drugset / Trial / NCT03337165

Autologous Tolerogenic Dendritic Cells for Treatment of Patients With Rheumatoid Arthritis

NCT03337165

Phase 1 Completed 10 enrolled Russian Academy of Medical Sciences
NaSingle-groupOpen-labelTreatment

Summary

Tolerogenic dendritic cell (tDC)-based clinical trials for the treatment of autoimmune diseases are now a reality. Clinical trials are currently exploring the effectiveness of tDC to treat of type 1 diabetes mellitus, rheumatoid arthritis, multiple sclerosis and Crohn's disease. The general objective of this study is to evaluate the safety and tolerability of a single intra-articular injection (into the knee joint) of autologous monocyte-derived dendritic cells generated in the presence of interferon-alpha (IFN-α)/granulocyte-macrophage colony-stimulating factor (GM-CSF) and tolerized with Dexamethasone in rheumatoid arthritis (RA) patients.

Timeline

Start
2016-12
Primary completion
2019-05
Completion
2019-08

Drugs

EvaluationDrugModalityDoseRoute
Subject tolerogenic dendritic cells Cell therapy 1e+06 cells Other
Subject tolerogenic dendritic cells Cell therapy 3e+06 cells Other
Subject tolerogenic dendritic cells Cell therapy 5e+06 cells Other
Subject tolerogenic dendritic cells Cell therapy 8e+06 cells Other
Subject tolerogenic dendritic cells Cell therapy 1e+07 cells Other

Indications