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

A Phase ½ Study to Evaluate the Safety and Feasibility of Autologous 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 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.

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