Status:
NOT_YET_RECRUITING
Mesenchymal Stromal/Stem Cells-Derived Exosomes (MSC-Exos) Therapy for Type 2 Diabetes Mellitus Patients
Lead Sponsor:
Indonesia University
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
40-65 years
Phase:
PHASE2
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 th...
Eligibility Criteria
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 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).
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07144241
Start Date
September 1 2025
End Date
July 1 2026
Last Update
August 27 2025
Active Locations (1)
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1
UNIMUS Hospital
Semarang, Central Java, Indonesia