A Clinical Study on Safety and Effectiveness of Intravenous Infusion Plasma From Healthy Young People to Treat Amyotrophic Lateral Sclerosis
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Amyotrophic lateral sclerosis Functional Rating Scale scores
研究概览
简要总结
To evaluate the safety and effectiveness of intravenous infusion of plasma from healthy young people for the treatment of amyotrophic lateral sclerosis.
详细描述
This is a single-center, open-label clinical study to evaluate the safety and effectiveness of intravenous infusion of plasma from healthy young people for the treatment of amyotrophic lateral sclerosis. The main outcome indicators are the record of adverse reactions and the rate of change of amyotrophic lateral sclerosisFunctional Rating Scale score. The secondary outcome indicators include survival time-time to the end event (death, tracheotomy, continuous ventilator dependence), forced vital capacity (FVC), recognition Knowledge function evaluation (ECAS score).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open Lable
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the following diagnosis standard: confirmed, proposed and laboratory supported diagnosis;
- •Age 50-70 years old ;
- •3-18 months course of disease;
- •Forced vital capacity (FVC) ≥70% predicted value;
- •Total amyotrophic lateral sclerosis Functional Rating Scale score ≥36, scores of respiratory related items ≥10;
- •Take Riluzole regularly before participate in this trial (25~50mg twice a day for at least 30 days continuously) without obvious side effects and can continue to take for 22 months;
- •Participants of childbearing age take reasonable and effective contraceptive measures from the time of enrollment to the end of follow-up;
- •Signed informed consent.
排除标准
- •Familial amyotrophic lateral sclerosis;
- •Female during pregnancy and lactation;
- •Positive hepatitis B, hepatitis C or HIV in screening
- •History of cytomegalovirus and malaria infection;
- •After tracheotomy and ventilator-dependent state (daily use of non-invasive ventilator ≥ 22 hours for 7 consecutive days);
- •After percutaneous gastrostomy (PEG) operation;
- •Has had allergic reactions and other adverse reactions during blood transfusion;
- •Have diseases of the blood system (including Immunoglobulin A deficiency);
- •alanine transaminase, Aspartate transaminase≥ 3 times the upper limit of normal;
- •Abnormal renal function (Cr, BUN);
- •History of malignant tumors;
- •Combining severe cardiopulmonary diseases, autoimmune diseases, mental diseases, substance abuse history, etc;
- •Currently participating in other clinical studies or using other drugs in researching.
研究组 & 干预措施
Biological+Riluzole
Plasma from healthy young people treatment + Riluzole
干预措施: Plasma from healthy young people treatment + Riluzole (Biological)
Riluzole
Riluzole
干预措施: Riluzole (Drug)
结局指标
主要结局
Amyotrophic lateral sclerosis Functional Rating Scale scores
时间窗: 22 months after intervention
Rate of amyotrophic lateral sclerosis Functional Rating Scale scores changes
次要结局
- Survival time(22 months after intervention)
- Forced vital capacity (FVC)(22 months after intervention)
- Cognitive function evaluation (ECAS score)(22 months after intervention)