NCT01228266终止2 期
Autologous Mesenchymal Stem Cell Transplantation in Multiple Sclerosis: a Randomized, Double-blind, Crossover With Placebo Phase II Study
Albert Saiz2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2010年12月最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- To evaluate the safety as number of severe events along 1 year, and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI at 6 months and at the end of the study
研究概览
简要总结
The study is a randomized Phase II study, masked and crossed-over with placebo to evaluate the safety and tolerability of autologous mesenchymal stem cell transplantation in patients with active multiple sclerosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inflammatory forms of MS
- •Relapsing-remitting MS (RRMS) patients
- •Secondary progressive MS (SPMS) patients with continued relapses
- •Primary progressive MS (PPMS) patients with enhancing MRI lesions and positive CSF (oligoclonal banding)
- •Age 18-50 years
- •Disease duration >= 2 and >= 10 years
- •EDSS 3.0 - 6.5
- •Progression, continued relapses or worsening MRI after at least a year of attempted therapy evidenced by:
- •Increase of >= 1 EDSS point (if baseline EDSS <= 5.0) or 0.5 EDSS points (if baseline EDSS >= 5.5), or quantifiable, objective evidence of equivalent progression
- •>= 1 moderate-severe relapses in past 18 months
- •>= 1 Gadolinium enhancing lesions (double or triple dose Gadolinium)
- •>= 1 new T2 lesion
- •For PPMS only, >= 1 Gadolinium enhancing lesions
- •Has given informed consent to participate in the study.
排除标准
- •SPMS without ongoing relapses
- •PPMS without positive CSF or Gadolinium enhancing lesions
- •<= 3 months since treatment with any immunosuppressive therapy
- •<=1 month since last treatment with interferon-B or glatiramer acetate
- •Corticosteroid treatment <= 30 days
- •Relapse <= 60 days
- •History of cancer or clinical or laboratory results indicative of severe systemic diseases, including infection for HIV, Hepatitis B or C
- •Any metallic or electronic device that precludes from undergoing MRI
- •Pregnancy or lactation
- •Current treatment with an investigational therapy
结局指标
主要结局
To evaluate the safety as number of severe events along 1 year, and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI at 6 months and at the end of the study
时间窗: 12 months
The coprimary endpoints were safety and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI
次要结局
- To evaluate effects on MS disease activity measured by: clinical variables, MRI, OCT, immunological analysis and quality of life scales(12 months)
研究者
Albert Saiz
MD
Hospital Clinic of Barcelona
研究点 (2)
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