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A new method to treat hereditary cerebellar ataxia — umbilical cord mesenchymal stem cells trsplantation
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注册号:

Registration number:

ChiCTR-ONRC-12001869 

最近更新日期:

Date of Last Refreshed on:

2015-07-28 

注册时间:

Date of Registration:

2012-01-09 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

治疗遗传性共济失调的新方法-脐带间充质干细胞移植 

Public title:

A new method to treat hereditary cerebellar ataxia — umbilical cord mesenchymal stem cells trsplantation 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

治疗遗传性共济失调的新方法-脐带间充质干细胞移植 

Scientific title:

A new method to treat hereditary cerebellar ataxia -- umbilical cord mesenchymal stem cells trsplantation 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

李敏 

研究负责人:

安沂华 

Applicant:

Li Min 

Study leader:

An yihua 

申请注册联系人电话:

Applicant telephone:

+86 13581821528 

研究负责人电话:

Study leader's telephone:

+86 18600090033 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

liminde33@sohu.com 

研究负责人电子邮件:

Study leader's E-mail:

riveran@126.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

北京市海淀区永定路69号神经干细胞移植科 

研究负责人通讯地址:

北京市海淀区永定路69号神经干细胞移植科 

Applicant address:

69 Yongding Road, Haidian District, Beijing 

Study leader's address:

69 Yongding Road, Haidian District, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

100039 

研究负责人邮政编码:

Study leader's postcode:

100039 

申请人所在单位:

北京市海淀区永定路69号神经干细胞移植科 

Applicant's institution:

The neural stem cell transplantation department The NO.69, Yongding Road Haidian District Beijing 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

06012011 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

武警总医院伦理委员会 

Name of the ethic committee:

Ethics Committee of General Hospital of Chinese People's Armed Police Force 

伦理委员会批准日期:

Date of approved by ethic committee:

2011-06-01 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

中国人民武装警察部队总医院 

Primary sponsor:

General Hospital of Chinese People's Armed Police Force 

研究实施负责(组长)单位地址:

北京市海淀区永定路69号神经干细胞移植科 

Primary sponsor's address:

69 Yongding Road, Haidian District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

省(直辖市):

市(区县):

Country:

Province:

City:

单位(医院):

中国人民武装警察部队总医院

具体地址:

北京市海淀区永定路69号

Institution
hospital:

General Hospital of Chinese People's Armed Police Force

Address:

69 Yongding Road, Haidian District, Beijing

经费或物资来源:

医院基金 

Source(s) of funding:

The funds from hospital 

研究疾病:

遗传性共济失调 

Target disease:

hereditary cerebellar ataxia 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

II期临床试验 

Study phase:

研究目的:

遗传性小脑共济失调是类常染色体显性遗传的遗传病,病变主要累及小脑,但脊髓及颅神经也可部分受累。临床主要常以共济失调步态为首发症状,各功能肌肉组力量以及协调障碍(言语障碍、吞咽苦难、震颤等)。本课题目的想证明异体脐带间充质干细胞应用到临床是安全的,并且在治疗遗传性小脑共济失调上是有效的。 

Objectives of Study:

Hereditary cerebellar ataxia is a type of autosomal dominant genetic disease, lesions mainly involving the cerebellum, but the spinal cord and cranial nerves may also be some involvement. Gait ataxia is often the first symptom, then the functional muscle group strength and coordination disorder (speech impairment, swallowing suffering, tremors, etc.). Purpose of this project to prove that allogeneic umbilical cord mesenchymal stem cells are applied to clinical safely, and in the treatment of hereditary cerebellar ataxia is valid. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

1、18-65 岁,性别不限 2、基因诊断为SCA1 

Inclusion criteria

1. 18-65 years of age; 2. Molecularly diagnosed SCA1. 

排除标准:

1、认知障碍 2、精神分裂症患者 3、有严重的肝肾疾病、癫痫、其他中枢神经系统损伤疾病(如脑血管病、帕金森等) 4、年龄《18岁,》65岁 

Exclusion criteria:

1. Cognitively impaired individuals; 2. Schizophrenics; 3. Patients with severe kidney and liver disease, epilepsy, theart disease, pulmonary disease, cardiac arrhythmia, diabetes insipidus, leukemia and some other central neural disease (such as Parkinson disease, accidence of brain vascular et al); 4. Age less than 18 years, age greater than 65 years. 

研究实施时间:

Study execute time:

From2012-01-09To 2012-01-09 

干预措施:

Interventions:

组别:

A

样本量:

10

Group:

A

Sample size:

干预措施:

异体脐带间充质干细胞

干预措施代码:

Intervention:

hereditary cerebellar ataxia

Intervention code:

组别:

B

样本量:

10

Group:

B

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

conventional therapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

海淀 

Country:

China 

Province:

Beijing 

City:

Haidian 

单位(医院):

武警总医院 

单位级别:

三级甲等 

Institution
hospital:

Chinese People's Armed Police General Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

神经功能评价

指标类型:

主要指标 

Outcome:

Nerve functional evaluation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体感诱发电位

指标类型:

次要指标 

Outcome:

somatosensory evoked potential

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脑干听觉诱发电位

指标类型:

次要指标 

Outcome:

brain stem auditory evoked potential

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

urine

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

非随机对照研究

Randomization Procedure (please state who generates the random number sequence and by what method):

non-random study

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2012-01-09
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