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

Phase 1

• Conditions: Diabetes Mellitus
• Interventions: Biological: Autologous tolerogenic dendritic cells; Other: Standard treatment according to the clinical protocols

• Registration Number: NCT05207995
• Lead Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

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.

Study Timeline

• Study First Submitted: 2021-11-29
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-12
• Last Update Submitted: 2022-01-12
• Study First Posted: 2022-01-26
• Last Update Posted: 2022-01-26
• Study Start: 2022-03-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells	Standard treatment according to the clinical protocols	Group 1: Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells
Patients with Type 1 Diabetes Mellitus receiving standard treatment	Standard treatment according to the clinical protocols	Group 2: Patients with Type 1 Diabetes Mellitus receiving standard treatment
Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells	Autologous tolerogenic dendritic cells	Group 1: Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells

Primary Outcome Measures

Name	Time	Method
Autoantigen specific T cell count	1 year	To determine the autoantigen specific T cell count using the flow cytometry
Adverse effects associated with the therapy	1 year	Determination of adverse effects associated with the therapy
The glucose concentration in blood	1 year	To assess the glucose concentration in blood
The glycated hemoglobin concentration	1 year	To assess the β-cell function measured by the glycated hemoglobin in blood
The C-peptide level in blood	1 year	To assess the β-cell function measured by the C-peptide level