NCT00220428Unknown1 期
The Effect of T-Cell Vaccination in Multiple Sclerosis - Phase I/II Safety and Efficacy Trial
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- safety assessment of T-cell vaccination in nonresponding MS patients
研究概览
简要总结
The purpose of this study is to evaluate the safety of T-cell vaccination in MS patients.
详细描述
Immunization of MS patients with irradiated autologous encephalitogenic myelin peptides (EMP) specific T-cell lines or clones.
Clinical immunologic and neuroradiologic evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Educational Counseling Training
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite MS (post criteria)
- •Relapsing remitting or primary progressive clinical course. At least one relapse in the last two years.
- •Disease duration > 1 year
- •Expanded Disability Status Scale (EDSS) between 0-6
- •Brain magnetic resonance imaging (MRI) compatible with MS
- •Not involved in any other clinical trials
- •No other systemic disease
排除标准
- •Does not comply with the above
结局指标
主要结局
safety assessment of T-cell vaccination in nonresponding MS patients
次要结局
未报告次要终点
研究者
研究点 (1)
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