The Precise Transplantation of Human Amniotic Epithelial Stem Cells Into the Ventricle Through Surgical Robot in the Treatment of Parkinson's Disease.
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of participants with adverse event (AE), serious adverse event(SAE) and adverse events of special interest(AESI)
研究概览
简要总结
The purpose of this study is to evaluate the safety of multiple treatments of hAESCs treatments, while exploring the effectiveness of hAESCs treatments for PD.
详细描述
The study plans to use randomized controlled trial and recruit 12 participants with Idiopathic Parkinson's disease. The trial will be divided into two groups, hAESCs treatment group and control group, each group 6 subjects. Through surgical robot technology, hAESCs will be precisely multiple transplanted into the lateral ventricles, that is two times consolidation hAESCs treatments or placebo were added to the four times basic hAESCs treatments. Therapeutic safety and effectiveness of multiple treatments of hAESCs on PD will be evaluated to further develop the optimal stem cell treatment strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 more than 5 years primary Parkinson's disease history, male or female;
- •The "off-age" UPDRS exercise score is between 38 and 70 points, two times before the operation, the "down period" UPDRS exercise score was stable, that is, (high value - low value) / high value ≤ 10%;
- •The Parkinson treatment is stable for more than 3 months;
- •Levodopa treatment was effective;
- •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 the cranial MRI;
- •Patients shall be properly cared during treatment, and caregivers can provide transplantation situations and 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;
- •"off period" or "on period" has 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);
- •Injecting apomorphine treatment;
- •Abnormal blood coagulation 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 prophylactic anti-epileptic drugs;
- •Alcohol or drug abuse;
- •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;
- •Malignant tumor or active infection within 5 years;
- •Serum virology showed positive results for hepatitis C virus (HCV) , treponema pallidum (TP) or HIV; Active hepatitis B (hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) positive, and peripheral blood HBV DNA titer ≥1×10^3 IU/ mL);
- •Abnormal liver and kidney 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 conditions considered ineligible for inclusion by the investigator.
结局指标
主要结局
Number of participants with adverse event (AE), serious adverse event(SAE) and adverse events of special interest(AESI)
时间窗: 12 Months
AE occurring throughout the study period will be evaluated using the CTCAE V5.0 standard. AE/SAE and AESI were evaluated after Ommaya sac installation by laboratory examination, measurement of vital signs, physical examination, and subjects' symptoms to detect new abnormalities and/or deterioration of previous conditions and evaluate the safety of the study. AESI is defined as intracranial infection, hemorrhage, rejection, and edema within 7 days after Ommaya sac installation, as well as acute allergic reactions and ectopic mass formation associated with study therapy.
次要结局
- Differences in biochemical indicators of cerebrospinal fluid(day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.)
- Changes in Unified Parkinson's Disease Rating Scale (UPDRS) in OFF state between the experimental group and the control group at 12 months after the first hAESCs treatment(day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.)
- Glucose metabolism measured by 18F-Fluoro-2-deoxy-glucose (FDG) PET scan(4 month, 6 month, 12 month)
- Changes in the Schwab and England score(day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.)
- Changes in the Hamilton Depression (HAMD) Scale(day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.)
- Cranial dopamin transporter measured by positron emission tomography (PET)- magnetic resonance imaging (MRI)(4 month, 6 month, 12 month)
- Changes in the Hoehn and Yahr scale(day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.)
- Changes in the Parkinson's Disease Questionnaire (PDQ-39)(day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.)