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

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Status and phase: Completed; Phase 2; Phase 1

Conditions: Diabetes Mellitus

Treatments: Other: Standard treatment according to the clinical protocols; Biological: Autologous tolerogenic dendritic cells

Study type: Interventional

Funder types: Other

Identifiers

NCT05207995

IBCE_DM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells

Experimental group

Description:

Group 1: Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells

Treatment:

Biological: Autologous tolerogenic dendritic cells

Other: Standard treatment according to the clinical protocols

Patients with Type 1 Diabetes Mellitus receiving standard treatment

Active Comparator group

Description:

Group 2: Patients with Type 1 Diabetes Mellitus receiving standard treatment

Treatment:

Other: Standard treatment according to the clinical protocols