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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Autologous tolerogenic dendritic cells treated with Vitamin-D3, co-cultivated with mesenchymal stem cell and primed peptides (MSC-tolDC) injected subcutaneous.
Standard treatment of type 1 diabetes mellitus according to the clinical protocols
Healthcare institution "Minsk City Clinical Endocrinology Center"
Minsk, Belarus
The glucose concentration in blood
To assess the glucose concentration in blood
Time frame: 1 month
The glycated hemoglobin concentration
To assess the β-cell function measured by the glycated hemoglobin in blood
Time frame: 1 month
The C-peptide level in blood
To assess the β-cell function measured by the C-peptide level
Time frame: 1 month
The glucose concentration in blood
To assess the glucose concentration in blood
Time frame: 6 months
The glycated hemoglobin concentration
To assess the β-cell function measured by the glycated hemoglobin in blood
Time frame: 6 months
The C-peptide level in blood
To assess the β-cell function measured by the C-peptide level
Time frame: 6 months
The glucose concentration in blood
To assess the glucose concentration in blood
Time frame: 1 year
The glycated hemoglobin concentration
To assess the β-cell function measured by the glycated hemoglobin in blood
Time frame: 1 year
The C-peptide level in blood
To assess the β-cell function measured by the C-peptide level
Time frame: 1 year
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Autoantigen specific T cell count
To determine the autoantigen specific T cell count using the flow cytometry
Time frame: 1 month
Autoantigen specific T cell count
To determine the autoantigen specific T cell count using the flow cytometry
Time frame: 6 months
Autoantigen specific T cell count
To determine the autoantigen specific T cell count using the flow cytometry
Time frame: 1 year
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
Time frame: 1 month
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
Time frame: 1 year