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

December 1, 2025 updated by: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus, 220000
        • Healthcare institution "Minsk City Clinical Endocrinology Center"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional 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
Group 1: Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells
Biological: Autologous tolerogenic dendritic cells
Autologous tolerogenic dendritic cells treated with Vitamin-D3, co-cultivated with mesenchymal stem cell and primed peptides (MSC-tolDC) injected subcutaneous.
Other: Standard treatment according to the clinical protocols
Standard treatment of type 1 diabetes mellitus according to the clinical protocols
Active Comparator: Patients with Type 1 Diabetes Mellitus receiving standard treatment
Group 2: Patients with Type 1 Diabetes Mellitus receiving standard treatment
Other: Standard treatment according to the clinical protocols
Standard treatment of type 1 diabetes mellitus according to the clinical protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects associated with the therapy
Time Frame: 1 month
Determination of adverse effects associated with the therapy
1 month
Adverse effects associated with the therapy
Time Frame: 1 year
Determination of adverse effects associated with the therapy
1 year
The glucose concentration in blood
Time Frame: 1 month
To assess the glucose concentration in blood
1 month
The glycated hemoglobin concentration
Time Frame: 1 month
To assess the β-cell function measured by the glycated hemoglobin in blood
1 month
The C-peptide level in blood
Time Frame: 1 month
To assess the β-cell function measured by the C-peptide level
1 month
The glucose concentration in blood
Time Frame: 6 months
To assess the glucose concentration in blood
6 months
The glycated hemoglobin concentration
Time Frame: 6 months
To assess the β-cell function measured by the glycated hemoglobin in blood
6 months
The C-peptide level in blood
Time Frame: 6 months
To assess the β-cell function measured by the C-peptide level
6 months
The glucose concentration in blood
Time Frame: 1 year
To assess the glucose concentration in blood
1 year
The glycated hemoglobin concentration
Time Frame: 1 year
To assess the β-cell function measured by the glycated hemoglobin in blood
1 year
The C-peptide level in blood
Time Frame: 1 year
To assess the β-cell function measured by the C-peptide level
1 year
Autoantigen specific T cell count
Time Frame: 1 month
To determine the autoantigen specific T cell count using the flow cytometry
1 month
Autoantigen specific T cell count
Time Frame: 6 months
To determine the autoantigen specific T cell count using the flow cytometry
6 months
Autoantigen specific T cell count
Time Frame: 1 year
To determine the autoantigen specific T cell count using the flow cytometry
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Belarusian State Medical University

Investigators

  • Study Director: antonevich.n@gmail.com Antonevich, Dr, the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
  • Study Director: Tatiana Mokhort, Prof, Belarusian State Medical University
  • Study Director: Andrei Y Hancharou, Dr., The Institute for Biophysics and Cell Engineering of the NAS of Belarus
  • Principal Investigator: Yana S Minich, The Institute for Biophysics and Cell Engineering of the NAS of Belarus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

December 26, 2023

Study Completion (Actual)

December 26, 2023

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

January 12, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBCE_DM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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