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Completed

NCT Number: NCT05207995

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Healthcare institution "Minsk City Clinical Endocrinology Center"

Minsk, 220000, Belarus

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous Tolerogenic Dendritic cells

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

Other

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

Primary outcomes

  1. The glucose concentration in blood

    Time frame: 1 month

    To assess the glucose concentration in blood

  2. The glycated hemoglobin concentration

    Time frame: 1 month

    To assess the β-cell function measured by the glycated hemoglobin in blood

  3. The C-peptide level in blood

    Time frame: 1 month

    To assess the β-cell function measured by the C-peptide level

  4. The glucose concentration in blood

    Time frame: 6 months

    To assess the glucose concentration in blood

  5. The glycated hemoglobin concentration

    Time frame: 6 months

    To assess the β-cell function measured by the glycated hemoglobin in blood

  6. The C-peptide level in blood

    Time frame: 6 months

    To assess the β-cell function measured by the C-peptide level

  7. The glucose concentration in blood

    Time frame: 1 year

    To assess the glucose concentration in blood

  8. The glycated hemoglobin concentration

    Time frame: 1 year

    To assess the β-cell function measured by the glycated hemoglobin in blood

  9. The C-peptide level in blood

    Time frame: 1 year

    To assess the β-cell function measured by the C-peptide level

  10. Autoantigen specific T cell count

    Time frame: 1 month

    To determine the autoantigen specific T cell count using the flow cytometry

  11. Autoantigen specific T cell count

    Time frame: 6 months

    To determine the autoantigen specific T cell count using the flow cytometry

  12. Autoantigen specific T cell count

    Time frame: 1 year

    To determine the autoantigen specific T cell count using the flow cytometry

  13. Adverse effects associated with the therapy

    Time frame: 1 month

    Determination of adverse effects associated with the therapy

  14. Adverse effects associated with the therapy

    Time frame: 1 year

    Determination of adverse effects associated with the therapy

Sponsors and collaborators

Lead sponsor

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

Other Gov

Collaborators

  • Belarusian State Medical University

Registry information

Official study title

A Phase ½ Study to Evaluate the Safety and Feasibility of Autologous Tolerogenic Dendritic Cells in Patients With Type 1 Diabetes Mellitus

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 26, 2022
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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