A Phase 1/2 interventional study of Autologous tolerogenic dendritic cells and Standard treatment according to the clinical protocols in Diabetes Mellitus, sponsored by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus. Completed at 1 site in Belarus. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus · Phase 1/2, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 32 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus is the lead sponsor of 24 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group 1: Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells
Biological: Autologous tolerogenic dendritic cells · Other: Standard treatment according to the clinical protocols
Group 2: Patients with Type 1 Diabetes Mellitus receiving standard treatment
Other: Standard treatment according to the clinical protocols
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
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus