Clinical Trial: A Trial for Evaluating Both Safety and Preliminary Efficacy of a Single Infusion of Stimulated Autologous CD4+T Cells in Patients With Relapsing- Remitting Multiple Sclerosis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Clinical Trial to Document Safety and Radiological Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis Treated With Autologous CD4+ T Cells, Stimula

Brief Summary:

The purpose of this study is to assess the safety and the preliminary efficacy of a single infusion of stimulated autologous CD4+ T cells in patients with Relapsing-Remitting Multiple Sclerosis.

The study duration for the patients (from start of baseline to end of follow-up) is 270 days.


Detailed Summary:
Sponsor: ImCyse

Current Primary Outcome:

  • Safety of the cell based immunotherapy (Adverse events) [ Time Frame: 6 months ]
    Adverse events
  • Safety of the cell based immunotherapy (Vital signs) [ Time Frame: 6 hours ]
    Vital signs
  • Safety of the cell based immunotherapy (Physical examination) [ Time Frame: 6 months ]
    Physical examination
  • Safety of the cell based immunotherapy (Laboratory parameters) [ Time Frame: 6 months ]
    Laboratory parameters
  • Safety of the cell based immunotherapy (MRI) [ Time Frame: 6 months ]
    MRI


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • MRI derived parameters [ Time Frame: 3 months before the day of administration of the investigational medicinal product, the day of administration, 45, 90, 135 and 180 days after the administration ]
    • Cumulative number and mean number per scan of active inflammatory lesions
    • Cumulative number and mean number per scan of new lesions
    • Cumulative number and mean number per scan of enlarged lesions
  • Expanded Disability Status Scale (EDSS) [ Time Frame: 3 months before the day of administration of the investigational medicinal product, the day of administration, 45, 90, 135 and 180 days after the administration ]
  • Clinical relapses [ Time Frame: 3 months before the day of administration of the investigational medicinal product, the day of administration, 45, 90, 135 and 180 days after the administration ]
  • Circulating MOG specific cytolytic CD4+ cells [ Time Frame: 3 months before the day of administration of the investigational medicinal product, the day of administration, 45, 90, 135 and 180 days after the administration ]
  • Circulating anti-MOG antibodies [ Time Frame: 3 months before the day of administration of the investigational medicinal product, the day of administration, 45, 90, 135 and 180 days after the administration ]


Original Secondary Outcome: Same as current

Information By: ImCyse

Dates:
Date Received: April 2, 2015
Date Started: January 2015
Date Completion: August 2016
Last Updated: August 4, 2016
Last Verified: August 2016