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

NCT ID: NCT05207995

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-12-26

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Autologous tolerogenic dendritic cells

Intervention Type BIOLOGICAL

Autologous tolerogenic dendritic cells treated with Vitamin-D3, co-cultivated with mesenchymal stem cell and primed peptides (MSC-tolDC) injected subcutaneous.

Standard treatment according to the clinical protocols

Intervention Type OTHER

Standard treatment of type 1 diabetes mellitus according to the clinical protocols

Patients with Type 1 Diabetes Mellitus receiving standard treatment

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

Group Type ACTIVE_COMPARATOR

Standard treatment according to the clinical protocols

Intervention Type OTHER

Standard treatment of type 1 diabetes mellitus according to the clinical protocols

Interventions

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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.

Intervention Type BIOLOGICAL

Standard treatment according to the clinical protocols

Standard treatment of type 1 diabetes mellitus according to the clinical protocols

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Belarusian State Medical University

OTHER

Sponsor Role collaborator

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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[email protected] Antonevich, Dr

Role: STUDY_DIRECTOR

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

Tatiana Mokhort, Prof

Role: STUDY_DIRECTOR

Belarusian State Medical University

Andrei Y Hancharou, Dr.

Role: STUDY_DIRECTOR

The Institute for Biophysics and Cell Engineering of the NAS of Belarus

Yana S Minich

Role: PRINCIPAL_INVESTIGATOR

The Institute for Biophysics and Cell Engineering of the NAS of Belarus

Locations

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Healthcare institution "Minsk City Clinical Endocrinology Center"

Minsk, , Belarus

Site Status

Countries

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Belarus

Other Identifiers

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IBCE_DM

Identifier Type: -

Identifier Source: org_study_id

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