NCT03309514撤回1 期
Clinical Investigation of Transplantation of Neural Stem Cell-derived Neurons for the Treatment of Parkinson's Disease
NeuroGeneration0 个研究点开始时间: 2022年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- Motor UPDRS
研究概览
简要总结
This is a prospective study to demonstrate the safety and efficacy of differentiated neurons-derived from adult CNS progenitors cells transplanted in selected patients 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to give informed consent prior to study
- •Male or Female with Diagnostic Criteria of Parkinson's disease
- •Age 35 to 85 years old
- •Parkinson's disease not due to trauma, infection, brain tumor, cerebrovascular disease
- •Hoehn and Yahr Stage III or IV
- •Parkinson's disease observed in the absence of:
- •Oculomotor palsy
- •Cerebellar sign
- •Orthostatic hypotension (drop greater than 20mmHg in mean pressure)
- •Pyramidal sign
- •Amyotrophy
- •Good general health or stable medical condition well controlled, without contraindications to anesthesia
排除标准
- •Patients with severe dementia and brain atrophy on MRI
- •Patients with severe hypertension; renal, liver, cardiac or other major organ disease; coagulopathy; cancer; other significant systemic illnesses; hepatitis, HIV
- •Patients older than 85 or younger than 35
- •Patients who withhold informed consent
- •Patients with a history of alcohol or drug abuse
- •Sexually active women of childbearing potential without adequate form of birth control
- •Evidence of abnormal coagulation or anticoagulant therapy
- •Pregnancy or lactation
- •History of seizure disorders or current use of antiepileptic medication
- •Severe cognitive impairment
- •Clinically significant laboratory abnormality
结局指标
主要结局
Motor UPDRS
时间窗: 6 months
UPDRS Motor scale
次要结局
未报告次要终点
研究者
Michel F. Levesque, MD
Principal Investigator
NeuroGeneration
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