Safety and Efficacy Investigation of Patients With Parkinson's Disease by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes of the Unified Parkinson's Disease Rating Scale (UPDRS)
研究概览
简要总结
This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in Parkinson's disease.
详细描述
Parkinson's disease (PD) is a neurodegenerative movement disorder，which mainly shows up in the elderly. And there is as yet no effective drug treatment. Umbilical cord derived mesenchymal stem cells (UC-MSCs) derived from mesoderm owns strong proliferation ability and multiple differentiation potential. The investigators used UC-MSCs via intravenous infusion to treat PD. With different durations of follow-up, the investigators cleared therapeutic effect, the quality of life and prognostic implications of UC-MSCs on PD through the Unified Parkinson's Disease Rating Scale (UPDRS), revised Hoehn-Yahr（H-Y） staging, Mini-Mental State Examination (MMSE), Hamilton depression scales 24 (HAMD 24), Hamilton Anxiety Scale 14 (HAMA 14) and Clinical Global Impression (CGI). In this research, the investigators seek new therapeutic approaches for PD, and provide clinical evidences for the clinical application of UC-MSCs in the future.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 40 to 60 years, and no limitation of gender.
- •Diagnosis of primary Parkinson's disease(PD) according to Movement Disorder Society (MDS)-PD criteria established in
- •Hoehn-Yahr Stages from I to IV stage.
- •Drugs for anti Parkinson's disease have been taken over 28 days before entering the group.
- •MMSE score≥25
- •No antidepressant or antipsychotic drugs were received within 2 weeks.
- •Understanding and willingness to sign a written informed consent document.
排除标准
- •Patients with PD have to be disqualified from this study if any of the following is applicable.
- •Patients with psychiatric history, but depression.
- •Suicidal tendency or behavior of patients.
- •Patients with severe cognitive impairment, chronic organ failure or malignant tumor.
- •The value of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) was 1.5 times higher than that of the normal reference; or leucocyte count<1000/μl.
- •Pregnancy and lactating women.
- •The patient is taking part in other drug tests, or received other research medication within 90 days before entering the group.
- •Patients who had quit our study could not enter it again.
研究组 & 干预措施
mesenchymal stem cells
Selected patients with Parkinson's disease were randomly divided into a therapy group and a control group. Umbilical Cord Derived Mesenchymal Stem Cells(UC-MSCs) at a dose of 10-20 million by intravenous infusion.Patients in the therapy group treated once a week with UC-MSCs. Each course of treatment Lasted 3 weeks.
干预措施: mesenchymal stem cells (Biological)
结局指标
主要结局
Changes of the Unified Parkinson's Disease Rating Scale (UPDRS)
时间窗: Post cell transplantation: 1, 3, 6, 12months
The UPDRS was assessed to identify the severity of PD. It includes the four-scale structure with a reorganization of the various subscales. This four-scale structure are (Part I) nonmotor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
次要结局
- Changes of in the Hoehn and Yahr staging(Post cell transplantation: 1, 3, 6, 12months)
- Adverse reaction(Post cell transplantation: 1, 3, 6, 12months)
- Changes of the Mini-Mental State Examination (MMSE)(Post cell transplantation: 1, 3, 6, 12months)
- Changes of the Hamilton Anxiety Scale 14 (HAMA-14)(Post cell transplantation: 1, 3, 6, 12months)
- Changes of the Hamilton depression scales 24 (HAMD 24)(Post cell transplantation: 1, 3, 6, 12months)
研究者
Shengjun An
Principal Scientist & Professor
Hebei Newtherapy BIo-Pharma technology Co., Ltd.