Molecular Analysis of Adult Human-derived Neural Stem Cells
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Neuronal differentiation into dopaminergic neurons
研究概览
简要总结
The aim of this study is to develop and optimize methods to isolate, propagate and differentiate adult human neural stem cells from patients with degenerative neurological disorders like Parkinson's disease.
详细描述
In this project the investigators propose to analyze tissue samples from different nervous system regions obtained during neurosurgical procedures in order investigate the presence of neural stem cells in different cerebral areas. The investigators will also evaluate techniques for neural stem cell cryopreservation, for possible future therapeutic uses. Patients with degenerative neurological disorders like Parkinson's disease undergoing neurosurgical procedures meeting our selection criteria will be candidate for this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 or neurodegenerative disorder undergoing a neurosurgical procedure
- •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
Neuronal differentiation into dopaminergic neurons
时间窗: 6 months
Differentiation of at least 10% of dopaminergic neurons is targeted as the primary outcome measure
次要结局
未报告次要终点
研究者
Michel F. Levesque, MD
Principal Investigator
NeuroGeneration