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Comparative analysis of curative effect of autologous bone marrow mesenchymal stem cell transplantation and autologous mononuclear bone marrow cells treating cerebral paralysis
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注册号:

Registration number:

ChiCTR-TRC-12002568 

最近更新日期:

Date of Last Refreshed on:

2015-10-29 

注册时间:

Date of Registration:

2012-10-10 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

自体骨髓间充质干细胞移植与自体骨髓单个核细胞移植治疗脑性瘫的疗效对比分析 

Public title:

Comparative analysis of curative effect of autologous bone marrow mesenchymal stem cell transplantation and autologous mononuclear bone marrow cells treating cerebral paralysis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

自体骨髓间充质干细胞移植与自体骨髓单个核细胞移植治疗脑性瘫的疗效对比分析 

Scientific title:

Comparative analysis of curative effect of autologous bone marrow mesenchymal stem cell transplantation and autologous mononuclear bone marrow cells treating cerebral paralysis 

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:

刘学彬 

研究负责人:

安沂华 

Applicant:

Xuebin Liu 

Study leader:

Yihua An 

申请注册联系人电话:

Applicant telephone:

+86 10 57976849 

研究负责人电话:

Study leader's telephone:

+86 10 57976849 

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:

liuxb912@163.com 

研究负责人电子邮件:

Study leader's E-mail:

riveran@163.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 中国人民武装警察部队总医院 

研究负责人通讯地址:

北京市海淀区永定路69号 中国人民武装警察部队总医院 

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:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

中国人民武装警察部队总医院 

Applicant's institution:

General Hospital of Chinese People's Armed Police Forces 

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:

03152010 

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 Forces 

伦理委员会批准日期:

Date of approved by ethic committee:

2010-04-02 

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 Forces 

研究实施负责(组长)单位地址:

北京市海淀区永定路69号 中国人民武装警察部队总医院 

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:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

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 Forces

Address:

69 Yongding Road, Haidian District, Beijing

经费或物资来源:

自持经费 

Source(s) of funding:

self-support 

研究疾病:

脑瘫 

Target disease:

Cerebral palsy 

研究疾病代码:

G80.901 

Target disease code:

G80.901 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

I期+II期 

Study phase:

1-2 

研究目的:

对比分析骨髓间充质干细胞移植与骨髓单个核细胞移植治疗脑性瘫的疗效以及影响因素 

Objectives of Study:

To compare the curative effect of autologous bone marrow mesenchymal stem cell transplantation and autologous mononuclear bone marrow cells of cerebral paralysis, and factors affecting the efficacy. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

明确诊断的脑性瘫,MRI提示脑白质发育不良 

Inclusion criteria

Diagnosis of cerebral palsy, MRI white matter hypoplasia tips 

排除标准:

颅内感染,严重呼吸循环系统疾病,恶性血液病、实体瘤病史者。 

Exclusion criteria:

Intracranial infection, severe respiratory and circulatory system diseases, hematologic malignancies, solid tumors, a history. 

研究实施时间:

Study execute time:

From2010-05-01To 2012-12-31 

干预措施:

Interventions:

组别:

A组

样本量:

20

Group:

A

Sample size:

干预措施:

自体骨髓间充质干细胞移植

干预措施代码:

Intervention:

autologous bone marrow mesenchymal transplantation

Intervention code:

组别:

B组

样本量:

20

Group:

B

Sample size:

干预措施:

自体骨髓单个核细胞移植

干预措施代码:

Intervention:

autologous mononuclear bone marrow cells

Intervention code:

组别:

C组

样本量:

20

Group:

C

Sample size:

干预措施:

康复锻炼

干预措施代码:

Intervention:

Rehabilitation 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):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民武装警察部队总医院 

单位级别:

三级甲等医院 

Institution
hospital:

General Hospital of Chinese People's Armed Police Forces  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

GMFM评分

指标类型:

主要指标 

Outcome:

GMFM Score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

T淋巴细胞亚群检测

指标类型:

次要指标 

Outcome:

T lymphocyte subsets determination

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:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 4 years
最大 Max age 10 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):

随机分配三组编号,SPSS程序设置随机种子。

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

Three groups Number will be dandomly assigned.Random number sequence will come from random seed by s

盲法:

三盲法: 康复评估人员 手术实施者 手术患者

Blinding:

Triple-blind trial: Rehabilitation evaluators Surgery implementers Surgical patients

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):

中国人民武装警察部队总医院 细胞移植科

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

Deaprtment of Cell Transplantation, General Hospital of Chinese people's Armed Police Forces

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:

中国人民武装警察部队总医院 细胞移植科

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

Deaprtment of Cell Transplantation, General Hospital of Chinese people's Armed Police Forces

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2012-10-10
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