Longitudinal Study of Innate Lymphoid Cells in Peripheral Blood in ALS
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Total number of classical NK (natural killer) cells; total number of CD3+ CD4+ CD8+ cells
研究概览
简要总结
Amyotrophic lateral sclerosis (ALS) is a devastating neurodegenerative disorder characterized by progressive muscle weakness and eventual death. Studies demonstrate that the immune system plays a key role in ALS progression; however, the role of the immune system is unclear, as various aspects can play both a beneficial and detrimental role in the disease course. Attempts to universally suppress the immune system in ALS patients have at best had negligible effects on progression or at worst accelerated the disease. Thus, there is a critical need to identify immune cell populations to serve as biomarkers and therapeutic targets.
详细描述
Application - HUM00107546
Study Title:
Longitudinal Study of Innate Lymphoid Cells in Peripheral Blood in ALS
Full Study Title:
Longitudinal Study of Innate Lymphoid Cells in Peripheral Blood in ALS
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older.
- •Clinically definite, probable, probable laboratory supported, or possible ALS by El Escorial criteria
- •Fluency in English at the 6th grade level or higher.
- •Able to communicate sufficiently well by speaking
- •Able to communicate over the phone.
- •Capable of providing informed consent.
- •Lives geographically accessible to the University of Michigan
排除标准
- •Unable to provide informed consent.
- •Clinically significant dementia, as judged by the site investigator.
- •Other neurological or psychiatric disorders which are expected to impair cognitive function.
- •Other serious and uncontrolled medical disorders.
- •History of autoimmune disease.
- •Use of prednisone, IVIG, or immunosuppression within the last 12 months.
- •Not geographically accessible to the University of Michigan
结局指标
主要结局
Total number of classical NK (natural killer) cells; total number of CD3+ CD4+ CD8+ cells
时间窗: Every 28 days (+/- 5 days) for 12 total visits over 36 months
Total number of classical NK cells; total number of CD3+ CD4+ CD8+ cells
次要结局
- Cytokine expression(Every 28 days (+/- 5 days) for 12 total visits over 36 months)
研究者
Benjamin Murdock
Research Investigator
University of Michigan