Ignite Creation Date:
2024-05-06 @ 3:11 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02225977
Status:
COMPLETED
Last Update Posted:
2018-08-22
First Post:
2014-08-24
Brief Title:
Assessing Induction of Type II M2 MonocytesMacrophages in Patients Receiving Gilenya
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Assessing Induction of Type II M2 MonocytesMacrophages in Patients Receiving Gilenya
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study we wish to test the hypothesis that continuous Gilenya treatment alters immune homeostasis in favor of an anti-inflammatory type II monocyte and macrophage M2 phenotype in the circulation of patients with relapsing-remitting Multiple Sclerosis MS In this study we will determine the change in ratio of M2 type II alternatively activated versus M1 type I classically activated monocytes and macrophages in a cohort of patients that have received continuous Gilenya treatment for 0 1 3 6 or 12 months We will also assess changes in cell surface expression of the M1 marker CCR7 and the M2 markers CD206 or CD301 by monocytes and macrophages using FACS analysis of whole blood and assess the tyrosine phosphorylation of the signal transducer and activator of transcription STAT-1 pTyr-STAT1 which is critical for the activation of M1 myeloid cells We will assess correlates with changes in M1 and M2 cytokine expression assessing possible mechanisms of action of Gilenya on myeloid lineage cells
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None