Status:
UNKNOWN
BM-MNC and UCMSC for Type 2 Diabetes Mellitus Patients
Lead Sponsor:
Indonesia University
Collaborating Sponsors:
Dr Cipto Mangunkusumo General Hospital
Conditions:
T2D
Eligibility:
All Genders
30-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The aim of this preliminary study is to evaluate the safety and efficacy of bone-marrow mononuclear cells (BM-MNCs) and umbilical-cord tissue-derived mesenchymal stem cells (UC-MSCs) administration in...
Detailed Description
Type 2 diabetes (T2D) patients had peripheral insulin resistance accompanied by progressive pancreatic beta cell degeneration and dysfunction due to glucotoxicity and lipotoxicity. Several studies hav...
Eligibility Criteria
Inclusion
- Type 2 diabetes patients on insulin therapy with or without oral hypoglycemic agents, with total daily dose of insulin \>= 0,5 unit/kg body weight
- Stable HbA1C in the last six months (HbA1c \<= 8.5%)
Exclusion
- Type 1 diabetes mellitus
- eGFR \< 45 mL/min/m2 (for BM-MNC)
- Liver disease (moderate- severe)
- Active infection
- Contrast hypersensitivity (for BM-MNC)
- History of Malignancy
- Acute coronary syndrome in last three months
- Coronary arterial diseases with significant stenosis and has not carried out revascularization
- Pregnancy (for women subjects)
Key Trial Info
Start Date :
March 14 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04501341
Start Date
March 14 2016
End Date
December 1 2021
Last Update
August 6 2020
Active Locations (1)
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1
Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, DKI Jakarta, Indonesia, 10430