NCT02283671已完成1 期
Treatment of Multiple Sclerosis and Neuromyelitis Optica With Regulatory Dendritic Cell: Clinical Trial Phase 1 B
Sara Varea2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- number of patients with adverse events
研究概览
简要总结
First in human study to assess the tolerability and safety profile of treatment with dendritic cell in patients with multiple sclerosis or neuromyelitis optica.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with Multiple sclerosis or neuromyelitis optica
- •diagnosed more than a year before inclusion
- •Expanded Disability Status Scale between 3.0 and 8.5
- •all subtypes of multiple sclerosis or Neuromyelitis optica
- •Multiple Sclerosis patients who have previously been offered therapeutic alternatives available in indications and either decline or that after receiving treatment for at least 6 months have had an outbreak or an increase of at least 1 point on the Expanded Disability Status Scale (EDSS) (non-responders) or who have not tolerated treatment
- •Patients with Neuromyelitis optica (NMO) in stable immunomodulatory treatment in the past 6 months or without treatment because they are not candidates to receive it
排除标准
- •Corticosteroid treatment in the last 30 days
- •Presence of an outbreak in the last month
- •Inability to perform brain Magnetic resonance imaging (with paramagnetic contrast)
- •Serious systemic diseases, including Hepatitis B virus, Hepatitis C Virus, and Human Immunodeficiency Virus. Uncontrolled hypertension, insulin-dependent diabetes mellitus, heart disease or kidney failure or severe respiratory
- •Personal history of cancer or family history of known hereditary cancer
- •patient participating in other experimental study in the last 3 months
- •women childbearing-aged that do not use effective contraceptive methods
- •pregnant or breastfeeding women
结局指标
主要结局
number of patients with adverse events
时间窗: after 12 weeks of follow up
次要结局
- Expanded Disability Status Scale(after 12 weeks of follow up)
- Multiple Sclerosis Functional Composite scale(after 12 weeks of follow up)
- EuroQol5D(after 12 weeks of follow up)
- SF36 Health Status questionnaire(after 12 weeks of follow up)
- Changes in immunological profile(after 12 weeks of follow up)
- number of disease outbreaks(after 12 weeks of follow up)
- Multiple Sclerosis Spasticity Scale(after 12 weeks of follow up)
研究者
Sara Varea
Clinical Research Manager
Fundacion Clinic per a la Recerca Biomédica
研究点 (2)
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