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脐带间充质干细胞治疗放射性肺纤维化的临床试验
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注册号:

Registration number:

ChiCTR1800019309 

最近更新日期:

Date of Last Refreshed on:

2018-11-11 

注册时间:

Date of Registration:

2018-11-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

脐带间充质干细胞治疗放射性肺纤维化的临床试验 

Public title:

Clinical Trial of Umbilical Cord Mesenchymal Stem Cell Therapy in Radiation-induced Pulmonary Fibrosis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

脐带间充质干细胞治疗放射性肺纤维化的临床试验 

Scientific title:

Clinical Trial of Umbilical Cord Mesenchymal Stem Cell Therapy in Radiation-induced 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:

陈艳 

研究负责人:

董坚 

Applicant:

Chen Yan 

Study leader:

Dong Jian 

申请注册联系人电话:

Applicant telephone:

+86 15398578769 

研究负责人电话:

Study leader's telephone:

+86 13888230968 

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:

chenyanyn@163.com 

研究负责人电子邮件:

Study leader's E-mail:

dongjian18@yahoo.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:

云南省昆明市昆州路519号 

研究负责人通讯地址:

云南省昆明市昆州路519号 

Applicant address:

519 Kunzhou Road, Kunming, Yunnan, China 

Study leader's address:

519 Kunzhou Road, Kunming, Yunnan, China 

申请注册联系人邮政编码:

Applicant postcode:

650118 

研究负责人邮政编码:

Study leader's postcode:

650118 

申请人所在单位:

云南省肿瘤医院/昆明医科大学第三附属医院 

Applicant's institution:

Yunnan Tumor Hospital /The Third Affiliated Hospital of Kunming 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:

[2018]YJZ201808 

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:

云南省肿瘤医院伦理委员会 

Name of the ethic committee:

Yunnan Tumor Hospital Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-08-27 

伦理委员会联系人:

许玉玲 

Contact Name of the ethic committee:

Xu Yu-Lin 

伦理委员会联系地址:

云南省昆明市昆州路519号 

Contact Address of the ethic committee:

519 Kunzhou Road, Kunming, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0871-68185656-2804 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

ynzlyyll@163.com 

研究实施负责(组长)单位:

云南省肿瘤医院/昆明医科大学第三附属医院 

Primary sponsor:

Yunnan Tumor Hospital /The Third Affiliated Hospital of Kunming Medical University 

研究实施负责(组长)单位地址:

云南省昆明市昆州路519号 

Primary sponsor's address:

519 Kunzhou Road, Kunming, Yunnan, 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):

云南省

市(区县):

昆明市

Country:

China

Province:

Yunnan

City:

Kunming

单位(医院):

云南省肿瘤医院/昆明医科大学第三附属医院

具体地址:

云南省昆明市昆州路519号

Institution
hospital:

Yunnan Tumor Hospital /The Third Affiliated Hospital of Kunming Medical University

Address:

519 Kunzhou Road, Kunming, China

经费或物资来源:

1)云南省细胞治疗技术转化医学重点实验室(云南省重点实验室建设项目,2015DG034,400万); 2)昆明市干细胞临床转化领域院士工作站(昆明市科技局重点项目,200 万);3)人脐带间充质干细胞对肿瘤干细胞影响的研究(昆明市科技局重点项目,100万);4)云南省细胞工程转化医学研究所(云南省医疗卫生内设研究机构项目,360万);5)云南省卫生系统领军人才培养计划(云南省卫生系统人才培养计划) 

Source(s) of funding:

Project supported by the Fund of Key Laboratory of Yunnan Province (No. 2015DG034), the Fund of Academician workstation of stem cell clinical transformation in Kunming, etc. 

研究疾病:

放射性肺纤维化 

Target disease:

Radiation-induced Pulmonary Fibrosis 

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:

I期+II期 

Study phase:

1-2 

研究目的:

评价临床级脐带间充质干细胞移植治疗放射性肺纤维化的安全性和有效性。 

Objectives of Study:

To investigate the safety and efficacy of umbilical cord mesenchymal stem cells (MSCs) infusion in the treatment ofRadiation-induced Pulmonary Fibrosis.  

药物成份或治疗方案详述:

脐带间充质干细胞制剂, 50ml/袋, 1×10^8/人,每隔1周输注1次,分别输注3次。 

Description for medicine or protocol of treatment in detail:

clinical grade umbilical cord mesenchymal stem cells, 50ml/ bag. The low-dose group will receive 1x10^8/person UC-MSCs delivered via peripheral intravenous infusion, once every other week, a total of three times. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1) 性别不限,年龄18-70岁; 2) 有明确的恶性肿瘤病史; 3)至少3 个月前有明确的胸部放射治疗病史; 4)确诊放射性肺纤维化; 5)签署知情同意书。 

Inclusion criteria

1) Male or female aged 18-70 years old; 2) Subjects with a clear history of malignancy; 3) Subjects with a clear history of chest radiation therapy at least 3 months earlier; 4) Subjects diagnosed as chronic phase of radiation-induced pneumonitis or radiation-induced pulmonary fibrosis stage (see Annex 3 for diagnosis); 5) Subjects signed informed consent. 

排除标准:

1)怀孕、哺乳的育龄妇女; 2)梅毒、HIV 抗体阳性患者; 3)近1月有明显感染者; 4)患有以下任何一种肺部疾病:活动性肺结核、肺栓塞、气胸、多发巨大肺大疱、哮喘未控制、重症肺炎、慢支炎急性发作、AECOPD 或重度和/或极重度 COPD 等; 5)患有严重的其他系统疾病,如心肌梗死,不稳定性心绞痛等,肝硬化,急性肾小球肾炎等; 6)无进展生存期(PFS)小于 0.5 年,Karnofsky 评分小于 60 分; 7)有严重的肝肾功损害; 8)任何原因造成的白细胞减少症(白细胞小于4x10^9/L )或粒细胞缺乏症(白细胞小于 1.5x10^9/L或中性粒细胞小于0.5x10^9/L)患者 8)有精神病史或自杀危险者,有癫痫病病史或其他中枢神经系统疾病病史; 9)12-导心电图显示具有严重的心律失常(如室性心动过速、频发室上性心动过速、房颤、房扑等)或心脏 II 度及 II 度以上传导异常; 10)有酒精或违禁药物滥用史; 11)入选前 3 个月内已经接受任何其他临床试验的患者; 12)依从性差,难以完成研究的患者; 13)研究者认为其他不合适的情况。研究者认为可导致参加研究不符合受试者的最佳利益或可能阻止、限制或混淆方案规定的安全性或有效性评估的任何情况。 

Exclusion criteria:

1) Women of childbearing age at the stage of pregnancy or lactation, or those without taking effective contraceptive measures; 2) Subjects with syphilis or HIV positive antibody; 3) Subjects with infection aggravated within the past month; 4) Subjects suffering from any of the following pulmonary diseases: active tuberculosis, pulmonary embolism, pneumothorax, multiple huge bullae, uncontrolled asthma, severe pneumonia, acute exacerbation of chronic bronchitis, AECOPD, severe and / or extremely severe COPD, etc.; 5) Subjects suffering from other serious diseases, such as myocardial infarction, unstable angina, cirrhosis, and acute glomerulonephritis; 6) Subjects with progression-free survival (PFS) less than 0.5 years or Karnofsky performance scores less than 60 points; 7) Subjects with leukopenia (WBC less than 4x10^9/L) or agranulocytosis (WBC less than 1.5x10^9/L or neutrophils less than 0.5x10^9 / L) caused by any reason; 8) Subjects with severe renal impairment, serum creatinine> 1.5 times the upper limit of normal; 9) Subjects with liver disease or liver damage: ALT, AST, total bilirubin> 2 times the upper limit of normal; 10) Subjects with a history of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders; 11) Subjects with severe arrhythmias (such as ventricular tachycardia, frequent superventricular tachycardia, atrial fibrillation, and atrial flutter, etc.) or cardiac degree II or above conduction abnormalities displayed via 12-lead ECG; 12) Subjects with a history of alcohol or illicit drug abuse; 13) Subjects accepted by any other clinical trials within 3 months before the enrollment; 14) Subjects with poor compliance, difficult to complete the study; 15) Any other conditions that might increase the risk of subjects or interfere with the clinical trial. 

研究实施时间:

Study execute time:

From2019-01-01To 2021-12-22 

征募观察对象时间:

Recruiting time:

From2019-01-01To  

干预措施:

Interventions:

组别:

UC-MSC治疗组

样本量:

12

Group:

UC-MSC treatment group

Sample size:

干预措施:

人脐带间充质干细胞治疗组的输注细胞量为1x10^8个细胞/人,通过静脉输注,每隔1周输注1次,分别输注3次

干预措施代码:

Intervention:

Human umbilical cord MSCs are transplanted by intravenous infusion(1×10^8/person) once every other week, a total of three times.

Intervention code:

组别:

对照组

样本量:

12

Group:

Control group

Sample size:

干预措施:

常规治疗组

干预措施代码:

Intervention:

Patients will receive the conventional treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

云南省 

市(区县):

昆明市 

Country:

China 

Province:

Yunnan 

City:

 

单位(医院):

云南省肿瘤医院/昆明医科大学第三附属医院 

单位级别:

省级医院 

Institution
hospital:

Yunnan Tumor Hospital /The Third Affiliated Hospital of Kunming Medical University  

Level of the institution:

the Provincial Level Hospital 

测量指标:

Outcomes:

指标中文名:

安全性结局指标

指标类型:

主要指标 

Outcome:

Safety Evaluation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疗效结局指标

指标类型:

次要指标 

Outcome:

Composite indicators of UC-MSC on Radiation-induced Pulmonary Fibrosis.

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

随机数字表

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

randomization digit table

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

使用ResMan共享原始数据

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

ResMan(www.medresman.org)

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:

病例记录表+基于互联网的EDC系统

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

Case Record Form plus 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:

 2018-11-05
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