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异体人牙髓间充质干细胞治疗新型冠状病毒肺炎(COVID-19)重症肺炎的安全性和有效性研究
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注册号:

Registration number:

ChiCTR2000031319 

最近更新日期:

Date of Last Refreshed on:

2020-03-27 

注册时间:

Date of Registration:

2020-03-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

异体人牙髓间充质干细胞治疗新型冠状病毒肺炎(COVID-19)重症肺炎的安全性和有效性研究 

Public title:

Safety and Efficacy Study of Allogeneic Human Dental Pulp Mesenchymal Stem Cells to Treat Severe novel coronavirus pneumonia (COVID-19) patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

关于异体人牙髓间充质干细胞治疗COVID-19重症肺炎的安全性和有效性的单中心、前瞻性、随机对照临床试验 

Scientific title:

Safety and Efficacy Study of Allogeneic Human Dental Pulp Mesenchymal Stem Cells to Treat Severe Pneumonia of COVID-19:a Single-center, Prospective, Randomised Clinical 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:

叶青松 

研究负责人:

叶青松,周晨亮 

Applicant:

Prof Qingsong Ye 

Study leader:

Prof. Qingsong Ye; Dr. Chenliang Zhou 

申请注册联系人电话:

Applicant telephone:

+86 027-88041911 

研究负责人电话:

Study leader's telephone:

+86 027 88041919-83920 

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:

qingsongye@foxmail.com 

研究负责人电子邮件:

Study leader's E-mail:

20215851@qq.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:

武汉市武昌区解放路238号武汉大学人民医院再生医学中心 

研究负责人通讯地址:

武汉市武昌区解放路238号武汉大学人民医院科研处 

Applicant address:

238 Jiefang Road, Wuchang District, Wuhan, Hubei, China 

Study leader's address:

238 Jiefang Road, Wuchang District, Wuhan, Hubei, China 

申请注册联系人邮政编码:

Applicant postcode:

430060 

研究负责人邮政编码:

Study leader's postcode:

430060 

申请人所在单位:

武汉大学人民医院再生医学中心 

Applicant's institution:

Center for Regenerative Medicine, Renmin Hospital of Wuhan 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:

WDRY2020-K106 

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:

武汉大学人民医院临床研究伦理委员会 

Name of the ethic committee:

Committee of Ethics for Clinical Research, Renmin Hospital of Wuhan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-14 

伦理委员会联系人:

陈红 

Contact Name of the ethic committee:

Hong Chen 

伦理委员会联系地址:

武汉市武昌区解放路238号武汉大学人民医院科研处 

Contact Address of the ethic committee:

Research Office, Renmin Hospital of Wuhan University, 238 Jiefang Road, Wuchang District, Wuhan, Hubei, 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:

武汉大学人民医院 

Primary sponsor:

Renmin Hospital of Wuhan University 

研究实施负责(组长)单位地址:

湖北省武汉市武昌区解放路238号 

Primary sponsor's address:

238 Jiefang Road, Wuchang District, Wuhan, 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):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉大学人民医院

具体地址:

湖北省武汉市武昌区解放路238号

Institution
hospital:

Renmin Hospital of Wuhan University

Address:

238 Jiefang Road, Wuchang District

经费或物资来源:

北京吴祖泽科技发展基金会 

Source(s) of funding:

Zuze Wu Foundation for Science & Technology Development 

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:

其它 

Study phase:

N/A 

研究目的:

评价应用人牙髓间充质干细胞治疗新型冠状病毒所致重症肺炎的安全性和有效性;为探索应用人牙髓间充质干细胞治疗新型冠状病毒所致重症肺炎,降低死亡率,改善临床预后提供新的治疗方案。 

Objectives of Study:

To evaluate the safety and efficacy of allogeneic human dental pulp mesenchymal stem cells in the treatment of severe pneumonia caused by COVID-19; To explore the effects of human dental pulp mesenchymal stem cells in the treatment of severe pneumonia of COVID-19 in terms of reducing mortality and improving clinical prognosis; To discover a new therapeutic strategy for COVID-19 using allogeneic human dental pulp mesenchymal stem cells. 

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 18-65周岁,性别不限; (2)自愿参加本临床研究并提供《知情同意书》; (3)诊断为重型新冠肺炎:呼吸窘迫,RR30次/分;静息状态下,指氧饱和度93%;动脉血氧分压/吸氧浓度300mmHg;新冠病毒核酸检测为阳性。 (4)胸部影像检查证实肺脏受累。 

Inclusion criteria

(1) Aged 18-65 years; (2) Voluntarily participate in this clinical trial and sign off "informed consent form"; (3) Diagnosed with severe pneumonia of COVID: respiratory distress, RR >30 times / min; resting oxygen saturation of 93% or less; arterial partial pressure of oxygen / oxygen concentration 300mmHg; SARS-CoV-2 nucleic acid test was positive. (4) Chest imaging confirm COVID-19 featured changes in lung. 

排除标准:

(1)在筛选评估之前的30天内接受任何针对CoVID-2019的临床试验药物治疗者; (2)严重肝病(例如Child Pugh分数≥C或AST>上限的5倍); (3)已知严重肾功能不全者(估计肾小球滤过率≤30mL/min/1.73 m2)或接受连续性肾脏替代治疗,血液透析,腹膜透析的患者; (4)HIV,乙肝,结核,流感病毒,腺病毒和其他呼吸道感染病毒的共同感染; (5)研究筛选前一个月之内没有保护措施的性生活的女性患者; (6)妊娠、哺乳期妇女或应用雌性激素避孕的女性; (7)本人或配偶计划在研究期间和研究结束后 6个月内妊娠的患者; (8)研究者认为其他不适宜参加的情况。 

Exclusion criteria:

(1) Receive any clinical trial drug treatment for COVID-2019 within 30 days before the screening assessment; (2) Severe liver disease (e.g., Child Pugh score >=C or AST> 5 times of the upper limit); (3) Patients with known severe renal insufficiency (estimated glomerular filtration rate <=30mL / min/1.73 m2) or patients receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis; (4) Co-infection of HIV, hepatitis B, tuberculosis, influenza virus, adenovirus or other respiratory infection viruses; (5) Female patients who have no sexual protection in the last 30 days prior to the screening assessment; (6) Pregnant or lactating women or women using estrogen contraception; (7) Patients who are planning to become pregnant during the study period or within 6 months after the end of the study period; (8) Other conditions that the researchers consider inappropriate for participating in this clinical trial. 

研究实施时间:

Study execute time:

From2020-04-01To 2020-07-31 

征募观察对象时间:

Recruiting time:

From2020-04-01To 2020-04-30 

干预措施:

Interventions:

组别:

牙髓干细胞治疗组

样本量:

10

Group:

hDPSCs group

Sample size:

干预措施:

常规治疗+静脉注射牙髓间充质干细胞

干预措施代码:

Intervention:

Routine treatment + Intravenous injection of human dental pulp stem cells

Intervention code:

组别:

对照组

样本量:

10

Group:

Control group

Sample size:

干预措施:

常规治疗+静脉注射生理盐水

干预措施代码:

Intervention:

Routine treatment + Placebo

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):

武汉大学人民医院 

单位级别:

三甲医院 

Institution
hospital:

Renmin Hospital of Wuhan University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

临床改善时间

指标类型:

主要指标 

Outcome:

TTCI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免疫指标

指标类型:

次要指标 

Outcome:

Immune biomarkers

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺部CT表现

指标类型:

次要指标 

Outcome:

Degree of Lung Lesion by CT

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病毒核酸转阴时间

指标类型:

次要指标 

Outcome:

Time of SARS-CoV-2 test turns negative

Type:

Secondary 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:

次要指标 

Outcome:

Blood test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

氧饱和度

指标类型:

次要指标 

Outcome:

SPO2

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸频率

指标类型:

次要指标 

Outcome:

RR

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体温

指标类型:

次要指标 

Outcome:

Body temperature

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生化检查

指标类型:

次要指标 

Outcome:

Biochemical tests

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:

Sample Name:

blood

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:

粪便

组织:

Sample Name:

feces

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:

尿液

组织:

Sample Name:

urine

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:

尚未开始

Not yet recruiting

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):

简单随机化(随机数字表)

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

Simple randomization (table of random numbers)

盲法:

未说明

Blinding:

Not stated

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):

试验完成后6个月内通过网络平台

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

Internet platform, within six month after the completion of the trial

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:

数据采集使用病例记录表,数据管理使用电子采集和管理系统

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

Data acquisition using Case Record Form (CRF),and data management using electronic collection and management system

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-27
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