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The purpose of this study is to evaluate the feasibility, efficacy and safety of transplantation therapy using bone marrow mononuclear cells and umbilical cord mesenchymal stem cells for patients with type 1 diabetes mellitus
To evaluate the feasibility, safety and efficacy of transplantation using autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells in patients with type 1 diabetes mellitus.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells | Biological | First Transplantation: after finishing all required examines according to protocol on Day 0, ABM-MNCs + UCMSCs are transplanted through pancreas artery percutaneously; Second Transplantation: after finishing all required examines on Day 7±1, BM-MNCs UCMSCs are transplanted intravenously; Third Transplantation: after finishing all required examines on Day 14±2, BM-MNCs + UCMSCs are transplanted intravenously. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of reducing exogenous insulin requirement; Hemoglobin A1c; Fast blood glucose (FBG) and postmeal blood glucose (PBG); C-peptide levels. | Rate of reducing exogenous insulin requirement compared with baseline. Hemoglobin A1c. Fast blood glucose (FBG) and postmeal blood glucose (PBG). C-peptide levels. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Serious adverse event frequency and severity | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shi X Y, M.D. | Armed Police General Hospital, P. R. China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Armed Police General Hospital, P. R. China | Beijing | 100085 | China |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |