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自体气道基底细胞移植治疗特发性肺纤维化的临床研究
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注册号:

Registration number:

ChiCTR1800018335 

最近更新日期:

Date of Last Refreshed on:

2018-09-12 

注册时间:

Date of Registration:

2018-09-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

自体气道基底细胞移植治疗特发性肺纤维化的临床研究 

Public title:

A clinical trial for autologous airway basal cell transplantation in treatment of idiopathic pulmonary fibrosis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

自体气道基底细胞移植治疗特发性肺纤维化的单中心自身前后对照临床研究 

Scientific title:

A before-after controlled study for autologous airway basal cell transplantation in treatment of idiopathic pulmonary fibrosis 

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:

陆奕 

研究负责人:

陆奕 

Applicant:

Yi Lu 

Study leader:

Yi Lu 

申请注册联系人电话:

Applicant telephone:

+86 18930172985 

研究负责人电话:

Study leader's telephone:

+86 18930172985 

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:

luyi0718@126.com 

研究负责人电子邮件:

Study leader's E-mail:

luyi0718@126.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:

上海市宜山路600号 

研究负责人通讯地址:

上海市宜山路600号 

Applicant address:

600 Yishan Road, Xuhui District, Shanghai, China 

Study leader's address:

600 Yishan Road, Xuhui District, 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:

上海市第六人民医院 

Applicant's institution:

Shanghai Sixth People's Hospital 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

上海市第六人民医院 

Primary sponsor:

Shanghai Sixth People's Hospital 

研究实施负责(组长)单位地址:

上海市宜山路600号 

Primary sponsor's address:

600 Yishan 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):

上海市第六人民医院

具体地址:

上海市宜山路600号

Institution
hospital:

Shanghai Sixth People's Hospital

Address:

600 Yishan Road, Shanghai

经费或物资来源:

上海市第六人民医院院级课题 

Source(s) of funding:

Foundation of Shanghai Sixth People's Hospital 

研究疾病:

特发性肺纤维化 

Target disease:

idiopathic pulmonary fibrosis 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

1.建立支气管镜下自体气道基底细胞的回输策略。 2.评价自体气道基底细胞移植治疗IPF的安全性和有效性。 

Objectives of Study:

To establish a bronchoscopy autologous airway basal cell transplantation strategy. To assess the safety and effectiveness of autologous airway basal cell in treatment of idiopathic pulmonary fibrosis. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

① 40 岁≤年龄≤75 岁,男女不限; ② 肺功能检查弥散功能(DLco)中重度减低; ③ 肺 CT 检查有间质性肺炎的影像表现; ④ 充分被告知试验目的、方法及可能出现的不舒适,同意参加试验,并签署知情同意书; ⑤ 依从性好,愿意按照方案的要求用药并按时随访检查; ⑥ 能够理解并完成肺功能及支气管镜检查操作。 

Inclusion criteria

1. Aged 40-75 years old; 2. moderate or sevre decrease of DLco; 3. Interstitial lung disease change on lung CT; 4. Agree to join clinical trial and signature on informed consent; 5. Has a good compliance,can complete the examination and treatment; 6. Can complete the bronchoscopy and lung function examination. 

排除标准:

① 不能耐受细胞移植治疗者; ② 有明显肺部感染需抗感染治疗者(就诊前 4 周内呼吸道感染者及全身感染者); ③ 合并恶性肿瘤者; ④ 有严重的其它系统疾病和脏器功能不全; ⑤ 孕妇、哺乳期妇女或近期有生育计划、不能采取有效避孕措施者; ⑥ 研究者认为有任何不适合入选情况者。 

Exclusion criteria:

1. Can not tolerate the cell transplantation; 2. Has lung infection and need antibiotics treatment; 3. Combined with malignant tumor; 4. Has other disease or organ dysfunction; 5. Pregnant woman or had plan to have a baby; 6. Researcher's disagreement. 

研究实施时间:

Study execute time:

From2019-01-01To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2019-01-01To 2021-06-30 

干预措施:

Interventions:

组别:

试验组

样本量:

23

Group:

Case series

Sample size:

干预措施:

自体气道基底细胞移植

干预措施代码:

Intervention:

autologous airway basal cell transplantation

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):

上海市第六人民医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Sixth People's Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

用力肺活量

指标类型:

主要指标 

Outcome:

forced vital capacity

Type:

Primary 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:

气道基底细胞

组织:

Sample Name:

airway basal cell

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 40 years
最大 Max age 75 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):

no

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):

http://www.chictr.org.cn/; 2022.6.30

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

http://www.chictr.org.cn/; 2022.6.30

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:

电子采集和管理系统(Excel)

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

Electronic Data Capture (Excel)

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-09-12
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