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Effective and safety evaluation of human umbilical cord derived mesenchymal stem cells (hU-MSCs)in systemic lupus erythematosus
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注册号:

Registration number:

ChiCTR-OPC-15006322 

最近更新日期:

Date of Last Refreshed on:

2015-04-30 

注册时间:

Date of Registration:

2015-04-28 

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(hU-MSCs)移植治疗系统性红斑狼疮的有效性及安全性评价研究 

Public title:

Effective and safety evaluation of human umbilical cord derived mesenchymal stem cells (hU-MSCs)in systemic lupus erythematosus 

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(hU-MSCs)移植治疗系统性红斑狼疮的有效性及安全性评价研究 

Scientific title:

Effective and safety evaluation of human umbilical cord derived mesenchymal stem cells (hU-MSCs)in systemic lupus erythematosus 

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:

杨奕 

研究负责人:

徐祥 

Applicant:

Yi Yang 

Study leader:

Xiang Xu 

申请注册联系人电话:

Applicant telephone:

+86 18502389013 

研究负责人电话:

Study leader's telephone:

+86 13637843870 

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:

yangyilyx@163.com 

研究负责人电子邮件:

Study leader's E-mail:

xiangxu@ymail.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:

第三军医大学大坪医院风湿免疫科 

研究负责人通讯地址:

第三军医大学大坪医院野战外科研究所 

Applicant address:

Department of Rheumatology and Immunology,Daping Hospital, Third Military Medical University, Chongqing 

Study leader's address:

Research Institute of Surgery, Daping Hospital, Third Military Medical University, Chongqing 

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:

第三军医大学大坪医院风湿免疫科 

Applicant's institution:

Department of Rheumatology and Immunology,Daping Hospital, Third Military Medical University, Chongqing 

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:

医研伦审(2015)第007号 

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:

第三军医大学第三附属医院伦理委员会 

Name of the ethic committee:

The Ethics Committee of The Third Affiliated Hospital of The Third Military Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-03-06 

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:

第三军医大学大坪医院野战外科研究所 

Primary sponsor:

Research Institute of Surgery, Daping Hospital, Third Military Medical University, Chongqing 

研究实施负责(组长)单位地址:

重庆市渝中区长江支路10号 

Primary sponsor's address:

10 Changjiang Road, Yuzhong 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(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

第三军医大学大坪医院

具体地址:

重庆市渝中区长江支路10号

Institution
hospital:

Daping Hospital, The Third Military Medical University

Address:

10 Changjiang Road, Yuzhong district, Chongqing, China

经费或物资来源:

自筹 

Source(s) of funding:

self-financed 

研究疾病:

系统性红斑狼疮 

Target disease:

systemic lupus erythematosus 

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:

I期临床试验 

Study phase:

I (Phase I study) 

研究目的:

探讨干细胞治疗系统性红斑狼疮的新策略。 

Objectives of Study:

To discuss a new strategy of stem cells to treat systemic lupus erythematosus. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续病例 

Study design:

Case series 

纳入标准:

1.签署知情同意书者,患者及家属依从性好 ; 2.年龄在18-65岁的系统性红斑狼疮病人 ; 3.所有患者均符合2012年SLICC的SLE分类标准(见附件一),且SLEDAI≥8 , or BILAG score A/B; 4.狼疮性肾炎24h尿蛋白≥1g; 5. 难治性LN定义为以下治疗方案失败: 5.1维持期糖皮质激素疗法(口服泼尼松超过7.5mg/d); 5.2环磷酰胺疗法(0.4 ~ 0.6 / m2每2周,持续6个月),或者其他免疫抑制剂如麦考酚吗乙酯(MMF)2g/天,持续3个月; 

Inclusion criteria

1. Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital; 2. Patients of SLE, to be aged 18 years to 65 years old; 3. All patients fulfilled the 2012 SLICC of SLE classification criteria, SLEDAI >=8;or BILAG score A/B; 4. Lupus nephritis with 24h urine protein>=1g; 5. Refractory disease as determined by failure of the following regimens: 5.1 Trial of corticosteroids (oral prednisone more than 7.5 mg/day); 5.2 Trial of cyclophosphamide 0.4~0.6 / m2 every two weeks for six months, or other immunosuppressive drugs, such as MMF 2 g/day, for three months. 

排除标准:

1.患者由于存在无法纠正的疾病,比如晚期肿瘤或者其它晚期疾病; 2.患者处于可预知的垂死状态; 3.既往有骨髓,肺脏,肝脏,胰腺或小肠移植病史; 4.已知或潜在的门脉高压,慢性黄疸,慢性肝硬化,腹水; 5.严重的心脏和肺衰竭,或其他重要器官的严重的不可逆损害或衰竭; 6.无法控制的感染; 7.在本试验开始前30天内参加了其他临床试验的志愿者; 8.怀孕或哺乳期妇女; 9.患者既往存在对生物制品过敏史,超敏反应或者其它严重反应; 10.HIV病毒感染。 

Exclusion criteria:

1. Patients with uncorrected disease, such as advanced cancer or other terminal illness, the prospective survival period less than 28 days; 2. Patients in the foreseeable dying state; 3. Have the bone marrow, lungs, liver, pancreas, or small bowel transplantation history; 4. Known or potential of portal hypertension, chronic icteric, chronic liver cirrhosis and ascites; 5.Have severe heart and lung failure, or irreversible damage or failure of other major organs; 6. Uncontrolled infection; 7. Patient participating or having participated in a clinical trial with another investigational drug Within 30 days before the start of this clinical trial; 8. Patient is pregnant or nursing; 9. History of patient is allergic to biological products; 10. HIV infected; 

研究实施时间:

Study execute time:

From2015-05-01To 2017-12-01 

干预措施:

Interventions:

组别:

试验组

样本量:

35

Group:

treatment group

Sample size:

干预措施:

人脐带间充质干细胞(hU-MSCs)

干预措施代码:

Intervention:

human umbilical cord derived mesenchymal stem cells (hU - MSCs)

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(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

第三军医大学大坪医院 

单位级别:

三甲 

Institution
hospital:

Daping Hospital, The Third Military Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

系统性红斑狼疮疾病活动指数评分

指标类型:

主要指标 

Outcome:

SLEDAI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

大不列颠群岛狼疮评估组指数

指标类型:

主要指标 

Outcome:

BILAG

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

狼疮血清学

指标类型:

次要指标 

Outcome:

Lupus serology

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肾功能

指标类型:

次要指标 

Outcome:

Renal function

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝功能

指标类型:

次要指标 

Outcome:

Liver function

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:

Routine 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:

肌电图

指标类型:

次要指标 

Outcome:

Electromyography

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

影像学

指标类型:

次要指标 

Outcome:

Imaging

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:

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 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):

无随机

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

Non-randomized

盲法:

Blinding:

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:

Real time access

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):

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

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:

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-04-28
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