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人自然杀伤细胞联合间充质干细胞治疗重症新型冠状病毒肺炎(COVID-19)的临床研究
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注册号:

Registration number:

ChiCTR2000030944 

最近更新日期:

Date of Last Refreshed on:

2020-03-19 

注册时间:

Date of Registration:

2020-03-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

人自然杀伤细胞联合间充质干细胞治疗重症新型冠状病毒肺炎(COVID-19)的临床研究 

Public title:

Clinical study of human NK cells and MSCs transplantation for severe novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

人自然杀伤细胞联合间充质干细胞治疗重症新型冠状病毒肺炎的开放、多中心与对照的探索性临床研究 

Scientific title:

An open, multi-center, control, exploratory clinical study of human NK cells and UC-MSCs transplantation for severe novel coronavirus pneumonia 

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:

段中鑫 

研究负责人:

叶小群 

Applicant:

Duan Zhongxin 

Study leader:

Ye Xiaoqun 

申请注册联系人电话:

Applicant telephone:

+86 0791 86668667 

研究负责人电话:

Study leader's telephone:

+86 0791 86300047 

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:

duanzhongxin1986@163.com 

研究负责人电子邮件:

Study leader's E-mail:

511201663@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:

南昌市高新区艾溪湖北路688号 

研究负责人通讯地址:

南昌市东湖区民德路1号 

Applicant address:

688 North Aixihu Road, High-tech Zone, Nanchang, Jiangxi, China 

Study leader's address:

1 Minde Road, Donghu District, Nanchang, Jiangxi, China 

申请注册联系人邮政编码:

Applicant postcode:

330096 

研究负责人邮政编码:

Study leader's postcode:

330006 

申请人所在单位:

江西美奥生物技术有限公司 

Applicant's institution:

Jiangxi Mayo Biotechnologies Co.LTD 

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)医研伦审第(01)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:

南昌大学第二附属医院医学研究伦理委员会 

Name of the ethic committee:

Medical research ethics committee of the Second Affiliated Hospital of Nanchang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-06 

伦理委员会联系人:

易云 

Contact Name of the ethic committee:

Yi Yun 

伦理委员会联系地址:

南昌市东湖区民德路1号 

Contact Address of the ethic committee:

1 Minde Road, Donghu District, Nanchang Jiangxi, 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:

南昌大学第二附属医院 

Primary sponsor:

The Second Affiliated Hospital of Nanchang University 

研究实施负责(组长)单位地址:

南昌市东湖区民德路1号 

Primary sponsor's address:

1 Minde Road, Donghu District, Nanchang, Jiangxi, 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):

江西

市(区县):

南昌

Country:

China

Province:

Jiangxi

City:

Nanchang

单位(医院):

南昌大学第二附属医院

具体地址:

南昌市东湖区民德路1号

Institution
hospital:

The Second Affiliated Hospital of Nanchang University

Address:

1 Minde Road, Donghu District

国家:

中国

省(直辖市):

江西

市(区县):

南昌

Country:

China

Province:

Jiangxi

City:

Nanchang

单位(医院):

江西美奥生物技术有限公司

具体地址:

南昌市高新区艾溪湖北路688号

Institution
hospital:

Jiangxi Mayo Biotechnologies Co.LTD

Address:

688 North Aixihu Road, High-Tech Zone

国家:

中国

省(直辖市):

江西

市(区县):

南昌

Country:

China

Province:

Jiangxi

City:

Nanchang

单位(医院):

江西省胸科医院

具体地址:

南昌市东湖区叠山路346号

Institution
hospital:

Jiangxi Chest Hospital

Address:

346 Dieshan Road, Donghu District, Nanchang

经费或物资来源:

江西省与南昌市科技部门资助及单位自筹 

Source(s) of funding:

Funded by the Science and Technology departments of Jiangxi Province and Nanchang City, Self-raised funds 

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:

I期临床试验 

Study phase:

研究目的:

本研究为开放、多中心与对照设计的多次给药剂量探索,人体安全性、耐受性和疗效评估临床试验。所有患者不改变原有sNCP治疗方案,仅在原有方案基础上加NK和MSCs。初步评价人脐血自然杀伤细胞联合脐带来源间充质干细胞辅助治疗重症2019-nCoV所致sNCP的安全性和有效性。 

Objectives of Study:

This study is an open, multicenter and controlled clinical trial designed for multiple dose which will be explored human safety, tolerance and efficacy evaluation. All patients did not change the original SNCP treatment plan, only added NK and MSCs on the basis of the original plan. To evaluate the safety and efficacy of natural killer cells combined with cord derived mesenchymal stem cells in the treatment of severe 2019-ncov-induced sNCP. 

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:

如果患者在首次ICU入院后5-7天内符合以下所有标准,则有资格入选。 患者符合2019-nCoV肺炎诊断标准(新型冠状病毒感染的肺炎诊疗方案(试行第五版),国卫办医函〔2020〕103号) 原发病为2019-nCoV感染 呼吸窘迫,RP≥30次/份 静息状态下,指氧饱合度≤93% 动脉血氧分压(PaO2)/吸氧浓度(FiO2)≤300nnHg (1mmHg=0.133kPa) 影像学资料提示为双侧病变 自愿参加临床研究,理解并签署知情同意书 

Inclusion criteria

1. Patients are eligible for inclusion if they meet all of the following criteria within 5-7 days after the first admission to the ICU. 2. The patients met the diagnostic criteria of 2019-nCoV pneumonia (new coronavirus infection) pneumonia treatment plan (Fifth version), the National Health Office [2020] No.103.; 3. The primary disease is 2019 nCoV infection; 4. Respiratory distress, RP >=30 times/unit; 5. Under resting state, blood oxygen saturation <=93%; 6. PaO2 / FiO2 <=300nnhg (1mmhg = 0.133kpa); 7. Imaging data suggest bilateral lesions 8. Volunteer to participate in clinical research, understand and sign informed consent. 

排除标准:

其他非病毒感染所致(如创伤)所致sNCP WHO分级 III or IV肺动脉高压 肺及其他系统恶性肿瘤患者 哺乳期女性或筛选期女性血妊娠检测阳性者 特发性IgA缺乏症者 近期内(3个月)发生心脑血管事件者 肺移植患者 HIV阳性患者 根据研究者的判断,排除患有可能混淆研究结果、干扰受试者参与研究程序或不符合受试者参加研究最佳利益的任何疾病、治疗或实验室异常的病史或当前证据的受试者。 

Exclusion criteria:

1. sNCP caused by other non-viral infections (such as trauma); 2. WHO grade III or IV pulmonary hypertension; 3. Malignant tumor in lung and other systems; 4. Lactating women or screening women with positive blood pregnancy test; 5. Idiopathic IgA deficiency; 6. Recent cardiovascular and cerebrovascular events (3 months); 7. Lung transplanted patients; 8. HIV positive patients; 9. According to the researcher's judgment, these subjects will be excluded because of some causes, such as any disease, treatment, or laboratory abnormal history or current evidence, which may confound the results of the study, interfere with the subject's participation in the study procedure, or be not in the best interest of the subject's participation in the study. 

研究实施时间:

Study execute time:

From2020-03-01To 2020-08-31 

征募观察对象时间:

Recruiting time:

From2020-09-01To 2021-02-28 

干预措施:

Interventions:

组别:

A组

样本量:

10

Group:

Experimental group

Sample size:

干预措施:

sNCP现行临床治疗基础上,增加NK细胞和MSC静脉回输

干预措施代码:

Intervention:

On the basis of the current clinical treatment of SNCP, NK cells and MSCs were increased

Intervention code:

组别:

对照组

样本量:

10

Group:

Control group

Sample size:

干预措施:

现行临床治疗基础

干预措施代码:

Intervention:

current clinical treatment of SNCP

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江西 

市(区县):

南昌 

Country:

China 

Province:

Jiangxi 

City:

Nanchang 

单位(医院):

南昌大学第二附属医院 

单位级别:

三甲医院 

Institution
hospital:

The Second Affiliated Hospital of Nanchang University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

江西 

市(区县):

南昌 

Country:

China 

Province:

Jiangxi 

City:

Nanchang 

单位(医院):

江西省胸科医院 

单位级别:

三甲医院 

Institution
hospital:

Jiangxi Chest Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

血清炎症因子变化

指标类型:

主要指标 

Outcome:

Changes of serum inflammatory factors

Type:

Primary indicator 

测量时间点:

细胞移植前、细胞移植开始后第1、2、3、5和8个月

测量方法:

酶联免疫吸附测定

Measure time point of outcome:

Measure method:

ELISA

指标中文名:

患者死亡风险

指标类型:

主要指标 

Outcome:

Patient death risk

Type:

Primary indicator 

测量时间点:

sNCP患者接受NK与MSCs输注后的6个月内

测量方法:

临床密切观察

Measure time point of outcome:

Measure method:

指标中文名:

用药相关不良反应和不良事件

指标类型:

主要指标 

Outcome:

Drug related adverse reactions and events

Type:

Primary indicator 

测量时间点:

干细胞移植治疗前、干细胞移植开始后第7天、1、2、3和6个月

测量方法:

血常规、肝肾功能生化、过敏观察、X线胸片和酶联免疫吸附测定ELISA等检测

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

静脉血

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 4 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):

按照受试者入组的时间顺序,依照事先制定好的随机分配表随机进入到一个分组中

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

Randomly enter a group according to the time sequence of subjects' entering the group and the pre-determined random assignment table

盲法:

Open label

Blinding:

Open label

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):

2021.3.3 通过邮件

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

2021.3.31 by email

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:

通过病例记录表采集记录数据

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

Collect record data through case record table and establish electronic database management data.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-18
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