Preliminary Study for Selective Detection of the CD8+ Myelin Specific T Cell in the Blood of Multiple Sclerosis Patients (MS).
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- University Hospital, Bordeaux
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Analysis of pentamers (> 0,1 % of the CD3 + CD8 + T-cells) will be statistically compared between the 3 groups of patients.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
Most experts in the field consider Multiple Sclerosis as the main auto immune disease of the central nervous system. In spite of many works, the data in the literature concerning the antigens targeted by the CD8+ T-Cell response are still contradictory and insufficient.
Detailed Description
30 patients distributed in 3 groups of 10 patients with specific inclusion criteria will participate in this trial: * 10 MS patients in early disease onset, * 10 MS patients under Natalizumab treatment * and control group of 10 patients with other neurological diseases. The aim of this clinical trial is to detect the CD8+ myelin specific T-Cells in the blood of Multiple Sclerosis patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Group 1: HLA-A2 patients whose Multiple Sclerosis has just been diagnosed
- •18 year old and older patients,
- •HLA-A2 Patients with Multiple Sclerosis or clinically isolated syndrome at high risk of being affected by Multiple Sclerosis (criteria of spatial scattering according to the 2010 or 2005 McDonald's criteria)
- •Patients without treatment or treated with immunomodulating therapy
- •Patients affiliated to health insurance coverage
- •Information and comprehensive agreement signed by the patient and the investigator
- •Group 2: HLA-A2 patients hospitalized in the neurology department who are not affected with a neuroimmunological disorder
- •18 year old and older patients,
- •HLA-A2 patients hospitalized in the neurology department
- •Patient not affected by Multiple Sclerosis or a related inflammatory disorder
Exclusion Criteria
- •Group 1 and 3:
- •Patients undergoing immunosuppressive therapy at present or in the past except Natalizumab
- •Pregnant women
- •Patients undergoing immunosuppressive therapy at present or in the past
- •Patients affected by Multiple Sclerosis or a related disorder
- •Pregnant women
Outcomes
Primary Outcomes
Analysis of pentamers (> 0,1 % of the CD3 + CD8 + T-cells) will be statistically compared between the 3 groups of patients.
Time Frame: 6 months after the inclusion
This analysis will enable us to detect CD8+ myelin specific T-cells in the blood of Multiple Sclerosis
Secondary Outcomes
- The results will be correlated with the patients MRI data(6 months after the inclusion)
- The results will be correlated with the patients clinical(6 months after the inclusion)
- Description of lymphocyte immunophenotyping and dosage of immunoglobulins in patients treated with Natalizumab(6 months after the inclusion)