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
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
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-
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Minsk, Belarus, 220000
- Healthcare institution "Minsk City Clinical Endocrinology Center"
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-
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
|
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
|
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Active Comparator: Patients with Type 1 Diabetes Mellitus receiving standard treatment
Group 2: Patients with Type 1 Diabetes Mellitus receiving standard treatment
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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
|
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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.
Collaborators
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
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