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人脐带间充质干细胞移植治疗难治性狼疮性肾炎的初步临床研究
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注册号:

Registration number:

ChiCTR-OPN-17011139 

最近更新日期:

Date of Last Refreshed on:

2017-04-13 

注册时间:

Date of Registration:

2017-04-13 

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移植治疗难治性狼疮性肾炎的初步临床研究 

Public title:

Human umbilical cord mesenchymal stem cell transplantation in refractory lupus nephritis: a clinical 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移植治疗难治性狼疮性肾炎的初步临床研究 

Scientific title:

Human umbilical cord mesenchymal stem cell transplantation in refractory lupus nephritis: a clinical 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:

张湖海 

研究负责人:

赵洪雯 

Applicant:

Zhang Huhai 

Study leader:

Zhao Hongwen 

申请注册联系人电话:

Applicant telephone:

+86 13677696006 

研究负责人电话:

Study leader's telephone:

+86 13983360655 

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:

184215827@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

358984844@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:

中国重庆市沙坪坝区高滩岩正街30号 

研究负责人通讯地址:

中国重庆市沙坪坝区高滩岩正街30号 

Applicant address:

30 Gaotanyan Main Street, Shapingba District, Chongqing, China 

Study leader's address:

30 Gaotanyan Main Street, Shapingba District, Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

400038 

研究负责人邮政编码:

Study leader's postcode:

400038 

申请人所在单位:

第三军医大学第一附属医院肾科 

Applicant's institution:

Department of Nephrology; the First Affiliated Hospital of the Third Military Medical 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:

2016科研第35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:

第三军医大学第一附属医院伦理委员会 

Name of the ethic committee:

The Ethics Committee of Third Military Medical University's First Affiliated Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

第三军医大学第一附属医院肾科 

Primary sponsor:

Department of Nephrology; The First Affiliated Hospital of the Third Military Medical University 

研究实施负责(组长)单位地址:

中国重庆市沙坪坝区高滩岩正街30号 

Primary sponsor's address:

30 Gaotanyan Main Street, Shapingba District, Chongqing, 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):

重庆市

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

第三军医大学第一附属医院

具体地址:

中国重庆市沙坪坝区高滩岩正街30号

Institution
hospital:

The First Affiliated Hospital of the Third Military Medical University

Address:

30 Gaotanyan Road, Shapingba District, Chongqing

经费或物资来源:

第三军医大学第一附属医院 

Source(s) of funding:

The First Affiliated Hospital of the Third Military Medical University 

研究疾病:

狼疮性肾炎 

Target disease:

Lupus Nephritis 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

预试验 

Study phase:

Pilot study 

研究目的:

探讨人脐带间充质干细胞移植治疗难治性狼疮性肾炎的有效性及其安全性如何,为临床治疗难治性狼疮性肾炎探索新的治疗方式 

Objectives of Study:

To evaluate the efficacy and safety of the umbilical cord mesenchymal stem cell transplantation and explore a novel therapy in the treatment of refractory lupus nephritis 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

(1)年龄在18-60岁(包括18周岁和60周岁)性别不限 (2)符合美国风湿病协会(1982)修订的SLE诊断标准 (3)狼疮性肾炎Ⅲ、Ⅳ-S、IV-G、Ⅴ或Ⅲ+Ⅴ、Ⅳ+Ⅴ型 (4)临床确诊为难治性狼疮性肾炎(治疗24周蛋白尿仍大于1g/d或较 治疗前下降小于25%,并排除可逆性因素;SLEDAI评分>8分) 

Inclusion criteria

(1) Aged 18-60 years old male and female; (2) Meet the Emendatory SLE diagnostic criteria of The American rheumatism association (1982); (3) Patient with pathologically confirmed Lupus nephritis III-IV-SIV-GV or III+VIV+ V type; (4) The Clinical diagnosis of refractory with lupus nephritis is confirmed (Proteinuria > 1 g/d After 24 weeks of treatment or down less than 25%, compared with before treatment and exclusion of reversible factors; The SLEDAI score > 8). 

排除标准:

(1)合并其他自身免疫性疾病、结缔组织疾病、淀粉样变 (2)肺动脉压≥50 mmHg (3)有任何更复杂的医疗问题,可能干扰研究行为或导致风险增加,如恶性肿瘤、糖尿病、血液疾病、心脏疾病、肝脏疾病、艾滋病、病毒性肝炎,其它获得性、先天性免疫缺陷疾病,或有器官移植史等 (4)对任何培养细胞成分过敏 (5)临床上有活动性感染 (6)无法理解研究的潜在风险和收益,无法按要求随访评估 (7)无民事行为能力 (8)药物或酒精滥用的历史 (9)妊娠或哺乳期妇女 (10)研究者认为不合适参加临床试验者 

Exclusion criteria:

(1) With other autoimmune diseases, connective tissue diseases, amyloidosis; (2) The pulmonary artery pressure 50 mmHg or higher; (3) Any more complicated medical problems may interfere with the action or result in increased risk, such as malignant tumor, diabetes, blood disease, heart disease, liver disease, AIDS, viral hepatitis and other acquired and congenital immunodeficiency disease, or has a history of organ transplantation, etc; (4) Allergic to any culture cell component; (5) Clinically active infection; (6) Couldn't understand the potential risks and benefits of research, unable to follow-up assessment as required; (7) No capacity for civil conduct; (8) The history of drug or alcohol abuse; (9) Pregnancy or lactation; (10) Researchers think not appropriate for clinical subjects. 

研究实施时间:

Study execute time:

From2016-06-30To 2019-09-30 

干预措施:

Interventions:

组别:

治疗组

样本量:

11

Group:

Treat group

Sample size:

干预措施:

脐带间充质干细胞输注

干预措施代码:

Intervention:

umbilical cord mesenchymal stem cell transplantation

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆市 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

第三军医大学第一附属医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital of the Third Military Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

24小时蛋白尿

指标类型:

主要指标 

Outcome:

24-hours proteinuria

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

复发率

指标类型:

次要指标 

Outcome:

recurrence rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

缓解率

指标类型:

次要指标 

Outcome:

remission rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

死亡率

指标类型:

次要指标 

Outcome:

mortality

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

补体C3

指标类型:

次要指标 

Outcome:

complement C3

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

双链DNA

指标类型:

次要指标 

Outcome:

dsDNA

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Sm抗体

指标类型:

次要指标 

Outcome:

Sm antibody

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血肌酐

指标类型:

次要指标 

Outcome:

Serum creatine

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清白蛋白

指标类型:

主要指标 

Outcome:

Serum albumin

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

估算肾小球滤过率

指标类型:

次要指标 

Outcome:

eGFR-EPI

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SLEDAI score

指标类型:

次要指标 

Outcome:

SLEDAI 评分

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:

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 60 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):

N/A.

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

N/A.

盲法:

Blinding:

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

N/A.

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

N/A.

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:

N/A.

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

N/A.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-04-13
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