Type 2 Diabetes Mellitus
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALBM-MNC and UC-MSC
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
OTHERControl
Standard medicine
Sponsors
Van Hanh General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Who is diagnosed with Type 2 Diabetes Mellitus according to the ADA 3 years or more * Patients are able to read, write and understand ICF form and agree to participate in the study * Males and females between age 18 and 70 years at the screening. * FBG \> 7 mmol/L * 8% ≤ HbA1C ≤ 11% * Fasting C-peptide \> 0.6 ng/ml * Anti GAD (-) * The patient is treated by two oral diabetes medications but uncontrolled blood glucose (HbA1C ≥ 8%)
Exclusion criteria
* Pregnant women, planning to become pregnant and lactating women during the study period * The patient has a disease or a history of vascular disease; history of abdominal or chest aortic disease; * Patients are diagnosed with heart failure degree IV according to NYHA or kidney failure degree IV according to KDIGO; * Patients with severe malignancy or dysplasia within 5 years prior to the study period or who are suffering from severe malignant or dysplasia * Infection is undergoing antibiotic treatment or antibiotics have just been discontinued within 14 days * Hematologic disease or coagulopathy * There are abnormalities in liver function (AST and/or ALT ≥ 2 times or bilirubin ≥ 2.0 times normal value at the time of screening); * Patients with immunodeficiency diseases such as HIV or hepatitis B and C; * Acute or chronic pancreatitis or a history of acute pancreatitis; * Patients taking immunosuppressive drugs (such as azathioprine, methotrexate) within 6 months before the study time or taking immunosuppressive drugs; * The patient is unable to complete the study; * The patient is participating in another study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The level of C-peptid and HOMA-β | enrollment, 1 month, 3 months and 6 months after transplantation | Assess the changes in C-peptid and HOMA-β level after transplantation |
| The level of HOMA-IR and cytokines TNF-α, IL-1β | enrollment, 1 month, 3 months and 6 months after transplantation | Assess the changes in HOMA-IR and cytokines TNF-α, IL-1β level after transplantation |
| Blood glucose level | enrollment, 1 month, 3 months and 6 months after transplantation | Assess the changes in Blood glucose level after transplantation |
| Hemoglobin A1c (HbA1c) level | enrollment, 1 month, 3 months and 6 months after transplantation | Assess the changes in HbA1C level after transplantation |
| Adverse events | during the course of 6 months | Number of adverse events in both groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin dose and drug dosage | enrollment, 1 month, 3 months and 6 months after transplantation | Assess the changes in Insulin dose and drug dosage after transplantation |
Countries
Vietnam
Contacts
Primary ContactPhuong Thi-Bich Le, MSc-MD
Backup ContactStemCellUnit VanHanh
Outcome results
None listed