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