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Not yet recruiting NCT07144241

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

Phase II Interventional Type 2 Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS + 1 vial Exo-HUVEC) Therapy, Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS ) Therapy.
Who it may be relevant to
Registry conditions: Type 2 Diabetes Mellitus. Basic parameters: 40 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Fasting Blood Glucose (FBG) [Time frame: Baseline (Day 0) and End of the 3rd Month]
  • 2-Hour Postprandial Glucose [Time frame: Baseline (Day 0) and End of the 3rd Month]
  • HbA1c [Time frame: Baseline (Day 0) and End of the 3rd Month]
  • C-peptide [Time frame: Baseline (Day 0) and End of the 3rd Month]
Secondary outcome measures (5)
  • Quality of Life using DQoL [Time frame: Baseline (Day 0) and End of the 3rd Month]
  • IL-6 [Time frame: Baseline (Day 0) and End of the 3rd Month]
  • IL-10 [Time frame: Baseline (Day 0) and End of the 3rd Month]
  • D-dimer [Time frame: Baseline (Day 0) and End of the 3rd Month]
  • CRP [Time frame: Baseline (Day 0) and End of the 3rd Month]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Indonesia · 1 center
  • UNIMUS Hospital — Semarang

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07144241 · YArdani MSC-Exos T2DM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗