A Pilot Study to Assess microRNA Biomarkers in Early and Later Stage Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- To characterize differences in microRNA profile and cell product patterns between early and later stage multiple sclerosis.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
To characterize differences in microRNA profile and cell product patterns between early and later stage multiple sclerosis.
时间窗: baseline
次要结局
- Correlate microRNA profiles with clinical and CSF inflammation indexes(baseline)
研究者
John F. Foley, MD
President and Sponsor-Investigator
Rocky Mountain MS Research Group, LLC