Today is 2018-12-14

Clincal study of umbilical cord-derived mesenchymal stem cells in the graft-versus-host disease after allogeneic hematopoietic stem cell transplantation
download

注册号:

Registration number:

ChiCTR-ONC-17011480 

最近更新日期:

Date of Last Refreshed on:

2017-05-24 

注册时间:

Date of Registration:

2017-05-24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

人脐带血来源的间充质干细胞治疗异基因造血干细胞移植后移植物抗宿主病的临床研究 

Public title:

Clincal study of umbilical cord-derived mesenchymal stem cells in the graft-versus-host disease after allogeneic hematopoietic stem cell transplantation 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

人脐带血来源的间充质干细胞治疗异基因造血干细胞移植后移植物抗宿主病的临床研究 

Scientific title:

Clincal study of umbilical cord-derived mesenchymal stem cells in the graft-versus-host disease after allogeneic hematopoietic stem cell transplantation 

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:

肖霞 

研究负责人:

赵明峰 

Applicant:

Xiao Xia 

Study leader:

Zhao Mingfeng 

申请注册联系人电话:

Applicant telephone:

+86 13652056797 

研究负责人电话:

Study leader's telephone:

+86 13752640369 

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:

xxiiaao@126.com 

研究负责人电子邮件:

Study leader's E-mail:

mingfengzhao@sina.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:

天津市南开区复康路24号 

研究负责人通讯地址:

天津市南开区复康路24号 

Applicant address:

24 Fukang Road, Nankai District, Tianjin, China 

Study leader's address:

24 Fukang Road, Nankai District, Tianjin, 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:

天津市第一中心医院 

Applicant's institution:

Tianjin First Central Hospital 

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:

2017N038KY 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

天津市第一中心医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Tianjin First Central Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

2017-04-25 

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:

天津市第一中心医院 

Primary sponsor:

Tianjin First Central Hospital 

研究实施负责(组长)单位地址:

天津市南开区复康路24号 

Primary sponsor's address:

24 Fukang Road, Nankai District, Tianjin, 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):

天津市

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津市第一中心医院

具体地址:

天津市南开区复康路24号

Institution
hospital:

Tianjin First Central Hospital

Address:

24 Fukang Road, Nankai District, Tianjin, China

经费或物资来源:

天津市卫生局/第一中心医院 

Source(s) of funding:

Tianjin Health Bureau/ Tianjin First Cental Hospital 

研究疾病:

移植物抗宿主病 

Target disease:

graft-versus-host disease  

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

评价人脐带来源间充质干细胞治疗异基因造血干细胞移植后移植物抗宿主病的有效性 

Objectives of Study:

To evaluate the efficacy of umbilical cord-derived mesenchymal stem cells in the graft-versus-host disease after allogeneic hematopoietic stem cell transpantation  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续病例 

Study design:

Case series 

纳入标准:

1.异基因造血干细胞移植后发生移植物抗宿主病的患者;2.年龄14-65岁;3.KPS评分>60分;4.无严重脏器功能损害; 5.估计生存期>1个月  

Inclusion criteria

1. Allo-HSCT patients occured GVHD; 2. Aged between 14 to 65 years; 3. KPS score > 60; 4. No serious organ dysfunction; 5. Expected survival > 1 months. 

排除标准:

1.有严重脏器功能损害; 2.合并其他恶性肿瘤需要治疗; 3.存在脑功能紊乱的临床症状或严重的精神性疾病不能理解或遵从研究方案; 4.不能如期随访者; 5.无法完成治疗计划和随访观察的患者 

Exclusion criteria:

1. Have serious organ dysfunction; 2. Combined with other cancer need treatment; 3. Presence of clinical signs of brain dysfuntion or severe mental illness can not comply with the study protocol; 4. Can not scheduled follow-up; 5. Can not guarantee the completion of the treatment plan and the necessary follow-up observation.  

研究实施时间:

Study execute time:

From2017-06-01To 2019-05-31 

干预措施:

Interventions:

组别:

间充质干细胞输注组

样本量:

30

Group:

MSCs infusion group

Sample size:

干预措施:

输注四-六次人脐带来源间充质干细胞(1*10^6/kg,每周1次,共4次)

干预措施代码:

Intervention:

infusion umbilical cord-derived MSCs 1*10^6/kg per one week, total 4-6 times

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

天津市 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津市第一中心医院 

单位级别:

三甲医院 

Institution
hospital:

Tianjin First Central Hospital  

Level of the institution:

Tertiary A hospital  

测量指标:

Outcomes:

指标中文名:

移植物抗宿主病

指标类型:

主要指标 

Outcome:

GVHD

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总生存

指标类型:

次要指标 

Outcome:

overall survival

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

无复发生存

指标类型:

次要指标 

Outcome:

Relapse-free survival

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全性

指标类型:

副作用指标 

Outcome:

Secuity

Type:

Adverse events 

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:

骨髓

组织:

Sample Name:

Bone marrow

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:

外周血

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 14 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):

连续病例

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

case series

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:

Within six months after the trial complete

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):

试验完成后6个月内公开,采用临床试验公共管理平台ResMan向公众开放查询

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

The data will be published in the public management platform of clinical trials ResMan after the Study Completed 6 months

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:

病史、治疗过程以及监测结果记录于病历中,于天津市第一中心医院病案室保存;每一个病例均有CRF表格,于研究者处保存。

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

History, treatment process and monitoring results recorded in the medical records, in Tianjin First Central Hospital record room. CRF form for every case saved by the researchers

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-05-24
return list