Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BM-MNC and UC-MSC | Experimental | 30 patients with Type 2 Diabetes Mellitus will be enrolled and received mononuclear cells and mesenchymal stem cells by intravenous infusion. |
|
| Stand medicines | Other | 30 patients with Type 2 Diabetes Mellitus will be enrolled and treated by standard medicines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BM-MNC and UC-MSC | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The level of C-peptid and HOMA-β | Assess the changes in C-peptid and HOMA-β level after transplantation | 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 | enrollment, 1 month, 3 months and 6 months after transplantation |
| Blood glucose level | Assess the changes in Blood glucose level after transplantation | enrollment, 1 month, 3 months and 6 months after transplantation |
| Hemoglobin A1c (HbA1c) level | Assess the changes in HbA1C level after transplantation | enrollment, 1 month, 3 months and 6 months after transplantation |
| Adverse events | Number of adverse events in both groups | during the course of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin dose and drug dosage | Assess the changes in Insulin dose and drug dosage after transplantation | enrollment, 1 month, 3 months and 6 months after transplantation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Phuong Thi-Bich Le, MSc-MD | Contact | 902742732 | +84 | drbphuong@gmail.com |
| StemCellUnit VanHanh | Contact | tebaogocvanhanh@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Phuong Thi-Bich Le, MSc-MD | Stem Cell Unit, Van Hanh General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Van Hanh General Hospital | Recruiting | Ho Chi Minh City | Ho Chi Minh | 700000 | Vietnam |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control | Other | Standard medicine |
|
| D004700 | Endocrine System Diseases |