Status:
COMPLETED
Autologous Tolerogenic Dendritic Cells for Treatment of Patients With Rheumatoid Arthritis
Lead Sponsor:
Russian Academy of Medical Sciences
Conditions:
Musculoskeletal Diseases
Joint Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 d...
Detailed Description
A phase I dose-escalating clinical trial will be conducted to determine the safety and tolerability of a single intra-articular injection (into the knee joint) of autologous tolerogenic dendritic cell...
Eligibility Criteria
Inclusion
- Age 18 to 75 Years
- Patients with moderate to severe active RA (DAS28 \>=3.2)
- At least 6 month's disease duration
- Synovitis of large joints (knee, elbow)
- Morning stiffness in the target joint ≥ 30 minutes
- Stable dose of disease-modifying anti-rheumatic drugs (DMARD) for ≥16 weeks
- Patients must be able to tolerate all study procedures
- Patients must be willing to voluntarily give written Informed Consent to participate in the study before any procedures are performed
- Patients must be willing to be available for all baseline, treatment and follow-up examinations required by protocol
Exclusion
- Injection of target joint with glucocorticoids within 6 weeks of baseline
- Known hypersensitivity to gentamicin or local anaesthetics
- Dementia, psychiatric disorders
- Renal dysfunctions
- Hemodynamic or respiratory instability
- HIV or uncontrolled bacterial, fungal, or viral infections
- Pregnancy
- Malignancy
- Participation in other clinical trials
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03337165
Start Date
December 1 2016
End Date
August 1 2019
Last Update
September 13 2019
Active Locations (1)
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1
Institute of Fundamental and Clinical Immunology
Novosibirsk, Russia, 630099