Clinical trial NCT05207995: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Diabetes Mellitus
Lead sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Sponsor class: OTHER_GOV
Collaborators: name: Belarusian State Medical University
First posted: 2022-01-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The glucose concentration in blood
timeFrame: 1 month
measure: The glycated hemoglobin concentration
timeFrame: 1 month
measure: The C-peptide level in blood
timeFrame: 1 month
measure: The glucose concentration in blood
timeFrame: 6 months
measure: The glycated hemoglobin concentration
timeFrame: 6 months
measure: The C-peptide level in blood
timeFrame: 6 months
measure: The glucose concentration in blood
timeFrame: 1 year
measure: The glycated hemoglobin concentration
timeFrame: 1 year
measure: The C-peptide level in blood
timeFrame: 1 year
measure: Autoantigen specific T cell count
timeFrame: 1 month
measure: Autoantigen specific T cell count
timeFrame: 6 months
measure: Autoantigen specific T cell count
timeFrame: 1 year
measure: Adverse effects associated with the therapy
timeFrame: 1 month
measure: Adverse effects associated with the therapy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
name: antonevich.n@gmail.com Antonevich, Dr
role: STUDY_DIRECTOR
affiliation: Belarusian State Medical University
name: Tatiana Mokhort, Prof
role: STUDY_DIRECTOR
References: