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人间充质干细胞治疗新型冠状病毒肺炎(COVID-19)患者肺间质性损害的临床研究
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注册号:

Registration number:

ChiCTR2000031430 

最近更新日期:

Date of Last Refreshed on:

2020-03-31 

注册时间:

Date of Registration:

2020-03-31 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

人间充质干细胞治疗新型冠状病毒肺炎(COVID-19)患者肺间质性损害的临床研究 

Public title:

Clinical study of human umbilical cord mesenchymal stem cells in the treatment of novel coronavirus pneumonia (COVID-19) induced pulmonary fibrosis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

评价人间充质干细胞治疗新型冠状病毒病(COVID-19)患者肺间质性损害的安全性和有效性 

Scientific title:

Evaluation of the safety and efficacy for human umbilical cord mesenchymal stem cells in COVID-19 induced pulmonary fibrosis 

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:

石磊 

研究负责人:

王福生 

Applicant:

Lei Shi 

Study leader:

Fu-Sheng Wang 

申请注册联系人电话:

Applicant telephone:

+86 010-66933333 

研究负责人电话:

Study leader's telephone:

+86 010-66933332 

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:

shilei302@126.com 

研究负责人电子邮件:

Study leader's E-mail:

fswang302@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:

北京市丰台区西四环中路100号 

研究负责人通讯地址:

北京市丰台区西四环中路100号 

Applicant address:

100 West Fourth Ring Road Middle, Fengtai District, Beijing, China 

Study leader's address:

100 West Fourth Ring Road Middle, Fengtai District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100039 

研究负责人邮政编码:

Study leader's postcode:

100039 

申请人所在单位:

中国人民解放军总医院第五医学中心 

Applicant's institution:

The Fifth Medical Center of PLA General 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:

2020-023-D 

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:

中国人民解放军第三〇二医院(解放军总医院第五医学中心)医学伦理委员会 

Name of the ethic committee:

Ethics committee of PLA 302 Military Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-16 

伦理委员会联系人:

丁晋彪 

Contact Name of the ethic committee:

Jinbiao Ding 

伦理委员会联系地址:

北京市丰台区西四环中路100号 

Contact Address of the ethic committee:

100 West Fourth Ring Road Middle, Fengtai District, Beijing, 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:

中国人民解放军总医院第五医学中心 

Primary sponsor:

The Fifth Medical Center of PLA General Hospital 

研究实施负责(组长)单位地址:

北京市丰台区西四环中路100号 

Primary sponsor's address:

100 West Fourth Ring Road Middle, Fengtai District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

The Fifth Medical Center of PLA General Hospital

具体地址:

北京市丰台区西四环中路100号

Institution
hospital:

The Fifth Medical Center of PLA General Hospital

Address:

100 West Fourth Ring Road Middle, Fengtai District

经费或物资来源:

科技部“新型冠状病毒感染的肺炎疫情应急项目” 

Source(s) of funding:

COVID-19 emergency project, Ministry of technology, China 

研究疾病:

新型冠状病毒肺炎(COVID-19) 

Target disease:

Novel Coronavirus Pneumonia (COVID-19) 

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:

II期临床试验 

Study phase:

研究目的:

评价人间充质干细胞治疗新型冠状病毒病(COVID-19)患者肺间质性损害的疗效和安全性 

Objectives of Study:

To evaluate the efficacy and safety of human umbilical cord mesenchymal stem cells in COVID-19 induced pulmonary fibrosis 

药物成份或治疗方案详述:

本研究遵循“药物临床试验质量管理规范(GCP)”原则,开展多中心、前瞻性、开放平行、1:1对照的临床试验。分为治疗组和对照组,分别采取以下治疗措施:(1)治疗组:常规治疗方案+人间充质干细胞(MSC)治疗,4×107/次,静脉注射第0、3、6天,共3次;(2)对照组:常规治疗方案治疗。常规治疗方案参考国家卫生健康委员会修订《新型冠状病毒肺炎诊疗方案(试行第七版)》 

Description for medicine or protocol of treatment in detail:

This study will follow the principles of the "Good Clinical Practice for Drug Control (GCP)" and conduct multicenter, prospective, open, parallel, 1: 1 controlled clinical trials. Patients were divided into treatment group and control group. The following treatment measures are taken: (1) Treatment group: conventional treatment regimen + human umbilical cord mesenchymal stem cells (MSC) treatment, 4 × 10^7/ times, intravenous injection on days 0, 3, and 6 for a total of 3 times; (2) Control group: conventional treatment regimen. The conventional treatment regimen refers to the "Novel Coronavirus Pneumonia Diagnosis and Treatment Protocol (Trial Version 7)" revised by the National Health Commission of the Peoples Republic of China. 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

1) 年龄18~80岁间的男性或女性患者; 2) 愿意签署知情同意书; 3) 符合国家卫健委新型冠状病毒病(COVID-19)诊治方案确诊病例: 4) 高分辨CT提示肺部间质性改变(存在蜂窝影或网格状影) 

Inclusion criteria

1) Male or female patients aged form 18 to 80 years; 2) Willing to sign informed consent; 3) Confirmed cases who meet "Novel Coronavirus Pneumonia Diagnosis and Treatment Protocol" revised by the National Health Commission of the Peoples Republic of China. 4) High-resolution CT indicates interstitial injures in the lungs (honeycomb shadows or grid shadows). 

排除标准:

1)孕妇或哺乳期女性; 2)此次发病前高分辨CT提示存在肺间质性损害 3)其他原因导致的急性肺间质性改变(两周内) 4)有创呼吸机辅助通气 5)多脏器功能衰竭 

Exclusion criteria:

1) Pregnant or lactating women; 2) High-resolution CT before the onset of the disease suggests the presence of interstitial injures in lungs; 3) Acute interstitial lung injures caused by other reasons (within two weeks); 4) Invasive ventilator assisted ventilation; 5) Multiple organ dysfunction syndrome. 

研究实施时间:

Study execute time:

From2020-03-14To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2020-03-20To 2020-12-31 

干预措施:

Interventions:

组别:

治疗组

样本量:

100

Group:

Experimental group

Sample size:

干预措施:

常规治疗方案+MSC治疗

干预措施代码:

Intervention:

Conventional treatment regimen + MSC treatment

Intervention code:

组别:

对照组

样本量:

100

Group:

Control group

Sample size:

干预措施:

常规治疗方案

干预措施代码:

Intervention:

Conventional treatment regimen

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

火神山医院 

单位级别:

 

Institution
hospital:

Huoshenshan Hospital  

Level of the institution:

 

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

湖北妇幼保健院光谷院区 

单位级别:

 

Institution
hospital:

Guanggu District of Hubei Maternal and Child Health Hospital  

Level of the institution:

 

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉金银潭医院 

单位级别:

三甲医院 

Institution
hospital:

Wuhan Jinyintan Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉市中心医院 

单位级别:

三甲医院 

Institution
hospital:

The central hospital of Wuhan  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

心电图

指标类型:

主要指标 

Outcome:

Electrocardiogram

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

圣乔治呼吸评分

指标类型:

主要指标 

Outcome:

St George's Respiratory Questionnaire 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:

胸部高分辨CT影像学改变

指标类型:

主要指标 

Outcome:

High resolution CT for chest

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血气分析

指标类型:

主要指标 

Outcome:

Blood gas analysis

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

经皮血氧饱和度

指标类型:

主要指标 

Outcome:

Percutaneous blood oxygen saturation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

6min步行距离

指标类型:

主要指标 

Outcome:

6 min walking distance

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺功能VCmax

指标类型:

主要指标 

Outcome:

Pulmonary function VCmax

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

主要指标 

Outcome:

Blood routine

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝肾功

指标类型:

主要指标 

Outcome:

Liver and kidney 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:

细胞因子分析

指标类型:

主要指标 

Outcome:

Cytokine analysis

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免疫球蛋白

指标类型:

主要指标 

Outcome:

Immunoglobulin

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

淋巴细胞亚群

指标类型:

主要指标 

Outcome:

Lymphocyte subsets

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

凝血2项

指标类型:

主要指标 

Outcome:

Coagulation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心肌酶谱检测

指标类型:

主要指标 

Outcome:

Myocardial enzymes

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清铁蛋白

指标类型:

主要指标 

Outcome:

Serum ferritin

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

降钙素原

指标类型:

主要指标 

Outcome:

Procalcitonin

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白介素-6

指标类型:

主要指标 

Outcome:

IL-6

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

乳酸

指标类型:

主要指标 

Outcome:

Lactic acid

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

D-二聚体

指标类型:

主要指标 

Outcome:

D-Dimer

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C反应蛋白

指标类型:

主要指标 

Outcome:

CRP

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:

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 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):

本研究为非随机对照研究。

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

This study is a non-randomized controlled study.

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是Yes

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):

2021-6-30 主动公开学术论文或原始数据

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

2022-6-30 article or original data

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:

CRF+EDC

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

CRF+EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-31
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