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HPV抗原负载DC激活CTL治疗HPV感染的疗效观察和安全性评估
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注册号:

Registration number:

ChiCTR1800019532 

最近更新日期:

Date of Last Refreshed on:

2018-11-17 

注册时间:

Date of Registration:

2018-11-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

HPV抗原负载DC激活CTL治疗HPV感染的疗效观察和安全性评估 

Public title:

Efficacy and safety evaluation of HPV antigen loaded DC activated CTL in the treatment of HPV infection 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

HPV抗原负载DC激活CTL治疗HPV感染的疗效观察和安全性评估 

Scientific title:

Efficacy and safety evaluation of HPV antigen loaded DC activated CTL in the treatment of HPV infection 

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:

樊敏 

研究负责人:

赵振林 

Applicant:

Fan Min 

Study leader:

Zhao Zhenlin 

申请注册联系人电话:

Applicant telephone:

+86 15118052736 

研究负责人电话:

Study leader's telephone:

+86 13828895409 

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:

1011585915@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

zhaozl2006@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:

深圳市福田区笋岗西路3002号银华大厦16层1608 

研究负责人通讯地址:

深圳市福田区笋岗西路3002号银华大厦16层1608 

Applicant address:

Room 1608, Floor 16, Yinhua Building, 3002 Sungang Road West, Futian District, Shenzhen, Guangdong, China 

Study leader's address:

Room1608, Floor 16, Yinhua Building, 3002 Sungang Road West, Futian District, Shenzhen, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

518035 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

深圳市瑞普逊干细胞再生医学研究院 

Applicant's institution:

Shenzhen Ruipuxun Academy for Stem Cell & Regenerative 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:

RPX2018-1101 

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:

深圳市瑞普逊干细胞再生医学研究院伦理委员会 

Name of the ethic committee:

Ethics Committee of Shenzhen Ruipuxun Academy for Stem Cell & Regenerative Medicine 

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:

肖平 

Contact Name of the ethic committee:

Xiao Ping 

伦理委员会联系地址:

深圳市福田区笋岗西路3002号银华大厦16层 

Contact Address of the ethic committee:

Floor 16, Yinhua Building, 3002 Sungang Road West, Futian District, Shenzhen, Guangdong, 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:

深圳市瑞普逊干细胞再生医学研究院 

Primary sponsor:

Shenzhen Ruipuxun Academy for Stem Cell & Regenerative Medicine 

研究实施负责(组长)单位地址:

深圳市坪山区金辉路14号深圳市生物医药创新产业园区10号楼5层 

Primary sponsor's address:

Floor 5, Building 10, Shenzhen Biomedicine Innovation Industrial Park, 14 Jinhui Rood, Pingshan District, Shenzhen, Guangdong, 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):

广东省

市(区县):

深圳市

Country:

China

Province:

Guangdong

City:

Shenzhen

单位(医院):

深圳市瑞普逊干细胞再生医学研究院

具体地址:

深圳市坪山区金辉路14号深圳市生物医药创新产业园区10号楼5层

Institution
hospital:

Shenzhen Ruipuxun Academy for Stem Cell & Regenerative Medicine

Address:

Floor 5, Building 10, Shenzhen Biomedicine Innovation Industrial Park, 14 Jinhui Rood, Pingshan District, Shenzhen, Guangdong, China

经费或物资来源:

深圳市瑞普逊干细胞再生医学研究院 

Source(s) of funding:

Shenzhen Ruipuxun Academy for Stem Cell & Regenerative Medicine  

研究疾病:

HPV感染性疾病 

Target disease:

HPV infection 

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:

对HPV抗原负载DC活化CTL治疗HPV感染的疗效和安全性评估 

Objectives of Study:

To evaluate the efficacy and safety of CTL therapy activated by HPV antigen loaded DC in the treatment of HPV infection 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.高危HPV检测阳性 2 年龄30-55岁; 3.或最近6个月内宫颈高危型HPV经HC2检测至少1次为阳性者; 4.心肺肝肾重要器官功能良好; 5.无精神疾病和认知障碍; 6.自愿签署知情同意书者。 

Inclusion criteria

1. HPV test should be positive ,Conforming to diagnosis of cervical high risk HPV infection; 2. Aged 30 to 55 years; 3. Cervix high-risk type HPV HC2 inspecting at least 1 time for positive in the latest 6 months; 4. Heart, lung, liver and kidney function well; 5. signed informed consent. 

排除标准:

1.HPV DNA检测呈阴性; 2.生殖道炎症者(淋病、衣原体感染、念珠菌阴道炎、滴虫性阴道炎、细菌性阴道病等); 3.免疫功能低下(放化疗后,AIDS,SLE等); 4.患有严重的自身免疫疾病; 5.患者对细胞因子过敏; 6.哺乳期及妊娠期; 7.患有严重的感染性疾病; 8.合并有心血管、脑血管、肝、肾和造血系统等严重原发性疾病及精神病患者; 9.近三个月采取治疗HPV感染措施者; 10.近三个月参加其他临床试验的患者; 11.器官移植史; 12.没有签署知情同意书。 

Exclusion criteria:

1. Negative HPV DNA test; 2. Genital tract inflammation (gonorrhea, chlamydia, Candida vaginitis, Trichomonas vaginitis, Bacterial vaginal disease Etc.); 3. A weakened immune system (Radiation andchemotherapy after, AIDS, SLE Etc.); 4. Patient with severe autoimmune disease; 5. Allergic to cytokines; 6. Lactation and pregnancy; 7. Patient with a serious infectious disease; 8. With cardiovascular, cerebrovascular, liver, kidney andhematopoietic system andother serious primary diseases andpsychiatric patients; 9. Nearly three months treatment of HPV infection measures; 10. Nearly three months in other clinical trials; 11. History of organ transplantation; 12. mental illness and Cognitive impairment. 

研究实施时间:

Study execute time:

From2018-12-01To 2021-12-31 

干预措施:

Interventions:

组别:

试验组1

样本量:

150

Group:

Group 1

Sample size:

干预措施:

CTL注射液治疗( 自体细胞)

干预措施代码:

Intervention:

CTL Injection (Autogenous Cells)

Intervention code:

组别:

试验组2

样本量:

150

Group:

Group 2

Sample size:

干预措施:

CTL注射液治疗( 脐血细胞)

干预措施代码:

Intervention:

CTL Injection (Umbilical Cord Blood Cells)

Intervention code:

组别:

对照组

样本量:

150

Group:

Group 3

Sample size:

干预措施:

HPV抗原负载的DC免疫

干预措施代码:

Intervention:

HPV-DC vaccination

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山西 

市(区县):

太原 

Country:

China 

Province:

Shanxi 

City:

Taiyuan 

单位(医院):

山西医科大学第二医院 

单位级别:

三级甲等 

Institution
hospital:

The second hospital of Shanxi Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

广东省 

市(区县):

深圳市 

Country:

China 

Province:

Guangdong 

City:

Shenzhen 

单位(医院):

深圳市第二人民医院 

单位级别:

三级甲等 

Institution
hospital:

Shenzhen Second People Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

广东省 

市(区县):

深圳市 

Country:

China 

Province:

Guangdong 

City:

Shenzhen 

单位(医院):

暨南大学附属深圳华侨医院 

单位级别:

三级综合 

Institution
hospital:

Jinan University Affiliated overseas Chinese Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

山西 

市(区县):

太原 

Country:

China 

Province:

Shanxi 

City:

Taiyuan 

单位(医院):

山西贞德妇儿医院 

单位级别:

二级专科 

Institution
hospital:

Shanxi Zhende Women and Children's Hospital  

Level of the institution:

Secondary Hospital 

测量指标:

Outcomes:

指标中文名:

HPV阴转率

指标类型:

主要指标 

Outcome:

negative conversion rate of HPV

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

HC2检测

指标类型:

主要指标 

Outcome:

HC2 test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

HPV抗原检测

指标类型:

主要指标 

Outcome:

HPV Ag test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

HPV抗体检测

指标类型:

主要指标 

Outcome:

HPV Ab test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CD3+CD8+CD28+ T 细胞

指标类型:

主要指标 

Outcome:

CD3+CD8+CD28+ T cells

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:

外周血

组织:

Sample Name:

Peripheral blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

脐血

组织:

Sample Name:

Umbilical cord 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 30 years
最大 Max age 55 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

随机方法采用随机函数产生的随机数字

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

The random numbers are generated by statistical teacher using uniformly distributed random functions

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):

在事先征得研究牵头单位同意的情况下进行关于本研究成果的交流

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

Conducting any exchanges and publication of the study results must get the prior approval of the research lead agency.

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:

每个入选病例必须完成病例报告表;完成的病例报告表由临床监查员审查后,移交数据管理员,进行数据的管理工作。

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

Each selected case must complete the case report form. The completed case reports form are reviewed by the clinical examiner and handed over to the data administrator for data management.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-11-17
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