Tests stem cell-derived exosome therapy added to care for type 2 diabetes
Tests exosomes from stem cells added to usual care in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: Mesenchymal Stromal/Stem Cells-Derived Exosomes (MSC-Exos) Therapy for Type 2 Diabetes Mellitus Patients
Key facts
- Where
- Semarang, IndonesiaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 65 years old?
Source: NCT07144241, who can take part
Where in Indonesia
- UNIMUS HospitalSemarang, IndonesiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitas Indonesia
- Trial code
- NCT07144241
- Record updated
- 27 August 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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 severe comorbidities that could affect the immune response, such as autoimmune diseases, malignancies, and severe infections; Patients with a history of severe allergies to components of the exosome therapy; Patients with CKD (Chronic Kidney Disease) on HD (Hemodialysis).