The purpose of this study is to evaluate the preliminary safety and efficacy of autologous bone marrow mononuclear cells (BM-MNCs) and allogeneic umbilical cord tissue-derived mesenchymal stem cells (UC-MSCs) infusion in type 2 Diabetes Mellitus patients.
Mononuclear cells are collected from autologous bone marrow and allogeneic mesenchymal stem cells are isolated and cultured from umbilical cord tissues. 30 patients with Type 2 Diabetes Mellitus will be enrolled and received mononuclear cell and mesenchymal stem cell by intravenous infusion and followed up for 6 months. The other 30 patients with Type 2 Diabetes Mellitus will be enrolled and treated by standard medicines, which would be used as the control group. Safety is to assess the occurrence of adverse events (AEs) during either stem cells infusion or by physician assessments. The primary endpoint is to assess the improvement of patient's C-peptid and HOMA-β, HOMA-IR, cytokines TNF-α, IL-1β, Blood glucose level, Hemoglobin A1c (HbA1c) level.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Autologous bone marrow mononuclear cells (BM-MNCs) and allogeneic umbilical cord tissue-derived mesenchymal stem cells (UC-MSCs) under sterile conditions to treat this disease. UC-MSC: 1-2 x 10\^6 cells/kg
Standard medicine
Van Hanh General Hospital
Ho Chi Minh City, Ho Chi Minh, Vietnam
RECRUITINGThe level of C-peptid and HOMA-β
Assess the changes in C-peptid and HOMA-β level after transplantation
Time frame: enrollment, 1 month, 3 months and 6 months after transplantation
The level of HOMA-IR and cytokines TNF-α, IL-1β
Assess the changes in HOMA-IR and cytokines TNF-α, IL-1β level after transplantation
Time frame: enrollment, 1 month, 3 months and 6 months after transplantation
Blood glucose level
Assess the changes in Blood glucose level after transplantation
Time frame: enrollment, 1 month, 3 months and 6 months after transplantation
Hemoglobin A1c (HbA1c) level
Assess the changes in HbA1C level after transplantation
Time frame: enrollment, 1 month, 3 months and 6 months after transplantation
Adverse events
Number of adverse events in both groups
Time frame: during the course of 6 months
Insulin dose and drug dosage
Assess the changes in Insulin dose and drug dosage after transplantation
Time frame: enrollment, 1 month, 3 months and 6 months after transplantation
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