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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05207995
Other study ID # IBCE_DM
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 1, 2022
Est. completion date December 31, 2023

Study information

Verified date January 2022
Source Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Contact Natalia Antonevich, Dr
Phone +375173691763
Email antonevich.n@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
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.
Other:
Standard treatment according to the clinical protocols
Standard treatment of type 1 diabetes mellitus according to the clinical protocols

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus Belarusian State Medical University

Outcome

Type Measure Description Time frame Safety issue
Primary The glucose concentration in blood To assess the glucose concentration in blood 1 month
Primary The glycated hemoglobin concentration To assess the ß-cell function measured by the glycated hemoglobin in blood 1 month
Primary The C-peptide level in blood To assess the ß-cell function measured by the C-peptide level 1 month
Primary The glucose concentration in blood To assess the glucose concentration in blood 6 months
Primary The glycated hemoglobin concentration To assess the ß-cell function measured by the glycated hemoglobin in blood 6 months
Primary The C-peptide level in blood To assess the ß-cell function measured by the C-peptide level 6 months
Primary The glucose concentration in blood To assess the glucose concentration in blood 1 year
Primary The glycated hemoglobin concentration To assess the ß-cell function measured by the glycated hemoglobin in blood 1 year
Primary The C-peptide level in blood To assess the ß-cell function measured by the C-peptide level 1 year
Primary Autoantigen specific T cell count To determine the autoantigen specific T cell count using the flow cytometry 1 month
Primary Autoantigen specific T cell count To determine the autoantigen specific T cell count using the flow cytometry 6 months
Primary Autoantigen specific T cell count To determine the autoantigen specific T cell count using the flow cytometry 1 year
Primary Adverse effects associated with the therapy Determination of adverse effects associated with the therapy 1 month
Primary Adverse effects associated with the therapy Determination of adverse effects associated with the therapy 1 year
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