Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis

Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis

The aim of the study is to determine the tolerance of apoptotic autologous cells injection in subjects with active rheumatoid arthritis.

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