Diabetes Mellitus
Conditions
Brief summary
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
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.
Interventions
BIOLOGICALAutologous tolerogenic dendritic cells
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
Sponsors
Belarusian State Medical University
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The glucose concentration in blood | 1 month | To assess the glucose concentration in blood |
| The glycated hemoglobin concentration | 1 month | To assess the β-cell function measured by the glycated hemoglobin in blood |
| The C-peptide level in blood | 1 month | To assess the β-cell function measured by the C-peptide level |
| Autoantigen specific T cell count | 1 month | To determine the autoantigen specific T cell count using the flow cytometry |
| Adverse effects associated with the therapy | 1 month | Determination of adverse effects associated with the therapy |
Countries
Belarus
Outcome results
None listed