NCT05207995

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

A Phase ½ Study to Evaluate the Safety and Feasibility of Autologous Tolerogenic Dendritic Cells in Patients With Type 1 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-12-26
• Completion: 2023-12-26
• First posted: 2022-01-26
• Last updated: 2025-12-02

Locations

1 site across 1 country: Belarus