Today is 2018-06-23

Clinical research on subacute ischemic stroke therapy by umbilical cord blood stem cell
download

注册号:

Registration number:

ChiCTR-TRC-14005071 

最近更新日期:

Date of Last Refreshed on:

2014-12-13 

注册时间:

Date of Registration:

2014-07-23 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

脐血干细胞治疗亚急性期缺血性脑卒中临床研究 

Public title:

Clinical research on subacute ischemic stroke therapy by umbilical cord blood stem cell 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

脐血干细胞治疗亚急性期缺血性脑卒中临床研究 

Scientific title:

Clinical research on subacute ischemic stroke therapy by umbilical cord blood stem cell 

研究课题代号(代码):

Study subject ID:

GYS0043 

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:

王云甫 

研究负责人:

王云甫 

Applicant:

Yunfu Wang 

Study leader:

Yunfu Wang 

申请注册联系人电话:

Applicant telephone:

+86 13971920566 

研究负责人电话:

Study leader's telephone:

+86 13971920566 

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:

wyfymc@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wyfymc@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:

湖北省十堰市人民南路32号 

研究负责人通讯地址:

湖北省十堰市人民南路32号 

Applicant address:

Neurology department of Taihe Hospital, No. 32, South Renmin Road, Shiyan, Hubei Province 

Study leader's address:

Neurology department of Taihe Hospital, No. 32, South Renmin Road, Shiyan, Hubei Province 

申请注册联系人邮政编码:

Applicant postcode:

442000 

研究负责人邮政编码:

Study leader's postcode:

442000 

申请人所在单位:

湖北省十堰市太和医院 

Applicant's institution:

Taihe Hospital of Shiyan, Hubei Province 

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:

001 

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:

十堰市太和医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Shiyan Taihe Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-01-20 

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:

湖北省十堰市太和医院 

Primary sponsor:

Taihe Hospital of Shiyan, Hubei Province 

研究实施负责(组长)单位地址:

湖北省十堰市人民南路32号 

Primary sponsor's address:

No. 32, South Renmin Road, Shiyan, Hubei Province 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

湖北省公益性科技研究项目资金 

Source(s) of funding:

funds of science and technology research project, Hubei Province 

研究疾病:

缺血性脑血管病 

Target disease:

Ischemic cerebrovascular disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

建立脐血干细胞移植治疗亚急性期缺血性脑卒中的临床规范化标准,为缺血性脑卒中提供新的治疗方案;确定细胞生物治疗缺血性脑卒中的临床有效率、安全性等技术指标,提高生存质量。 

Objectives of Study:

Establish the clinical standard of umbilical cord blood stem cell transplantation in the treatment of subacute ischemic stroke, to provide a new treatment for ischemic stroke; and determine the clinical efficiency, safety and other technical indicators of cell biological for ischemic stroke, to improve the quality of survival. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

年龄在18~75岁,性别不限;受试者为脑梗死,发病时间为2周并经MRI证实为基底节区缺血性脑血管病,NIHSS评分4-12分;无严重心肝肾以及出凝血功能障碍;受试者自愿或其法定监护人依照受试者的意愿签署知情同意书。 

Inclusion criteria

Among the age of 18~75 years old, gender not limited; Participants with cerebral infarction, the basal ganglia ischemic cerebrovascular disease onset time in two weeks and confirmed by MRI, NIHSS score of 4-12 points; Without serious heart, liver, kidney and the blood coagulation dysfunction; The informed consent signed by voluntary participants or their legal guardian subjects in accordance with the participants' willingness. 

排除标准:

有严重的药物过敏病史或过敏体质者; 有较严重的心血管、肝脏、肾脏疾病; 有较严重的呼吸、内分泌系统疾病; 严重的血液系统疾病; 有已知或可疑恶性肿瘤发生; 有难以控制的感染; 有较严重的脑损伤,造成神经功能缺陷严重者或精神科疾病患者;血清HIV抗体阳性、梅毒抗体阳性;有酗酒和药物滥用者;妊娠或有妊娠可能及哺乳期的女性;医生认为还存在有其他原因不能纳入干细胞治疗者。 

Exclusion criteria:

Have a history of serious drug allergy or allergic constitution; Have a serious cardiovascular, liver, kidney disease; With more severe respiratory, endocrine system diseases; With serious blood system diseases; With known or suspected malignant tumor; With difficult to control the infection; With a severe brain injury, resulting in severe neurological defects or psychiatric disease; Serum HIV antibody, syphilis antibody positive; Alcoholism and drug abusers; Pregnancy or may pregnancy and lactation women; Doctors think there are other reasons can not be included in the stem cell therapy. 

研究实施时间:

Study execute time:

From2014-08-01To 2015-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

30

Group:

Experience group

Sample size:

干预措施:

干细胞

干预措施代码:

Intervention:

Stem cells

Intervention code:

组别:

对照

样本量:

30

Group:

Control

Sample size:

干预措施:

在内科药物治疗的基础上采用安慰剂对照

干预措施代码:

Intervention:

Placebo + basal treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

NIHSS

指标类型:

主要指标 

Outcome:

NIHSS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ADL

指标类型:

主要指标 

Outcome:

ADL

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

MRI

指标类型:

主要指标 

Outcome:

MRI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

MRS

指标类型:

主要指标 

Outcome:

MRS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

MRA

指标类型:

主要指标 

Outcome:

MRA

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

3D-ALS of brain

指标类型:

主要指标 

Outcome:

3D-ALS of brain

Type:

Primary 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:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 75 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

由计算机控制人员产生随机数字后分为2组

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

Generating random number by the computer control of personnel divided into 2 groups

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:

 2014-07-23
返回列表