EUCTR2006-002562-19-IT进行中（未招募）不适用
Immunoablation with Cyclophosphamide at high dosage and Rabbit antithymoglobulin followed by autologous hematopoietic stem cell transplantation in severe multiple sclerosis - LIGHT
Dipartimento di Neuroscienze Oftalmologia e Genetica DINOG - Universita di Genova0 个研究点目标入组 12 人开始时间: 2007年1月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age between 18 and 50 Clinically and laboratory definite RRMS or RP EDSS score between 3 and 6.5 Documented rapid progression over the previous year despite conventional therapies immunomodulating and immunosuppressive treatments, see below; progression is defined as a worsening of 1 or more EDSS points between 3 and 6 or 0.5 or more between 6 and 6.5 or at least three relapses in the previous year also without progression of the disease despite conventional therapies immunomodulating and immunosuppressive treatments, see below Presence of at least 1 enhancing area on brain MRI using a triple dose TD of Gd Previous treatment with immunomodulating drugs interferon beta or glatiramer acetate without efficacy Previous treatment with immunosuppressive drugs Mitoxantrone or CY at standard dosage without efficacy Acceptance of using a valid birth control
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Primary progressive or Secondary Progressive MS Relapse in the last 30 days Previous treatment with TBI or TLI Treatment with Interferons, Cop1 or steroids in the last month Treatment with CY, Mitoxantrone, Aza, or other immunosuppressant in the last 3 months Concomitant diseases of lungs, kidneys, liver, heart, endocrine or neurological systems, Infectious illnesses, Psychiatric disturbances Left ventricular ejection fraction 50 , unexplained ECG abnormalities History of recurrent urinary tract infections or respiratory infections Pregnancy, breast feedings, patient s non compliance to use birth control methods Contraindications for MRI
研究者
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