search
Back to results

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

Primary Purpose

Diabetes Mellitus

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Autologous tolerogenic dendritic cells
Standard treatment according to the clinical protocols
Sponsored by
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells

    Patients with Type 1 Diabetes Mellitus receiving standard treatment

    Arm Description

    Group 1: Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells

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

    Outcomes

    Primary Outcome Measures

    The glucose concentration in blood
    To assess the glucose concentration in blood
    The glycated hemoglobin concentration
    To assess the β-cell function measured by the glycated hemoglobin in blood
    The C-peptide level in blood
    To assess the β-cell function measured by the C-peptide level
    The glucose concentration in blood
    To assess the glucose concentration in blood
    The glycated hemoglobin concentration
    To assess the β-cell function measured by the glycated hemoglobin in blood
    The C-peptide level in blood
    To assess the β-cell function measured by the C-peptide level
    The glucose concentration in blood
    To assess the glucose concentration in blood
    The glycated hemoglobin concentration
    To assess the β-cell function measured by the glycated hemoglobin in blood
    The C-peptide level in blood
    To assess the β-cell function measured by the C-peptide level
    Autoantigen specific T cell count
    To determine the autoantigen specific T cell count using the flow cytometry
    Autoantigen specific T cell count
    To determine the autoantigen specific T cell count using the flow cytometry
    Autoantigen specific T cell count
    To determine the autoantigen specific T cell count using the flow cytometry
    Adverse effects associated with the therapy
    Determination of adverse effects associated with the therapy
    Adverse effects associated with the therapy
    Determination of adverse effects associated with the therapy

    Secondary Outcome Measures

    Full Information

    First Posted
    November 29, 2021
    Last Updated
    January 12, 2022
    Sponsor
    Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
    Collaborators
    Belarusian State Medical University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05207995
    Brief Title
    The Treatment of Patients With Type 1 Diabetes Mellitus With Autologous Tolerogenic Dendritic Cells
    Official Title
    A Phase ½ Study to Evaluate the Safety and Feasibility of Autologous Tolerogenic Dendritic Cells in Patients With Type 1 Diabetes Mellitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
    Collaborators
    Belarusian State Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells
    Arm Type
    Experimental
    Arm Description
    Group 1: Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells
    Arm Title
    Patients with Type 1 Diabetes Mellitus receiving standard treatment
    Arm Type
    Active Comparator
    Arm Description
    Group 2: Patients with Type 1 Diabetes Mellitus receiving standard treatment
    Intervention Type
    Biological
    Intervention Name(s)
    Autologous tolerogenic dendritic cells
    Intervention Description
    Autologous tolerogenic dendritic cells treated with Vitamin-D3, co-cultivated with mesenchymal stem cell and primed peptides (MSC-tolDC) injected subcutaneous.
    Intervention Type
    Other
    Intervention Name(s)
    Standard treatment according to the clinical protocols
    Intervention Description
    Standard treatment of type 1 diabetes mellitus according to the clinical protocols
    Primary Outcome Measure Information:
    Title
    The glucose concentration in blood
    Description
    To assess the glucose concentration in blood
    Time Frame
    1 month
    Title
    The glycated hemoglobin concentration
    Description
    To assess the β-cell function measured by the glycated hemoglobin in blood
    Time Frame
    1 month
    Title
    The C-peptide level in blood
    Description
    To assess the β-cell function measured by the C-peptide level
    Time Frame
    1 month
    Title
    The glucose concentration in blood
    Description
    To assess the glucose concentration in blood
    Time Frame
    6 months
    Title
    The glycated hemoglobin concentration
    Description
    To assess the β-cell function measured by the glycated hemoglobin in blood
    Time Frame
    6 months
    Title
    The C-peptide level in blood
    Description
    To assess the β-cell function measured by the C-peptide level
    Time Frame
    6 months
    Title
    The glucose concentration in blood
    Description
    To assess the glucose concentration in blood
    Time Frame
    1 year
    Title
    The glycated hemoglobin concentration
    Description
    To assess the β-cell function measured by the glycated hemoglobin in blood
    Time Frame
    1 year
    Title
    The C-peptide level in blood
    Description
    To assess the β-cell function measured by the C-peptide level
    Time Frame
    1 year
    Title
    Autoantigen specific T cell count
    Description
    To determine the autoantigen specific T cell count using the flow cytometry
    Time Frame
    1 month
    Title
    Autoantigen specific T cell count
    Description
    To determine the autoantigen specific T cell count using the flow cytometry
    Time Frame
    6 months
    Title
    Autoantigen specific T cell count
    Description
    To determine the autoantigen specific T cell count using the flow cytometry
    Time Frame
    1 year
    Title
    Adverse effects associated with the therapy
    Description
    Determination of adverse effects associated with the therapy
    Time Frame
    1 month
    Title
    Adverse effects associated with the therapy
    Description
    Determination of adverse effects associated with the therapy
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Natalia Antonevich, Dr
    Phone
    +375173691763
    Email
    antonevich.n@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andrei Hancharou, Dr
    Phone
    +375296248972
    Email
    hancharou@ibp.org.by
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    antonevich.n@gmail.com Antonevich, Dr
    Organizational Affiliation
    the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Tatiana Mokhort, Prof
    Organizational Affiliation
    Belarusian State Medical University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs