Today is 2020-10-31

Human umbilcal cord derived mesenchymal stem cells therapy in acute respiratory distress syndrome: a pilot study
download

注册号:

Registration number:

ChiCTR1800014998 

最近更新日期:

Date of Last Refreshed on:

2018-02-27 

注册时间:

Date of Registration:

2018-02-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

人脐带间充质干细胞(hucMSCs)治疗急性呼吸窘迫综合征(ARDS)的探索性研究 

Public title:

Human umbilcal cord derived mesenchymal stem cells therapy in acute respiratory distress syndrome: a pilot study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

人脐带间充质干细胞(hucMSCs)治疗急性呼吸窘迫综合征(ARDS)的探索性研究 

Scientific title:

Human umbilcal cord derived mesenchymal stem cells therapy in acute respiratory distress syndrome: a pilot study 

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:

吕海金 

研究负责人:

吕海金 

Applicant:

Haijin Lv 

Study leader:

Haijin Lv 

申请注册联系人电话:

Applicant telephone:

+86 020 85252673 

研究负责人电话:

Study leader's telephone:

+86 020 85252673 

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:

haijinlv@163.com 

研究负责人电子邮件:

Study leader's E-mail:

haijinlv@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:

广州市天河区天河路600号 

研究负责人通讯地址:

广州市天河区天河路600号 

Applicant address:

600 Tianhe Road, Tianhe District, Guangzhou, Guangdong, China 

Study leader's address:

600 Tianhe Road, Tianhe District, Guangzhou, Guangdong, 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:

中山大学附属第三医院 

Applicant's institution:

The Third Affiliated Hospital, Sun Yat-Sen University 

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:

[2017]38 

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:

中山大学附属第三医院干细胞临床研究伦理委员会 

Name of the ethic committee:

Ethic committee for stem cells clinical trail of the third affiliated hospital of Sun Yat-Sen University 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-11-30 

伦理委员会联系人:

刘畅 

Contact Name of the ethic committee:

Chang Liu 

伦理委员会联系地址:

广州市天河区天河路600号 

Contact Address of the ethic committee:

600 Tianhe Road, Tianhe District, Guangzhou, Guangdong, China 

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:

中山大学附属第三医院 

Primary sponsor:

The Third Affiliated Hospital, Sun Yat-Sen University 

研究实施负责(组长)单位地址:

广州市天河区天河路600号 

Primary sponsor's address:

600 Tianhe Road, Tianhe District, Guangzhou, Guangdong, 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):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

中山大学附属第三医院

具体地址:

广州市天河区天河路600号

Institution
hospital:

The Third Affiliated Hospital, Sun Yat-Sen University

Address:

600 Tianhe Road, Tianhe District, Guangzhou

经费或物资来源:

中山大学附属第三医院临床研究计划 

Source(s) of funding:

The Third Affiliated Hospital of Sun Yat-Sen University,Clinical Research Program 

研究疾病:

急性呼吸窘迫综合征 

Target disease:

acute respiratory distress syndrome 

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:

探索性研究/预试验 

Study phase:

研究目的:

探索人脐带来源的间充质干细胞治疗成人中重度急性呼吸窘迫综合征的安全性 

Objectives of Study:

To investigate safety of human umbilical cord derived mesenchymal stem cells therapy in moderate or severe acute respiratory ditress syndrome in adults 

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.年龄≥18岁 2.同时满足以下条件: (1)有创机械通气伴有中重度ARDS,即OI(PaO2/FiO2)<200;(2)PEEP需求≥8cmH2O;(3)X线胸片呈双肺浸润影;(4)发病1周内;(5)经过肺保护性通气、肺复张、液体保守治疗后无改善的 

Inclusion criteria

1. Aged≥18 years old; 2. Including all the criteria: (1) Invasive ventilation, OI(PaO2/FiO2)<200; (2) PEEP≥8cmH2O; (3) Bilateral inflitration of lung in X-ray or CT; (4) In 1 week after onset; (5) Still OI<200 after protective ventilation or conservative fluid management. 

排除标准:

(1)恶性肿瘤; (2)左心衰肺水肿; (3)X线提示>50%单侧肺不张; (4)妊娠、哺乳期或围产期; (5)既往有严重终末期肺病; (6)APACHEII或SOFA评分预测死亡风险>80%的患者; (7)肝衰竭MELD评分>40分; (8)III或IV级肺动脉高压; (9)未监测或无计划监测有创血压和中心静脉压患者; (10)有深静脉血栓或近3个月有肺栓塞病史; (11)严重脑疝; (12)ARDS发病超过96h 

Exclusion criteria:

(1) Any malignant disease; (2) Cardiogenic pulmonary edema; (3) Over 50% atelectasis either lung lobe in X-ray; (4) Pregnancy or perinatal or lactation; (5) Previous end stage respiratory disease; (6) More than 3 organs failure; (7) Liver failure with MELD score>40; (8) Stage III or IV pulmonary hypertension; (9) None invasive arterial and central venous catheter; (10) Concurrent deep venous thrombus or pulmonary embolism in 3 months; (11) Cerebral hernia; (12) More than 96 hours after ARDS onset. 

研究实施时间:

Study execute time:

From2018-03-01To 2019-12-31 

征募观察对象时间:

Recruiting time:

From2018-03-01To 2019-11-30 

干预措施:

Interventions:

组别:

对照组

样本量:

6

Group:

control group

Sample size:

干预措施:

N.S100ml,静脉滴注

干预措施代码:

Intervention:

normal saline 100ml, ivdrip

Intervention code:

组别:

干细胞组

样本量:

6

Group:

MSC group

Sample size:

干预措施:

hucMSCs 10^6/kg+N.S 100ml,静脉滴注

干预措施代码:

Intervention:

hucMSCs 10^6/kg+N.S 100ml, ivdrip

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

中山大学附属第三医院 

单位级别:

三级甲等 

Institution
hospital:

The Third Affiliated Hospital,Sun Yat-Sen University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

安全性

指标类型:

主要指标 

Outcome:

safety

Type:

Primary indicator 

测量时间点:

输注hucMSCs后24 小时

测量方法:

方案定义的输注相关不良事件(IAEs)

Measure time point of outcome:

24 post-infusion hours

Measure method:

Defined infusion associated events(IAEs) according to protocol

指标中文名:

28天撤机时间

指标类型:

次要指标 

Outcome:

Ventilation free days(VFDs)

Type:

Secondary indicator 

测量时间点:

输注hucMSCs后28天

测量方法:

28天内不需要机械通气的时间总和

Measure time point of outcome:

28 post-infusion days

Measure method:

Summed days without ventilator support

指标中文名:

氧合指数改变

指标类型:

次要指标 

Outcome:

Oxygenation index change

Type:

Secondary indicator 

测量时间点:

输注hucMSCs后7天

测量方法:

动脉血养分压(mmHg)除以吸氧浓度

Measure time point of outcome:

7 post-infusion days

Measure method:

PaO2/FiO2

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

血管内

Sample Name:

Blood

Tissue:

aterial or venous vessels

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:

肺泡灌洗液

组织:

肺部

Sample Name:

bronchoalveolar lavage fluid

Tissue:

lung

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 18 years
最大 Max age 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):

研究者按照试验顺序给12例患者编号,然后采用Resman产生随机数字,再按随机数字升序排列,前6位入组干细胞组,后6位入组对照组。

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

Code each case according to the trail sequence(1,2,3...10,11,12). Use Resman to produce random numbers.Then rank the random numbers, the former 6 correspondent cases will be allocated into MSCs group, the latter 6 correspondent cases will be allocated into control group.

盲法:

非盲法

Blinding:

open label

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):

上传至Resman公共平台www.medresman.org共享

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

sharing IPD in Resman, www.medresman.org

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:

EDC采用Resman公共平台采集管理数据

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

Data collection and management use ResMan,www.medresman.org

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-02-27
return list