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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2021

Interventions

  • Biological: Autologous apoptotic cells injection
    • cells injection

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Tolerance of apoptotic cells injection
    • Time Frame: 12 weeks
    • Side effects are taken into account to assess tolerance.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Besancon
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Eric Toussirot, Professor, Principal Investigator, Rhumatology – CHU Besançon
  • Overall Contact(s)
    • Charline Vauchy, PhD, +33381218875, cvauchy@chu-besancon.fr

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