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自体纯化CD34+细胞与外周血单个核细胞移植治疗难治性重度肢体缺血的临床研究
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注册号:

Registration number:

ChiCTR1800019401 

最近更新日期:

Date of Last Refreshed on:

2018-11-09 

注册时间:

Date of Registration:

2018-11-09 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

自体纯化CD34+细胞与外周血单个核细胞移植治疗难治性重度肢体缺血的临床研究 

Public title:

A clinical study for purified CD34+ cell and peripheral blood-derived mononuclear cell auto-transplantation in treating no-option critical limb ischemia  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

自体纯化CD34+细胞与外周血单个核细胞移植治疗难治性重度肢体缺血的临床研究 

Scientific title:

A clinical study for purified CD34+ cell and peripheral blood-derived mononuclear cell auto-transplantation in treating no-option critical limb ischemia 

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:

潘天岳 

研究负责人:

符伟国 

Applicant:

Tianyue Pan 

Study leader:

Weiguo Fu 

申请注册联系人电话:

Applicant telephone:

+86 21 15800802319 

研究负责人电话:

Study leader's telephone:

+86 64041990 

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:

tianyuepan@126.com 

研究负责人电子邮件:

Study leader's E-mail:

fu.weiguo@zs-hospital.sh.cn 

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:

中国上海市枫林路180号 

研究负责人通讯地址:

中国上海市枫林路180号 

Applicant address:

180 Fenglin Road, Shanghai, China 

Study leader's address:

180 Fenglin Road, Shanghai, China 

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:

复旦大学附属中山医院 

Applicant's institution:

Zhongshan Hospital, Fudan 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:

No.2009-016 

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:

复旦大学附属中山医院生物医学研究伦理委员会 

Name of the ethic committee:

Biomedical Research Ethics Committee of Zhongshan Hospital, Fudan University, Shanghai, China 

伦理委员会批准日期:

Date of approved by ethic committee:

2009-03-05 

伦理委员会联系人:

杨梦婕 

Contact Name of the ethic committee:

Mengjie Yang 

伦理委员会联系地址:

中国上海市枫林路180号 

Contact Address of the ethic committee:

180 Fenglin Road, Shanghai, 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:

复旦大学附属中山医院 

Primary sponsor:

Zhongshan Hospital, Fudan University 

研究实施负责(组长)单位地址:

中国上海市枫林路180号 

Primary sponsor's address:

180 Fenglin Road, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

复旦大学附属中山医院

具体地址:

中国上海市枫林路180号

Institution
hospital:

Zhongshan Hospital, Fudan University, Shanghai, China

Address:

180 Fenglin Road, Shanghai, China

经费或物资来源:

复旦大学血管外科研究所经费支持 

Source(s) of funding:

Fund of Institute of vascular surgery, Fudan University, Shanghai, China 

研究疾病:

外周血管疾病/重度肢体缺血 

Target disease:

Peripheral artery disease/critical limb ischemia 

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:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

研究纯化CD34+细胞与外周血单个核细胞移植治疗难治性重度肢体缺血的安全性和有效性,评估有效者的预后因素,指导选择患者的标准 

Objectives of Study:

To confirm the safety and efficacy of purified CD34+ cell and peripheral blood-derived mononuclear cell auto-transplantation in treating no-option critical limb ischemia, to evaluate the prognostic factors of responders, and guide the criteria of patient selection 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1、男性或女性,年龄介于18至80岁之间 2、因血管狭窄闭塞性病变导致的下肢缺血 3、静息痛或不超过跖骨平面的组织缺损,卢瑟福4-5级 4、解剖学上不适合手术或腔内介入治疗,或者经手术或腔内介入后3个月内仍无疗效 5、经药物治疗至少1月后静息痛仍无法缓解,或伤口不缩小 6、有完整的基线信息和移植后6个月内的生存、截肢、伤口愈合和静息痛缓解情况 7、已签署知情同意书 

Inclusion criteria

1) male or female aged between 18 and 80 years; 2) diagnosis of limb ischemia due to vascular stenosis or vascular occlusion; 3) rest pain or tissue loss under the superior level of metatarsus (Rutherford class4 or5); 4) being anatomically unsuitable for surgery or an endovascular intervention or showing no improvement for at least 3 months following surgery or an endovascular intervention; 5) if present, unrelieved rest pain or a woundsize that was not reduced after at least 1 month of medical treatment; 6) complete baseline data and known status of survival, amputation, wound healing and rest pain relief at 6 months after transplantation; 7)A consent form been signed. 

排除标准:

1、入院前三个月内有严重的健康相关事件,包括但不限于心肌梗死、脑卒中、肺栓塞、严重的肝肾功能障碍 2、患有恶性肿瘤 

Exclusion criteria:

1) serious health events <3 months before admission, including but not limited to a myocardial infarction, cerebral apoplexy, a pulmonary embolism, severe hepatic and renal dysfunction; 2) a diagnosis of malignancy at baseline. 

研究实施时间:

Study execute time:

From2009-04-01To 2018-06-01 

干预措施:

Interventions:

组别:

纯化CD34+细胞组

样本量:

52

Group:

Group 1

Sample size:

干预措施:

纯化CD34+细胞肌肉注射移植

干预措施代码:

Intervention:

Intramuscular transplantation of purified CD34+ cells

Intervention code:

组别:

非纯化外周血单个核细胞组

样本量:

51

Group:

Group 2

Sample size:

干预措施:

非纯化外周血单个核细胞肌肉注射移植

干预措施代码:

Intervention:

Intramuscular transplantation of peripheral blood mononuclear cell

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

复旦大学附属中山医院 

单位级别:

3级甲等 

Institution
hospital:

Zhongshan Hospital, Fudan University, Shanghai, China  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

踝上截肢

指标类型:

主要指标 

Outcome:

Major amputation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

无踝上截肢生存率

指标类型:

主要指标 

Outcome:

Major amputation-free survival

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

重度肢体缺血完全缓解

指标类型:

主要指标 

Outcome:

Complete remission of critical limb ischemia

Type:

Primary indicator 

测量时间点:

术后6月内

测量方法:

Measure time point of outcome:

Six months post-transplantation

Measure method:

指标中文名:

伤口愈合情况

指标类型:

次要指标 

Outcome:

Wound healing

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Six months post-transplantation

Measure method:

指标中文名:

Wong-Baker疼痛评分

指标类型:

次要指标 

Outcome:

Wong-Baker pain scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

踝肱指数

指标类型:

次要指标 

Outcome:

Ankle-brachial index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

经皮氧分压

指标类型:

次要指标 

Outcome:

Transcutaneous oxygen pressure

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:

外周血

组织:

外周血

Sample Name:

peripheral blood

Tissue:

peripheral blood

人体标本去向

使用后销毁 

说明

使用后销毁

Fate of sample:

Destruction after use 

Note:

Destruciton after use

标本中文名:

外周血单个核细胞

组织:

外周血

Sample Name:

peripheral blood mononuclear cells

Tissue:

peripheral blood

人体标本去向

使用后保存 

说明

长期冻存

Fate of sample:

Preservation after use 

Note:

long term cryopreserved

标本中文名:

纯化的CD34+细胞

组织:

外周血

Sample Name:

purified CD34+ cells

Tissue:

peripheral blood

人体标本去向

使用后保存 

说明

长期冻存

Fate of sample:

Preservation after use 

Note:

long term cryopreserved

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 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):

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

None

盲法:

N/A

Blinding:

N/A

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):

通过邮箱联系研究负责人,且采用临床试验公共管理平台ResMan向公众开放查询

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

Contact by E-mail of study leader,and the data will be published in the public management platform of clinical trials ResMan

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:

使用CRF记录病史、治疗过程以及监测结果 使用EXCEL对数据进行电子化管理

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

Using Case Record Form to record History, treatment process and monitoring results. Using Excel to elctronically manage the data.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-11-09
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