An observational study in Multiple Sclerosis, sponsored by Assiut University. Not yet recruiting. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-10-12.
Sponsored by Assiut University · Observational
Multiple sclerosis (MS) is an autoimmune neurodegenerative disease characterized by demyelination and neurodegeneration of the central nervous system (CNS) . Current diagnostic criteria and management depend on MRI, clinical status, and oligoclonal immunoglobulin g bands . These markers often fail to predict relapse, progression and therapy response .There is an increased need to identify biomarkers for clinical endpoints .
One of the hallmark features of MS is axonal damage which associated with brain and cervical atrophy.Nf levels indicate the extent of axonal damage. Neurofilaments are composed of four subunits: neurofilament light polypeptides (NfL) is the most abundant and soluble and it is highly sensitive to neurodegenerative processes .
Chitinase 3-like 1 (CHI3L1) is expressed in astrocytes in the brain tissue of MS patients . CHI3L1 plays a role as prognostic biomarker in patients with MS. CHI3L1 cerebrospinal fluid levels were associated correlated with disease activity and neurological disability.
Dendritic cells (DCs) are highly specialized antigen-presenting cells with a key role in activating and preventing CNS immune-mediated damage in MS . Dendritic cells express Human Leukocyte Antigen-antigen D Related (HLA-DR) . Plasmacytoid dendritic cells characterized by the expression of blood dendritic cells antigen-2 (BDCA-2) .Plasmacytoid dendritic cells are present in the cerebrospinal fluid (CSF), leptomeninges and demyelinating lesions of patients with MS . Plasmacytoid dendritic cells also exhibit up-regulation of chemokine (CCR7C) expression. It was demonstrated increased amounts of chemokine CCR7 in the CSF from MS patients during relapses .CCR7 controls migration and functional activity of regulatory T cells and plays an important role in the establishment of tolerance .
Tolerogenic DCs (TolDCs) present an intermediate phenotype between immature dendritic cells (iDCs) and mature dendritic cells (mDCs) regarding costimulatory molecules, a pronounced shift toward anti-inflammatory . TolDCs exhibit tolerogenic molecules such as HLA-G and CD274 [programmed death-ligand 1 (PD-L1)] either in peripheral blood or in CSF. These characteristics lead to T cell clonal anergy and T cell unresponsiveness due to Ag presentation in the presence of low co-stimulation .We aim to investigate the role of NfL,(CHI3L1) and markers of plasmacytoid dendritic cells in MS.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's planned enrollment of 42 is below the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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21 MS patients and 21 non-MS control perons.
Inclusion Criteria: 1-MS patients diagnosis 2017 McDonald criteria. 2-Patients age 20-60 years 3-All males and female patients. 3-Willingness and ability to comply with the protocol. 4-Written informed consent given by the patient before the beginning of any study-related procedure, 5-Non-MS control matched age and sex persons
Exclusion Criteria:1-patients with Intracranial space-occupying lesion. 2-Abnormal intracranial pressure due to increased CSF pressure or Arnold-Chiari malformation.
3-Anticoagulant medication, coagulopathies and uncorrected bleeding diathesis. 4-Congenital spine abnormalities. 5-Local skin infection at the puncture site. 6-Not fulfill Macdonald criteria.
MS patients according to 2017 Macdonald criteria
Diagnostic Test: Neurofilament Light Chain ,Chitinase-3 Like-1 Protein Levels and Tolerogenic plasmacytoid Dendritic Cells
Control persons
Diagnostic Test: Neurofilament Light Chain ,Chitinase-3 Like-1 Protein Levels and Tolerogenic plasmacytoid Dendritic Cells
1. Serum and CSF levels assay of NfL and CHI3L1 using the enzyme linked immunosorbent assay kits (ELISA). 2. Peripheral blood mononuclear cells (PBMC) will be obtained by Ficoll-Hypaque gradient. plasmacytoid dendritic cells will be identified in (CSF) and (PBMN) based on their selective expression of surface antigen (cluster of differentiation 303) CD303, named blood dendritic cells antigen 2 (BDCA-2).Antihuman antibodies: BDCA-2, HLA-DR , CD274 , HLA-G and CCR7 for identification of tolerogenic plasmacytoid dendritic cells using flowcytometry.
Levels of different markers in MS diagnosis
The changes of levels of NfL and CHI3L1 using ELISA kits and its correlation with the expression of identification markers of plasmacytoid dendritic cells and its activity (HLA-DR, BDCA-2, ,CCR7C ,HLA-G and CD274) using flowcytometry in different clinical presentations of MS in consistent with MRI findings.
Time frame: 2 years
Different samples levels in MS diagnosis
Changes of levels of NfL and CHI3L1 using ELISA kits and markers of plasmacytoid dendritic using flowcytometry between blood and CSF samples of MS diagnosis.
Time frame: 2 years
No study locations are listed for this record.
Plan to share: Undecided
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Assiut University