A Pilot Study to Assess microRNA Biomarkers in Early and Later Stage Multiple Sclerosis

Study Overview
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Brief Summary
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This study will look at the blood and cerebrospinal fluid of consented participants who either have early stage multiple sclerosis (clinically isolated syndrome) or who have later stage (secondary progressive multiple sclerosis), or participants who do not have any neurological or autoimmune illness. Biomarkers and microRNA will be assessed for group differences.

Detailed Description
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Multiple Sclerosis is a chronic autoimmune disorder of the central nervous system. While there are current immunomodulatory therapies that have been shown to be efficacious in the early stages of MS, these therapies are less potent in the later phases of MS. We can look at magnetic resonance imaging with gadolinium to measure active disease but it does not detect axonal degeneration. Therefore, there is a need to identify other biomarkers that may be used to diagnose MS and predict disease progression. Biomarkers found in the cerebrospinal fluid (CSF) are in closer proximity to the inflammatory lesion sites and are more sensitive. This pilot study seeks to characterize differences in microRNA profiles and cell products in the early and later stages of MS, with the hope that that microRNA profiles could then be correlated to clinical and CSF inflammation indexes. CSF will be obtained from 45 participants.

Official Title
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A Pilot Study to Assess microRNA Biomarkers in Early and Later Stage Multiple Sclerosis

Conditions
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Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Clinically Isolated Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: able to understand and agree to informed consent; male or female patients 18-68 years of age no disease modifying therapy 60 days prior to Baseline EDSS score of less than or equal to 3.0 if a CIS patient; or less than or equal to 7.5 if SPMS patient Labs within normal range no greater than 2 times the ULN or at the discretion of the PI weight 46 kilograms to 127 kilograms inclusive no active systemic infection not currently pregnant or breast feeding no history of corticosteroid treatment or relapse within 60 days prior to Baseline. Exclusion Criteria: not able to understand informed consent if any of the inclusion criteria is not met HIV infection, or current active Hepatitis B or C infection, positive HCVAb or HBsAG or HBcAB positive pregnancy test patient withdraws consent Coumadin use within 60 days prior to Baseline

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Secondary Progressive MS (SPMS)<br>Secondary Progressive MS participants | |
| Clinically Isolated Syndrome (CIS)<br>Clinically isolated syndrome participants | |
| Healthy participants<br>No immunological or neurological illnesses. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize differences in microRNA profile and cell product patterns between early and later stage multiple sclerosis. |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate microRNA profiles with clinical and CSF inflammation indexes |  | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Clinically Isolated Syndrome