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人脐带间充质干细胞输注治疗糖尿病足溃疡的临床研究
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注册号:

Registration number:

ChiCTR2200055885 

最近更新日期:

Date of Last Refreshed on:

2022-08-29 

注册时间:

Date of Registration:

2022-01-22 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

人脐带间充质干细胞输注治疗糖尿病足溃疡的临床研究 

Public title:

Topical and intravenous administration of human umbilical cord mesenchymal stem cell in patients with diabetic foot ulcer: A pilot 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输注治疗糖尿病足溃疡的安全性及有效性研究 

Scientific title:

The safety and efficacy of human umbilical cord mesenchymal stem cell administration in patients with diabetic foot ulcer 

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:

张澈 

研究负责人:

张澈 

Applicant:

Zhang Che 

Study leader:

Zhang Che 

申请注册联系人电话:

Applicant telephone:

+86 719 8801691 

研究负责人电话:

Study leader's telephone:

+86 719 8801691 

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:

prof.zh@163.com 

研究负责人电子邮件:

Study leader's E-mail:

prof.zh@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:

湖北省十堰市人民南路32号 

研究负责人通讯地址:

湖北省十堰市人民南路32号 

Applicant address:

32 Renmin Road South, Shiyan, Hubei, China  

Study leader's address:

32 Renmin Road South, Shiyan, Hubei, China  

申请注册联系人邮政编码:

Applicant postcode:

422000 

研究负责人邮政编码:

Study leader's postcode:

422000 

申请人所在单位:

十堰市太和医院 

Applicant's institution:

Affiliated Taihe Hospital of Hubei University of Medicine 

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:

20090903 

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:

十堰市太和医院医学伦理委员会 

Name of the ethic committee:

The Institutional Review Board of the Affiliated Taihe Hospital of Hubei University of Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2011-03-25 

伦理委员会联系人:

陈霞平 

Contact Name of the ethic committee:

Chen Xiaping 

伦理委员会联系地址:

湖北省十堰市人民南路32号 

Contact Address of the ethic committee:

32 Renmin Road South, Shiyan, 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:

十堰市太和医院 

Primary sponsor:

Affiliated Taihe Hospital of Hubei University of Medicine 

研究实施负责(组长)单位地址:

湖北省十堰市人民南路32号 

Primary sponsor's address:

32 Renmin Road South, Shiyan, 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):

十堰

Country:

China

Province:

Hubei

City:

Shiyan

单位(医院):

十堰市太和医院

具体地址:

人民南路32号

Institution
hospital:

Affiliated Taihe Hospital of Hubei University of Medicine

Address:

32 Renmin Road South

经费或物资来源:

西安交通大学临床研究基金(XJTU1AF-CRF-2016-023) 

Source(s) of funding:

The Grant for Clinical Research in Xi’an Jiaotong University (grant numbers XJTU1AF-CRF-2016-023) 

研究疾病:

糖尿病足溃疡 

Target disease:

diabetic foot ulcer 

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:

探索性研究/预试验 

Study phase:

研究目的:

探讨经局部及静脉输注hUC-MSC治疗DFU的安全性以及有效性。 

Objectives of Study:

To evaluate the safety and theraputic efficacy of hUC-MSC transfusion in diabetic patients with diabetic foot ulcers. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1.根据1999年WHO推荐的糖尿病诊断标准诊断为2型糖尿病; 2.年龄18~80岁,性别不限; 3.DFU的Wagner分级达1~4级; 4.DFU创面形成时间超过6周,经常规内科治疗无效。 

Inclusion criteria

1.Diagnosed with type 2 diabetes according to the World Health Organization (WHO) guideline; 2.Aged 18 to 80 years; 3.Wagner grade >= 1; 4.Lower-limb unhealing ulcer after 6 weeks of routine treatments. 

排除标准:

1.已知对干细胞或干细胞衍生产物或干细胞制剂中的成分过敏; 2.合并严重的心、肝、肺等器官功能障碍; 3.存在未被控制的严重自身免疫性疾病或严重的细菌、真菌或病毒全身感染性疾病; 4.有恶性肿瘤现病史及既往史。 

Exclusion criteria:

1.Known allergy to stem cell or its derivant product or vehicle; 2.Serious cardiovascular, pulmonary, or liver dysfunction; 3.Uncontrolled immunological disease or active serious systemic infection; 4.Malignancy history.  

研究实施时间:

Study execute time:

From2009-09-15To 2020-09-15 

征募观察对象时间:

Recruiting time:

From2009-09-15To 2018-09-15 

干预措施:

Interventions:

组别:

hUC-MSC治疗组

样本量:

15

Group:

hUC-MSC treatment group

Sample size:

干预措施:

hUC-MSC输注+对症支持治疗

干预措施代码:

Intervention:

hUC-MSC infusion+supporting treatment

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):

十堰 

Country:

China 

Province:

Hubei 

City:

Shiyan 

单位(医院):

十堰市太和医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Taihe Hospital of Hubei University of Medicine  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

Wagner评分

指标类型:

主要指标 

Outcome:

Wagner grade

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

DFU创面愈合率

指标类型:

主要指标 

Outcome:

DFU healing rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

DFU复发率

指标类型:

次要指标 

Outcome:

DFU recurrence rate

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 39 years
最大 Max age 76 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):

不适用(非随机)

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

Not applicable

盲法:

不适用

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否No

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):

由于病人隐私及伦理制约,本研究原始数据不可共享,但在必要情况下可通过主要研究者获取。

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

The data are not publicly available due to privacy or ethical restrictions, which are available on request from the corresponding author upon reasonable request.

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:

1.研究者将数据真实、准确、完整、及时地载入研究病历。 2.所有AE均应记录在研究病历中,SAE在规定时间内作出报告并记录在案。 3.根据研究病历的项目建立本研究专用的数据库系统。 4.对数据进行查对,对不一致的结果值逐项核对原始记录,予以更正。

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

1.Data should be inputted into medical chart timely and exactly. 2.AE should be recorded in the medical chart, while SAE should be reported to authority within 24h after awareness. 3.Study specific database should be set up. 4.Data verification and correction should be conducted termly.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-01-22
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