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Clinical trials of mesenchymal stem cells for the treatment of pneumonitis caused by novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000029990 

最近更新日期:

Date of Last Refreshed on:

2020-02-18 

注册时间:

Date of Registration:

2020-02-18 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

人间充质干细胞治疗 新型冠状病毒感染肺炎(COVID-19)的临床研究 

Public title:

Clinical trials of mesenchymal stem cells for the treatment of pneumonitis caused by novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

人间充质干细胞治疗 新型冠状病毒感染肺炎(COVID-19)的临床研究 

Scientific title:

Clinical trials of mesenchymal stem cells for the treatment of pneumonitis caused by novel coronavirus (COVID-19) 

研究课题代号(代码):

Study subject ID:

2016YFA0101000 

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:

赵春华 

研究负责人:

赵春华/金荣华 

Applicant:

Robert Chunhua Zhao 

Study leader:

Robert Chunhua Zhao/Ronghua Jin 

申请注册联系人电话:

Applicant telephone:

+86 010-65125311 

研究负责人电话:

Study leader's telephone:

+86 010-65125311 

申请注册联系人传真 :

Applicant Fax:

+86 010-65125311 

研究负责人传真:

Study leader's fax:

+86 010-65125311 

申请注册联系人电子邮件:

Applicant E-mail:

zhaochunhua@vip.163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhaochunhua@vip.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:

东城区东单3条5号微循环楼6层 

研究负责人通讯地址:

东城区东单3条5号微循环楼6层 

Applicant address:

5 Shantiao Street, Dongdan, Dongcheng District, Beijing, China 

Study leader's address:

5 Shantiao Street, Dongdan, Dongcheng District, Beijing, 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:

中国医学科学院基础医学研究所 

Applicant's institution:

institute of basic medicine, Chinese Academy of medical sciences 

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:

京佑科伦字[2020]007号 

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:

Ethical Committee of Beijing You-An Hospital 

Name of the ethic committee:

北京佑安医院伦理委员会 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-02 

伦理委员会联系人:

北京佑安医院伦理委员会 

Contact Name of the ethic committee:

Ethical Committee of Beijing You-An Hospital 

伦理委员会联系地址:

北京市丰台区右安门外西头条8号 

Contact Address of the ethic committee:

8 Toutiao Street West, You-An-Men, 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:

中国医学科学院基础医学研究所 

Primary sponsor:

Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences 

研究实施负责(组长)单位地址:

东城区东单3条5号微循环楼6层 

Primary sponsor's address:

5 Shantiao Street, Dongdan, Dongcheng 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):

北京佑安医院

具体地址:

北京市丰台区右安门外西头条8号

Institution
hospital:

Beijing You-An Hospital

Address:

8 Toutiao Street West, You-An-Men, Fengtai District

经费或物资来源:

国家重点研发计划 

Source(s) of funding:

The National Key Research and Development Program of China (2016YFA0101000) 

研究疾病:

新型冠状病毒感染肺炎 

Target disease:

pneumonitis caused by novel coronavirus  

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:

I期+II期 

Study phase:

1-2 

研究目的:

本研究目的是评价人间充质干细胞治疗新型冠状病毒(2019-nCoV)肺炎的安全性和有效性。 

Objectives of Study:

The purpose of this study was to evaluate the safety and efficacy of human mesenchymal stem cells in the treatment of new coronavirus (2019-nCoV) pneumonia. 

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. 男性或女性,18岁-70岁 2. 2019新型冠状病毒核酸检测阳性; 3. 诊断为2019新型冠状病毒肺炎的中到重普通型病例,即符合下列临床表现: 具有发热、呼吸道症状,影像学可见肺炎表现; 4. 诊断为2019新型冠状病毒肺炎的重型病例,即符合下列任何一条: (1)呼吸频率增快(≥30 次/分),呼吸困难,口唇紫绀; (2)静息状态下,指氧饱和度≤93%;或血氧下降迅速; (3)动脉血氧分压(PaO2)/吸氧浓度(FiO2)≤300mmHg(1mmHg=0.133kPa); 5. 本人或委托代理人签署知情同意书。 6. 同意收集临床样本 

Inclusion criteria

1. Male or female, 18-95 years old; 2. 2019 new coronavirus nucleic acid test positive; 3. Diagnosed as moderate to severe cases of new coronavirus pneumonia in 2019, which meets the following clinical manifestations: 4. With fever and respiratory symptoms, imaging shows pneumonia; 5. A severe case diagnosed with 2019 new coronavirus pneumonia, that is, any of the following: (1) Increased breathing rate (>=30 beats / min), difficulty breathing, cyanosis of lips; (2) In the resting state, it means that oxygen saturation <=93%; or blood oxygen drops rapidly; (3) Arterial blood oxygen partial pressure (PaO2) / oxygen concentration (FiO2) <=300mmHg (1mmHg = 0.133kPa); 6. I or the authorized agent signed the informed consent form; 7. Agree to collect clinical samples. 

排除标准:

1. 过去五年内有恶性疾病; 2. 临床预判无生存希望,仅进行临终关怀的病例,或者深度昏迷且在入院三小时内对支持治疗措施无反应的病例。 3. 正在参加其他临床试验或者3个月内参加过其他临床试验的受试者。 4. 极重度休克以及呼吸衰竭的病例。 

Exclusion criteria:

1. Malignant disease in the past five years; 2. The clinical prediction is that there is no hope for survival, only cases of hospice care, or cases of deep coma that do not respond to supportive treatment measures within three hours of admission; 3. Subjects who are participating in other clinical trials or within 3 months; 4. Cases of very severe shock and respiratory failure. 

研究实施时间:

Study execute time:

From2020-01-30To 2020-03-31 

征募观察对象时间:

Recruiting time:

From2020-01-30To 2020-03-31 

干预措施:

Interventions:

组别:

实验组

样本量:

60

Group:

experimental group

Sample size:

干预措施:

间充质干细胞

干预措施代码:

Intervention:

mesenchymal stem cells

Intervention code:

组别:

对照组

样本量:

60

Group:

control group

Sample size:

干预措施:

生理盐水

干预措施代码:

Intervention:

saline

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京佑安医院 

单位级别:

三甲 

Institution
hospital:

beijing youan houspital  

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):

武汉普仁医院 

单位级别:

三甲 

Institution
hospital:

Wuhan PuRen Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海光华中西医结合医院 

单位级别:

三甲 

Institution
hospital:

Shanghai Guanghua integrated traditional Chinese and Western Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

呼吸系统功能改善(血氧饱和度)恢复时间

指标类型:

主要指标 

Outcome:

Improved respiratory system function (blood oxygen saturation) recovery time

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 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):

单广良,统计软件:SAS 9.4 完全随机分组方法 随机分为A组为安慰剂组,B组为干细胞治疗组 可以按病人入组顺序给予受试者编号,然后按照组别给予安慰剂或干细胞治疗。

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

GUANGLIANG SHAN Completely random grouping Randomly divided into group A as placebo group and group B as stem cell treatment group Subjects can be numbered in the order in which the patients are enrolled, followed by placebo or stem cell therapy.

盲法:

未说明

Blinding:

Not stated

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):

相关网站和文章

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

Related websites and articles

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:

将由接受过培训的工作人员采集所有数据。然后将数据填写在设计的病例报告表(CRF)中,定期由项目组成员录入电子数据库中。研究者负责确保录入采集数据的完整、准确与及时记录。然后由项目组对病历中的数据进行审查。按照适用的标准和数据清理程序进行临床数据管理,以确保数据的完整性。

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

All data will be collected by staff trained. The data is then filled in a designed case report form (CRF), which is regularly entered by the project team members into an electronic database . The investigator is responsible for ensuring that the data entered is complete, accurate, and timely. The project team then reviews the data in the medical records. Manage clinical data in accordance with applicable standards and data cleaning procedures to ensure data integrity.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-18
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