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
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 diabetes-mellitus
Started Mar 2022
Typical duration for phase_1 diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2021
CompletedFirst Posted
Study publicly available on registry
January 26, 2022
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 26, 2023
CompletedDecember 2, 2025
December 1, 2025
1.8 years
November 29, 2021
December 1, 2025
Conditions
Outcome Measures
Primary Outcomes (14)
The glucose concentration in blood
To assess the glucose concentration in blood
1 month
The glycated hemoglobin concentration
To assess the β-cell function measured by the glycated hemoglobin in blood
1 month
The C-peptide level in blood
To assess the β-cell function measured by the C-peptide level
1 month
The glucose concentration in blood
To assess the glucose concentration in blood
6 months
The glycated hemoglobin concentration
To assess the β-cell function measured by the glycated hemoglobin in blood
6 months
The C-peptide level in blood
To assess the β-cell function measured by the C-peptide level
6 months
The glucose concentration in blood
To assess the glucose concentration in blood
1 year
The glycated hemoglobin concentration
To assess the β-cell function measured by the glycated hemoglobin in blood
1 year
The C-peptide level in blood
To assess the β-cell function measured by the C-peptide level
1 year
Autoantigen specific T cell count
To determine the autoantigen specific T cell count using the flow cytometry
1 month
Autoantigen specific T cell count
To determine the autoantigen specific T cell count using the flow cytometry
6 months
Autoantigen specific T cell count
To determine the autoantigen specific T cell count using the flow cytometry
1 year
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
1 month
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
1 year
Study Arms (2)
Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells
EXPERIMENTALGroup 1: Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells
Patients with Type 1 Diabetes Mellitus receiving standard treatment
ACTIVE COMPARATORGroup 2: Patients with Type 1 Diabetes Mellitus receiving standard treatment
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Healthcare institution "Minsk City Clinical Endocrinology Center"
Minsk, 220000, Belarus
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2021
First Posted
January 26, 2022
Study Start
March 1, 2022
Primary Completion
December 26, 2023
Study Completion
December 26, 2023
Last Updated
December 2, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share