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The effects of Umbilical cord blood stem cells in treatment of patients with decompensated HBV-associated live cirrhosis: a randomized controlled trial
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注册号:

Registration number:

ChiCTR-TRC-14004411 

最近更新日期:

Date of Last Refreshed on:

2016-08-25 

注册时间:

Date of Registration:

2014-02-23 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

脐血干细胞治疗乙型肝炎肝硬化失代偿期临床试验 

Public title:

The effects of Umbilical cord blood stem cells in treatment of patients with decompensated HBV-associated live cirrhosis: a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

脐血干细胞治疗乙型肝炎肝硬化失代偿期临床试验 

Scientific title:

The effects of Umbilical cord blood stem cells in treatment of patients with decompensated HBV-associated live cirrhosis: a randomized controlled trial 

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:

孟忠吉 

研究负责人:

孟忠吉 

Applicant:

Zhongji Meng 

Study leader:

Zhongji Meng 

申请注册联系人电话:

Applicant telephone:

+86 071 98801821 

研究负责人电话:

Study leader's telephone:

+86 071 98801821 

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:

zhongji.meng@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhongji.meng@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:

32 South Renmin Road, Shiyan Hubei, China 

Study leader's address:

32 South Renmin Road, Shiyan Hubei, China 

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:

湖北医药学院附属太和医院 

Applicant's institution:

Taihe Hospital, Hubei University of Medicine 

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:

002 

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研究伦理委员会 

Name of the ethic committee:

Ethics Committee of Taihe Hospital, Hubei University of Medicine 

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:

湖北医药学院附属太和医院 

Primary sponsor:

Taihe Hospital, Hubei University of Medicine 

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:

32 South Renmin Road, Shiyan Hubei, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖北

市(区县):

Country:

China

Province:

Hubei

City:

单位(医院):

湖北省科技厅

具体地址:

湖北省科技厅

Institution
hospital:

Science and technology department of Hubei Province

Address:

Science and technology department of Hubei Province

经费或物资来源:

湖北省科技厅 

Source(s) of funding:

Science and technology department of Hubei Province 

研究疾病:

肝硬化 

Target disease:

Liver cirrhosis 

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:

N/A 

研究目的:

建立脐血干细胞移植治疗乙型肝炎肝硬化失代偿期的临床规范化标准,为终末期肝病提供新的治疗方案;确定细胞生物治疗终末期肝病的临床有效率、安全性等技术指标,提高生存质量、延长生存期 

Objectives of Study:

To establish a standard protocol for the use of Umbilical cord blood stem cells in the treatment of patients with decompensated HBV-associated live cirrhosis, and to evaluate the clinical effects and safety of Umbilical cord blood stem cells in patients with end-stage liver diseases 

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:

①乙型肝炎病史; ②确诊为乙型肝炎肝硬化; ③HBV DNA PCR定量>5x102 拷贝/ml(相当于100 IU/ ml); ④Child评分异常,筛选时大于等于7。 

Inclusion criteria

1. A history of chronic HBV infection; 2. Ultrasonographic evidence of LC; 3. HBV DNA >100 IU/ ml; 4. CTP Score more than 7. 

排除标准:

① 肝细胞癌和其它脏器肿瘤; ② 有证据提示为重型肝炎:TBil超过正常值上限的10 倍;PTA<40%; ③ 2月内有消化道出血史; ④ 严重并发症; ⑤ 合并其他HAV、HCV、HDV、HEV、HIV等病毒感染者; ⑥ 肝外胆管疾病; ⑦ 超声提示肝、门静脉和脾静脉血栓; ⑧ 酗酒或吸毒; ⑨ 既往(半年内)有核苷(酸)类抗乙肝病毒治疗史者; ⑩ 不签署知情同意书。 

Exclusion criteria:

1. The presence of HCC and any underlying neoplasm; 2. Liver failure (TBil>10 ULN, PTA<40%); 3. A history of variceal bleeding 2 months prior to the enrolment; 4. The presence of severe comorbidities; 5. Coinfection with HAV, HCV, HDV, HEV, HIV, etc; 6. Evidence of extrahepatic biliary diseases; 7. The presence of hepatic, portal, or splenic vein thromboses on Doppler ultrasonography; 8. Active substance abuse; 9. A history of nucleot(s)ides administration 6 months prior to the enrolment; 10. Unwillingness to sign the informed consent form. 

研究实施时间:

Study execute time:

From2011-01-01To 2015-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

30

Group:

Treatment group

Sample size:

干预措施:

脐血干细胞

干预措施代码:

Intervention:

Umbilical cord blood stem cells

Intervention code:

组别:

对照组

样本量:

30

Group:

Control group

Sample size:

干预措施:

含1%人血白蛋白的生理盐水

干预措施代码:

Intervention:

0.9% Sodium chloride containing 1% Human Albumin

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北省 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

湖北医药学院附属太和医院 

单位级别:

三级甲等医院 

Institution
hospital:

Taihe Hospital, Hubei University of Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

肝功能

指标类型:

主要指标 

Outcome:

Liver function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝硬度

指标类型:

主要指标 

Outcome:

liver stiffnes

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

乙肝病毒载量

指标类型:

次要指标 

Outcome:

HBV DNA

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:

肝脏

Sample Name:

Blood

Tissue:

Liver

人体标本去向

使用后销毁 

说明

na

Fate of sample:

Destruction after use 

Note:

NA

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):

统计学教研室职员采用随机数字表

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

By staff in the department of statistics using table of random number

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):

湖北医药学院附属太和医院

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

Taihe Hospital, Hubei University of Medicine

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:

湖北医药学院附属太和医院

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

Taihe Hospital, Hubei University of Medicine

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-02-23
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