A Phase ½ Study to Evaluate the Safety and Feasibility of Autologous Tolerogenic Dendritic Cells in Patients With Type 1 Diabetes Mellitus
Overview
- Phase
- Phase 1
- Intervention
- Autologous tolerogenic dendritic cells
- Conditions
- Diabetes Mellitus
- Sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Autoantigen specific T cell count
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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.
Investigators
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
Arms & Interventions
Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells
Group 1: Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells
Intervention: Autologous tolerogenic dendritic cells
Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells
Group 1: Patients with Type 1 Diabetes Mellitus receiving standard treatment and Tolerogenic Dendritic Cells
Intervention: Standard treatment according to the clinical protocols
Patients with Type 1 Diabetes Mellitus receiving standard treatment
Group 2: Patients with Type 1 Diabetes Mellitus receiving standard treatment
Intervention: Standard treatment according to the clinical protocols
Outcomes
Primary Outcomes
Autoantigen specific T cell count
Time Frame: 1 year
To determine the autoantigen specific T cell count using the flow cytometry
Adverse effects associated with the therapy
Time Frame: 1 year
Determination of adverse effects associated with the therapy
The glucose concentration in blood
Time Frame: 1 year
To assess the glucose concentration in blood
The glycated hemoglobin concentration
Time Frame: 1 year
To assess the β-cell function measured by the glycated hemoglobin in blood
The C-peptide level in blood
Time Frame: 1 year
To assess the β-cell function measured by the C-peptide level