The Treatment of Patients With Type 1 Diabetes Mellitus With Autologous Tolerogenic Dendritic Cells

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase ½ Study to Evaluate the Safety and Feasibility of Autologous Tolerogenic Dendritic Cells in Patients With Type 1 Diabetes Mellitus

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Biological: Autologous tolerogenic dendritic cells
* Other: Standard treatment according to the clinical protocols


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Type 1 Diabetes Mellitus The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation Written informed consent Exclusion Criteria: The presence of any malignant tumor within the last 5 years Acute or chronic diseases in the stage of decompensation Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis Patients who are pregnant, breastfeeding, or fertile patients who are not using adequate contraceptive methods Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol Patients are unable or unwilling to give written informed consent and / or follow research procedures Any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells<br>Group 1: Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells | Biological: Autologous tolerogenic dendritic cells<br>* Autologous tolerogenic dendritic cells treated with Vitamin-D3, co-cultivated with mesenchymal stem cell and primed peptides (MSC-tolDC) injected subcutaneous.<br>Other: Standard treatment according to the clinical protocols<br>* Standard treatment of type 1 diabetes mellitus according to the clinical protocols<br>|
| Active Comparator: Patients with Type 1 Diabetes Mellitus receiving standard treatment<br>Group 2: Patients with Type 1 Diabetes Mellitus receiving standard treatment | Other: Standard treatment according to the clinical protocols<br>* Standard treatment of type 1 diabetes mellitus according to the clinical protocols<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 |