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

Phase 1

Not yet recruiting

• Conditions: Arthritis, Rheumatoid

• 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

Study Timeline

• Study First Submitted: 2016-09-01
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-16
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-06
• Study Start: 2023-03
• Primary Completion: 2024-06
• Study Completion: 2024-12

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

Primary Outcome Measures

Name	Time	Method
Tolerance of apoptotic cells injection	12 weeks	Side effects are taken into account to assess tolerance.