Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis (APO-RA)

Centre Hospitalier Universitaire de Besancon

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Arthritis, Rheumatoid

Treatments: Biological: Autologous apoptotic cells injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02903212

P/2013/196

Details and patient eligibility

About

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

Enrollment: 22 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Rheumatoid arthritis

Experimental group

Description:

Patients with rheumatoid arthritis. An injection of autologous apoptotic cells is performed on the D0.

Treatment:

Biological: Autologous apoptotic cells injection