Clinical Study of Stereotactic Transplantation of Human Amniotic Epithelial Stem Cells (hAESCs) in the Treatment of Parkinson's Disease (PD)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of Participants with adverse event and serious adverse event
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of stereotactic transplantation of hAESCs for Parkinson's disease.
详细描述
The study plans to recruit 3 participants with Parkinson's disease . Using stereotactic technology, hAESCs will be accurately transplanted into the lateral ventricle. Therapeutic effectiveness and safety of hAESCs on PD will be evaluated. hAESCs are derived from placental amnion donated after cesarean section in healthy women. hAESCs is developed from the epiblast as early as 8 days after fertilization, recent reports indicate that hAESCs have some characteristics of neural stem cell. These cells are able to differentiate into dopaminergic neurons and secrete dopamine and various neurotrophic factors. These HAESCs could be seen as one of the best potential stem cell source for treating 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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30-70 years old, with primary Parkinson's disease more than 5 years, male or female;
- •The "off-stage"Hohen and Yahr grade of Parkinson's disease is from 2 to 4; and the"off-stage"UPDRS score is 38-70, difference between two scores before treatment is less than 10% ;
- •The dosage of medicine is stable for more than 3 months;
- •Levodopa treatment was effective ;
- •Stable condition, good control of complications, no general anesthesia contraindications, no contraindications to stereotactic surgery and other conditions that interfere with clinical evaluation;
- •No abnormalities affecting cell transplantation were found through head MRI;
- •Patients shall be properly cared during treatment, and caregivers can provide assistance to the researcher if necessary.
排除标准
- •Atypical Parkinson's disease, such as Parkinson's syndrome, secondary Parkinson's disease;
- •Only having tremor syndrome;
- •Serious movement disorders and cannot complete any routine exercise tasks;
- •Symptoms of severe neurological deficits caused by other diseases;
- •Severe mental symptoms or dementia;
- •Patients are unwilling to cooperate or incapable of completing self-evaluation, and cannot complete the evaluator with the help of a doctor;
- •History of striatum or extrapyramidal surgery, including deep brain stimulation (DBS);
- •Ongoing treatment of apomorphine injecting ;
- •Coagulation disorders or ongoing anticoagulation therapy;
- •Women of childbearing age who do not take effective contraception;
- •Pregnant or lactation;
- •Patients who have participated in other clinical studies of drugs or medical devices within 3 months;
- •Botox toxin, phenol, subarachnoid injection of baclofen or interventional therapy for the treatment of dystonia or spasticity within 6 months;
- •History of seizures or taking prophylactic anti-epileptic drugs;
- •General anesthesia or stereotactic surgery contraindications, such as sleep apnea, chronic obstructive pulmonary disease;
- •Other circumstances judged by the investigator that may cause negative effect to the subject;
- •Alcohol or drug abuse;
- •Used diazepam within 3 months;
- •Severe cognitive impairment, depression, or behavioral disorder, defined as the Mini-Mental State Assessment Scale (MMSE) of less than 26 points, and the Hamilton Depression Rating Scale (HAMD) of greater than 35 points;
- •Chest CT shows active disease or tumor;
- •Currently suffering from or ever had a tumor other than cutaneous basal cell tumor and cervical carcinoma in situ;
- •The detection of HIV, hepatitis B virus(HBV), hepatitis C virus (HCV), syphilis and other infection indicators before surgery can not exclude HIV and syphilis infection;
- •Abnormal liver and kidney normal function tests in the laboratory, liver and kidney function is defined as Alanine aminotransferase（ALT）, Aspartate aminotransferase（AST） is less than 2.5 times the upper limit of normal, blood urea nitrogen (BUN) and Creatinine（Cr） are less than the upper limit of normal.
- •Other situations not suitable for enrollment judged by investigator
结局指标
主要结局
Number of Participants with adverse event and serious adverse event
时间窗: 12 months
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. A serious adverse event is defined as an adverse event that meets at least one of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other significant medical hazard. Whether an adverse event was treatment-related (TRAE) or not was determined by investigator.
次要结局
- Changes in the Hoehn and Yahr scale(day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.)
- Changes in Parkinson's Disease Questionnaire (PDQ-39)(day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.)
- Cranial doparmin transporter measured by positron emission tomography(PET)-magnetic resonance Imaging(MRI)(4 month, 6 month)
- Glucose metabolism measured by 18F-Fluoro-2-deoxy-glucose (FDG) PET scan(4 month, 6 month)
- Levodopa equivalent daily dose(day 0, 1 month, 2 month, 3 month, 4 month, 5 month, 6 month, 9 month and 12 month.)
- Changes in Unified Parkinson's Disease Rating Scale (UPDRS) in ON and OFF state(day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.)
- Changes in the Schwab and England score(day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.)
- Differences in biochemical indicators of cerebrospinal fluid(day 0, 1 month, 2 month, 3 month, 4 month,5 month,6 month, 9 month and 12 month.)