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Autologous Tolerogenic Dendritic Cells for Treatment of Patients With Rheumatoid Arthritis

NCT03337165 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-09-13

No results posted yet for this study

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.

Conditions

  • Musculoskeletal Diseases
  • Joint Disease
  • Arthritis
  • Arthritis, Rheumatoid
  • Rheumatic Diseases
  • Connective Tissue Diseases
  • Autoimmune Diseases
  • Immune System Diseases

Interventions

BIOLOGICAL

tolerogenic dendritic cells

dose-escalation

Sponsors & Collaborators

  • Russian Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Elena R Chernykh, MD, PhD · Institute of Fundamental and Clinical Immunology

  • Alexander A Ostanin, MD, PhD · Institute of Fundamental and Clinical Immunology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2019-05-31
Completion
2019-08-31

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03337165 on ClinicalTrials.gov