American Diabetes Association. Standards of Medical Care in Diabetes-2021 Abridged for Primary Care Providers. Clin Diabetes. 2021 Jan;39(1):14-43. doi: 10.2337/cd21-as01. No abstract available.

  PMID: 33551551 BACKGROUND

• Williams R, Karuranga S, Malanda B, Saeedi P, Basit A, Besancon S, Bommer C, Esteghamati A, Ogurtsova K, Zhang P, Colagiuri S. Global and regional estimates and projections of diabetes-related health expenditure: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2020 Apr;162:108072. doi: 10.1016/j.diabres.2020.108072. Epub 2020 Feb 13.

  PMID: 32061820 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

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

CONTACT

085227700340; dr.yanuardani@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: open-label randomized controlled trial with a pre-and-post-test control group design. The study aims to compare the effectiveness of Mesenchymal Stromal/Stem Cells-Derived Exosomes (MSC-Exos) as an additional therapy for patients with Type 2 Diabetes Mellitus (T2DM). The study will recruit 50 subjects who meet the inclusion and exclusion criteria. These subjects will be randomly assigned to one of two groups Intervention Group: This group will receive standard T2DM therapy along with a combination of exosomes, specifically 1 vial of Exo-HWS and 1 vial of Exo-HUVEC. The exosome therapy will be administered as an intravenous bolus injection monthly, for three months. Control Group: This group will receive standard T2DM therapy plus 1 vial of Exo-HWS. This therapy will also be administered monthly, for three months, via intravenous bolus injection.

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: September 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)