Clinical trial NCT06957145: Vista Protein Expression of Monocyte and T Cell Subsets in Multiple Sclerosis and Its Clinical Correlation
Official title: Vista Protein Expression of Monocyte and T Cell Subsets in Multiple Sclerosis and Its Clinical Correlation: A 1-Year Follow-up Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Multiple Sclerosis, MS
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Multiple Sclerosis

Brief summary: The aim of this study is to investigate whether VISTA, a newly identified negative immune regulatory protein, differs in monocytes and T cells of patients diagnosed with Multiple Sclerosis (MS) and Clinically Isolated Syndrome (CIS) compared to the same cell types in healthy controls. Additionally, the potential clinical correlation of VISTA expression in the follow-up of MS and CIS patients will be examined. By elucidating the role of VISTA in the pathophysiology of MS, this study will contribute to the literature by exploring its potential as a biomarker and its relevance in the development of novel therapeutic strategies.

Specifically, this study will compare VISTA protein secretion in MS patients at the time of their first attack with that of healthy controls. Furthermore, changes in VISTA protein secretion will be assessed in blood samples collected at 6- and 12-month follow-ups, and the correlations of these changes with clinical and laboratory findings will be investigated.

Finally, this study aims to determine whether CD4+ and CD8+ T cells, monocytes, and T regulatory (Treg) subgroups in the first attack blood samples of MS patients exhibit similar functional properties in terms of VISTA protein secretion as their counterparts in healthy controls. To achieve this, monocytes and T cell subtypes will be stimulated, and their pro- and anti-inflammatory cytokine responses will be analyzed.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older diagnosed with MS or CIS according to the 2017 McDonald criteria.
* No diagnosis of any autoimmune disease or malignancy.
* No new diagnosis of autoimmune disease or malignancy during the 1-year follow-up period.
* No use of antibiotics, nonsteroidal anti-inflammatory drugs (NSAIDs), or steroid treatments within one month prior to blood sampling.
* No vaccination within one month prior to blood sampling.
* Not in the menstrual cycle at the time of blood sampling.

Exclusion Criteria:

* Age below 18 years.
* Presence of a previous or newly diagnosed autoimmune disease or malignancy at the time of blood sampling.
* Use of antibiotics, nonsteroidal anti-inflammatory drugs (NSAIDs), or steroid treatments within one month prior to blood sampling.
* Vaccination within one month prior to blood sampling
* Being in the menstrual cycle at the time of blood sampling
* Patients without a definitive MS diagnosis according to the 2017 McDonald criteria will not be included in the study.

Primary outcomes:
measure: VISTA Protein Secretion
timeFrame: Baseline, Week 0
Secondary outcomes:
measure: Functional Comparison of Immune Cell Subsets via Cytokine Profiling and VISTA Expression Analysis
timeFrame: Baseline, Week 0
measure: Clinical and Radiological Correlation
timeFrame: Baseline, Month 6, Month 12
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koc University
Study officials:
affiliation: Koç University
name: Rabia G Gozubatik Celik, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: