NCT03815071Unknown早期 1 期
Clinical Study of the Safety and Efficacy of Autologous Neural Stem Cells in the Treatment of Parkinson's Disease
Allife Medical Science and Technology Co., Ltd.0 个研究点目标入组 10 人开始时间: 2019年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 10
- 主要终点
- occurrence of treatment related adverse events
研究概览
简要总结
This is a single center, single arm and open-label study to investigate the safety and efficacy of iPS-NCS with Parkinson's Disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •The subject is able to understand the research requirements, provide written informed consent, and complete the study in accordance with the procedures;
- •The subject is clearly diagnosed with Parkinson's;
- •Recorded disease progression over the past 6 months;
- •Vital organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥ 50%, no obvious abnormality in ECG; blood oxygen saturation ≥ 90%; creatinine clearance calculated by Cockcroft-Gault formula ≥ 40ml/min; ALT and AST ≤ 3 times the normal range, total bilirubin ≤ 2.0 mg/dl;
- •Blood routine: Hgb≥80g/L, ANC≥1×109/L, PLT≥50×10/L;
排除标准
- •Mental illness or a neurological disease not associated with Parkinson's disease;
- •Serious other concomitant diseases (tumor, organ failure, etc.);
- •Subjects used a large amount of corticosteroids, immunoglobulins, immunosuppressants before entering the study;
- •Participated in other clinical trials of cell preparations and participated in other clinical trials within 3 months;
- •There are already cognitive impairments or depressions, etc., and the research cannot be completed well;
- •Female subjects who are breast-feeding or have a pregnancy plan recently.
研究组 & 干预措施
ips-nsc treatment group
Experimental
干预措施: Ips-nsc cells (Drug)
结局指标
主要结局
occurrence of treatment related adverse events
时间窗: 1 year
occurrence of treatment related adverse events that are possible, likely. Or definitely related to study treatment.
次要结局
未报告次要终点
研究者
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