NCT03113162Unknown1 期
Evaluation of the Safety and Efficacy of Reduced-intensity Immunoablation and Autologous Hematopoietic Stem Cell Transplantation (AHSCT) in Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Safety: Adverse Events
研究概览
简要总结
This is a patient-sponsored study that evaluates the safety and efficacy of reduced-intensity immunoablation followed by a single dose autologous hematopoetic stem cell transplantation in patients diagnosed with multiple sclerosis. Patients are followed-up after 1 month, 3 months, 6 months and 12 months post-transplantation.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with progressive multiple sclerosis with or without relapses
- •EDSS score between 1.5 and 7.0, including documented rapid progression over the previous year unresponsive to conventional therapies or no available treatment options
- •Aged between 18 and 60 with a history of at least one enhancing lesion on brain MRI
- •With absolute neutrophil count ≥ 1,000/mm^3, platelet count ≥ 100,000/mm^3 and hemoglobin ≥ 9.0 g/dL
排除标准
- •Patients with cardiac, renal, pulmonary, hepatic, or other organ impairment that would limit their ability to receive dose-intensive immunosuppressive therapy, high-dose chemotherapy, and/or Autologous HSCT
- •Patients with any active or chronic infection e.g. uncontrolled viral, fungal, or bacterial infection
- •Uncontrolled diabetes
- •Patients who are seropositive for HIV1, HIV2, Hepatitis B Surface Antigen, and Hepatitis C
- •Patients whose life expectancy is severely limited by another illness
- •Patients with evidence of myelodysplasia or other non-autoimmune cytopenia
- •Patients having received a cytotoxic agent within one month prior to this study
- •Patients who are pregnant or at risk of pregnancy, including those unwilling to practice
- •Patients with psychiatric illness, mental deficiency, or cognitive dysfunction
- •Patients unable to give written informed consent in accordance with research ethics board guidelines
研究组 & 干预措施
Autologous Hematopoietic Stem Cell with BEAM Regimen
Experimental
Autologous HSCT following Reduced-Intensity BEAM Regimen
干预措施: Autologous Hematopoietic Stem Cell (Biological)
Autologous Hematopoietic Stem Cell with BEAM Regimen
Experimental
Autologous HSCT following Reduced-Intensity BEAM Regimen
干预措施: BEAM Regimen (Drug)
结局指标
主要结局
Safety: Adverse Events
时间窗: 12 months
Type, occurence, severity, timing, seriousness and relatedness of adverse events and laboratory abnormalities
次要结局
- Efficacy: EDSS Score(1 month post-infusion, 3 months month post-infusion, 6 months month post-infusion, 12 months month post-infusion)
- Efficacy: RAND-36 Score(1 month post-infusion, 3 months month post-infusion, 6 months month post-infusion, 12 months month post-infusion)
研究者
Darwin A. Dasig
Principal Investigator
Makati Medical Center
研究点 (1)
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