Status:
COMPLETED
The Treatment of Patients With Type 1 Diabetes Mellitus With Autologous Tolerogenic Dendritic Cells
Lead Sponsor:
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborating Sponsors:
Belarusian State Medical University
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
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 ste...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 26 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05207995
Start Date
March 1 2022
End Date
December 26 2023
Last Update
December 2 2025
Active Locations (1)
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1
Healthcare institution "Minsk City Clinical Endocrinology Center"
Minsk, Belarus, 220000