Investigator Clinical Trial for Evaluation of Safety and Tolerability After Transplantation of Fetal Mesencephalic Dopamine Neuronal Precursor Cells in Patients With Parkinson's Disease
试验速览
- 阶段
- 1 期
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Presence or absence of cancer foramtion and infection
研究概览
简要总结
The purpose of clinical trials is to evaluate safety and tolerability of Fetal Mesencephalic Dopamine Neuronal Precursor Cells as a treatment for Patients with Parkinson's disease.
详细描述
This study is phase I/II clinical trials which is accessible to those involved in the study and conducted by only Bundang CHA hospital.
The progress of the clinical trails is reported to and evaluated by Data monitoring committee before the enrolment of next human subject.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients with idiopathic or primary Parkinson's disease
- •Hoehn and Yare (HY) stage III or IV
- •more than 33% improvement Part III UPDRS score after one injection of levodopa in the morning
- •Patients aged less than 70
- •Great decrease of dopamine uptake in putamen, particularly posterior part, in Positron emission tomograph(PET) before surgery
排除标准
- •Atypical or secondary parkinsonism
- •Medical history of severe depression with Beck Depression Inventory(BDI) scores greater than 30
- •Psychological disorders (illusion, delusion, schizophrenia)
- •Dementia with K-MMSE(Korean mini-mental state examination) scores less than 24
- •Medial history of brain surgery
- •Medical history of other brain diseases
- •Hemorrhagic tendency
- •Severe internal diseases such as poor general condition, hypertension, chronic respiratory disease, ischemic heart disease, cancer
- •Experience of participating in clinical trial within 30 days
- •Female patients who have the chances of getting pregnant during clinical trial and do not use the approved birth controls
- •Pregnant or lactating women
- •Patients who are not considered to be eligible to participate in clinical trial
研究组 & 干预措施
Mesencephalic Neuronal Precursor Cells
干预措施: Mesencephalic Neuronal Precursor Cells (Drug)
结局指标
主要结局
Presence or absence of cancer foramtion and infection
时间窗: 5 years
If not included in the following criteria, the cells are are considered to be safe and tolerable. * Cells with grade 3 or more in NCI grading system * Cells contaminated with infectious materials * Cells with risk of cancer formation
次要结局
- Score of Unified Parkinson's Disease Rating Scale (UPDRS)(5 years)
- Detection of positron emission in Putamen using Positron emission tomograph(PET)(5 years)
- Dyskinesia scale scores(CAPSIT-PD)(5 years)
- Pronation-supination test, Hand/Arm movement between two points, finger dexterity, stand-walk-sit-test(5 years)
- Score of activity of daily living (ADL) scale(5 years)
- Score of Korean mini-mental examination (K-MMSE)(5 years)
- Motor fluctuation scale scores(5 years)
- Satisfaction score with patient questionnaire(5 years)
- Dopaminergic drug dose(5 years)
- Tremor, postural instability, motor dysfunction, gait disturbance(5 years)
- Assessing the extent of recovery with patient's diary(5 years)
研究者
Sang Sup Chung
Professor
Bundang CHA Hospital