NCT07144241Not yet recruitingPhase 2
Mesenchymal Stromal/Stem Cells-Derived Exosomes (MSC-Exos) Therapy for Type 2 Diabetes Mellitus Patients
Source: ClinicalTrials.gov · Last updated 27 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 20 Aug 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Universitas Indonesia
- Diseases
- Type 2 diabetes
- NCT number
- NCT07144241
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 1 Sept 2025 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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).
Who the study is looking for
- 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.
Age in the registry: 40 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UNIMUS Hospital Coordinator of this site? Confirm its status | Semarang | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.