A Pilot Study to Assess microRNA Biomarkers in Early and Later Stage Multiple Sclerosis
研究概览
地位
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Utah
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Salt Lake City、Utah、美国、84103
- Rocky Mountain MS Clinic
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
45 participants will be enrolled into a study to examine the microRNA and cell products profile in both cerebrospinal fluid (CSF) and blood. Study population will consist of a total of: 20 CIS patients defined as patients having a single attack (or the appearance of one or more symptoms characteristic of MS) high risk of developing MS, when no other diseases or causes are apparent.
20 SPMS patients 5 normal, non-diseased controls
描述
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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Secondary Progressive MS (SPMS)
Secondary Progressive MS participants
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Clinically Isolated Syndrome (CIS)
Clinically isolated syndrome participants
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Healthy participants
No immunological or neurological illnesses.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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To characterize differences in microRNA profile and cell product patterns between early and later stage multiple sclerosis.
大体时间：baseline
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baseline
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次要结果测量
结果测量 |
大体时间 |
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Correlate microRNA profiles with clinical and CSF inflammation indexes
大体时间：baseline
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baseline
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合作者和调查者
调查人员
- 首席研究员：John F Foley, MD、Rocky Mountain MS Research Group, LLC
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 003-001-GEN
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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