NCT01056471已完成1 期
Multicenter Clinical Trial Phase I / II Randomized, Placebo-controlled Study to Evaluate Safety and Feasibility of Therapy With Two Different Doses of Autologous Mesenchymal Stem Cells in Patients With Secondary Progressive Multiple Sclerosis Who do Not Respond to Treatment
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年1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
- 30
- 试验地点
- 4
- 主要终点
- To evaluate safety and tolerability related to the intravenous infusion of autologous mesenchymal stem cells
研究概览
简要总结
The main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with mesenchymal stem cells from adipose tissue, administered intravenously in patients with secondary progressive multiple sclerosis who do not respond to treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Multiple Sclerosis (Poser and McDonald criteria).
- •Secondary progressive MS patients with EDSS ≥ 5.5 and ≤
- •Patients with treatment failure defined by: no response to immunomodulators / immunosuppressants, and showing activity in the form of 1 relapse in the last year or 0.5 points in EDSS progression.
- •Patients with no MS relapse and no steroid treatment within the month prior to inclusion.
- •Patients who give written consent to participate in the study. -
排除标准
- •History of current pathology or current laboratory results indicative of any severe disease.
- •Pacemaker or metallic implants that prevent MR imaging.
- •Inability to complete questionnaires.
- •Refusal to give informed consent.
- •Predicted impossibility for a biopsy of at least 30 grams of fat tissue.
- •Positive screening test for HIV, Hepatitis B or Hepatitis C.
- •History of malignancy.
- •Having been in treatment with any investigational drug or have undergone any experimental procedure in the 3 months prior to baseline.
- •Body mass index> 40 kg/m
- •Patients who have been treated with prohibited concomitant medication during the month prior to inclusion in the study.
- •Pregnancy or lactation
结局指标
主要结局
To evaluate safety and tolerability related to the intravenous infusion of autologous mesenchymal stem cells
时间窗: 12 months.
次要结局
- To evaluate effects on MS disease activity measured by: clinical variables, imaging variables, immunological and neurophysiologic analysis, neuropsychological and quality of life scales.(12 months)
研究者
研究点 (4)
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