The Treatment of Patients With Type 1 Diabetes Mellitus With Autologous Tolerogenic Dendritic Cells
NCT ID: NCT05207995
Last Updated: 2025-12-02
Study Results
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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COMPLETED
PHASE1/PHASE2
32 participants
INTERVENTIONAL
2022-03-01
2023-12-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
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
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.
Standard treatment according to the clinical protocols
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
Standard treatment according to the clinical protocols
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.
Standard treatment according to the clinical protocols
Standard treatment of type 1 diabetes mellitus according to the clinical protocols
Eligibility Criteria
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Inclusion Criteria
* The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
* Written informed consent
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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Belarusian State Medical University
OTHER
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
OTHER_GOV
Responsible Party
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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
Countries
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Other Identifiers
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IBCE_DM
Identifier Type: -
Identifier Source: org_study_id
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