Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis
Phase 1
Not yet recruiting
- Conditions
- Arthritis, Rheumatoid
- Interventions
- Biological: Autologous apoptotic cells injection
- Registration Number
- NCT02903212
- Lead Sponsor
- Centre Hospitalier Universitaire de Besancon
- Brief Summary
The aim of the study is to determine the tolerance of apoptotic autologous cells injection in subjects with active rheumatoid arthritis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
- Patients with a diagnosis of Rheumatoid arthritis
- Therapy failure with at least one biological agent from anti-TNF-alpha (etanercept, infliximab, adalimumab, certolizumab and golimumab; 3 months at optimal dose), anti-IL6 (tocilizumab; 3 months); T-cell costimulatory pathway inhibitor (abatacept; 3 months); anti-CD20 (rituximab; 6 months at optimal dose); Anti IL-1 (anakinra; 3 months)
- Disease Activity Score (DAS) DAS28 ≥ 3.2
- Subject has provided written informed consent
Exclusion Criteria
- Pregnant or lactating women
- Inflammatory arthritis other than rheumatoid arthritis
- History of invasive cancer
- Immunodeficiency (HIV infection, Immunosuppressive therapy)
- Active bacterial or viral infections, in particular HCV or HBV.
- Surgery not older than 4 weeks.
- Unstable comorbidities: uncontrolled diabetes, heart disease, advanced renal or hepatic impairment.
- Contraindication to an apheresis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rheumatoid arthritis Autologous apoptotic cells injection Patients with rheumatoid arthritis. An injection of autologous apoptotic cells is performed on the D0.
- Primary Outcome Measures
Name Time Method Tolerance of apoptotic cells injection 12 weeks Side effects are taken into account to assess tolerance.
- Secondary Outcome Measures
Name Time Method