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| Name | Class |
|---|---|
| Belarusian State Medical University | OTHER |
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The purpose of this study is to determine the safety and tolerability of the administration of tolerogenic dendritic cells in patients with type 1 diabetes mellitus.
The purpose of this study is to determine the safety and tolerability of the administration of autologous monocyte-derived dendritic cells tolerised with Vitamin-D3, co-cultivated with mesenchymal stem cell and primed peptides in patients with type 1 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells | Experimental | Group 1: Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells |
|
| Patients with Type 1 Diabetes Mellitus receiving standard treatment | Active Comparator | Group 2: Patients with Type 1 Diabetes Mellitus receiving standard treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous tolerogenic dendritic cells | Biological | Autologous tolerogenic dendritic cells treated with Vitamin-D3, co-cultivated with mesenchymal stem cell and primed peptides (MSC-tolDC) injected subcutaneous. |
| Measure | Description | Time Frame |
|---|---|---|
| The glucose concentration in blood | To assess the glucose concentration in blood | 1 month |
| The glycated hemoglobin concentration | To assess the β-cell function measured by the glycated hemoglobin in blood | 1 month |
| The C-peptide level in blood | To assess the β-cell function measured by the C-peptide level | 1 month |
| The glucose concentration in blood | To assess the glucose concentration in blood | 6 months |
| The glycated hemoglobin concentration | To assess the β-cell function measured by the glycated hemoglobin in blood | 6 months |
| The C-peptide level in blood | To assess the β-cell function measured by the C-peptide level | 6 months |
| The glucose concentration in blood | To assess the glucose concentration in blood | 1 year |
| The glycated hemoglobin concentration | To assess the β-cell function measured by the glycated hemoglobin in blood | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| antonevich.n@gmail.com Antonevich, Dr | the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus | Study Director |
| Tatiana Mokhort, Prof | Belarusian State Medical University | Study Director |
| Andrei Y Hancharou, Dr. | The Institute for Biophysics and Cell Engineering of the NAS of Belarus | Study Director |
| Yana S Minich | The Institute for Biophysics and Cell Engineering of the NAS of Belarus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healthcare institution "Minsk City Clinical Endocrinology Center" | Minsk | 220000 | Belarus |
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| Standard treatment according to the clinical protocols | Other | Standard treatment of type 1 diabetes mellitus according to the clinical protocols |
|
| The C-peptide level in blood | To assess the β-cell function measured by the C-peptide level | 1 year |
| Autoantigen specific T cell count | To determine the autoantigen specific T cell count using the flow cytometry | 1 month |
| Autoantigen specific T cell count | To determine the autoantigen specific T cell count using the flow cytometry | 6 months |
| Autoantigen specific T cell count | To determine the autoantigen specific T cell count using the flow cytometry | 1 year |
| Adverse effects associated with the therapy | Determination of adverse effects associated with the therapy | 1 month |
| Adverse effects associated with the therapy | Determination of adverse effects associated with the therapy | 1 year |
| ID | Term |
|---|---|
| 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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