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人胚胎视网膜细胞移植治疗视网膜色素变性的临床研究
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注册号:

Registration number:

ChiCTR-TNRC-08000193 

最近更新日期:

Date of Last Refreshed on:

2015-05-08 

注册时间:

Date of Registration:

2008-12-05 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

人胚胎视网膜细胞移植治疗视网膜色素变性的临床研究 

Public title:

Study in Retinal Cells Transplantation for Retinitis pigmentosa 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

人胚胎感光前体细胞移植治疗视网膜色素变性的安全性和有效性研究 

Scientific title:

Safety and Efficacy Study in Fetal Photoreceptor Progenitor Cells Transplantation for Retinitis Pigmentosa 

研究课题代号(代码):

Study subject ID:

第三军医大学第一附属医院临床创新基金2006A006 

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:

刘勇 

研究负责人:

阴正勤 

Applicant:

Liu Yong 

Study leader:

Yin Zhengqin 

申请注册联系人电话:

Applicant telephone:

+86 0 13110211600 

研究负责人电话:

Study leader's telephone:

+86 023 68754401 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

+86 023 65460711 

申请注册联系人电子邮件:

Applicant E-mail:

liuyy99@163.com 

研究负责人电子邮件:

Study leader's E-mail:

qinzyin@yahoo.com.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:

重庆市沙坪坝区西南医院眼科 

研究负责人通讯地址:

重庆市沙坪坝区西南医院眼科 

Applicant address:

29 Gaotanyan Street, Shapingba District, Chongqing, China 

Study leader's address:

29 Gaotanyan Street, Shapingba District, Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

400038 

研究负责人邮政编码:

Study leader's postcode:

400038 

申请人所在单位:

西南医院眼科 

Applicant's institution:

Dept. Ophthalmology, Southwest Hospital 

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:

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:

第三军医大学西南医院医学伦理委员会 

Name of the ethic committee:

Ethic Committee of Southwest Hospital, Third Military Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2008-05-08 

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:

第三军医大学第一附属医院 

Primary sponsor:

Southwest Hospital, Third Military Medical University 

研究实施负责(组长)单位地址:

重庆市沙坪坝区高滩岩西南医院 

Primary sponsor's address:

29 Gaotanyan Street, Shapingba District, Chongqing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

-

省(直辖市):

-

市(区县):

Country:

-

Province:

-

City:

单位(医院):

重庆市自然基金

具体地址:

重庆市渝北区新溉大道2号生产力大厦

Institution
hospital:

Chongqing Science and Technology Commission

Address:

Productivity Building,No.2,Xingai Ave.,Yubei District,Chongqing City

经费或物资来源:

第三军医大学第一附属医院临床创新基金2006A006 

Source(s) of funding:

(1) Innovation and Clinical Technology Fund of Southwest Hospital (No. 2006A006). (2) Nature Science Foundation of Chongqing, China 

研究疾病:

晚期视网膜色素变性 

Target disease:

Advanced retinitis pigmentosa 

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期临床试验 

Study phase:

研究目的:

评价人胚胎感光前体细胞同种异体移植治疗晚期视网膜色素变性疾病的安全性和有效性。 

Objectives of Study:

The puopose of this study was to determine the long-term safety and efficacy of transplanting human fetal photoreceptor progenitor cells into a series patients of advanced retinitis pigmentosa (RP) 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

1)自愿作为受试对象,患者签署知情同意书,且能按时随访。 2)年龄在18-50周岁,性别不限。 3)临床诊断为视网膜色素变性,双眼罹患。 4)手术眼矫正视力≤0.1(ETDRS视力表),视野半径≤10°,非手术眼视力或视野好于手术眼。 5)黄斑无增殖膜和水肿 6)屈光介质清晰 7)无其它眼底及视神经病变 

Inclusion criteria

1. Clinical condition, bilateral expression of advanced retinitis pigmentosa; 2. Age range 18 to 50 years; 3. Visual acuity is worse than 10/200 by ETDRS vision testing in the operated eye, or the radius of view is less than 100 by visual field testing. Vision in the non-operated eye must be better than the operated eye; 4. Patient has signed informed consent for retinal transplantation and is willing to return for follow-up visits; 5. Macular has no detectable gross changes either clinically or on fluorescein angiography. 

排除标准:

1)年龄小于18周岁或大于50周岁者。 2)妊娠及哺乳期妇女。 3)眼屈光介质混浊(如角膜白斑、白内障、玻璃体混浊等),影响眼底图像的获得 4)合并有其他眼底疾病者(如青光眼、白内障、葡萄膜炎、静脉阻塞等),影响疗效观察。 5)合并有严重的心血管、肝、肾和造血系统等原发性疾病、精神病。 6)全身或局部正在应用其它影响疗效评估的药物,如糖皮质激素。 7)近三个月进行过其他内眼手术。 

Exclusion criteria:

1. Patient has medical problems that have a high risk of general anesthesia, such as metabolic, cadiovascular, hematopoietic or psychological system disorders; 2. Women in menstruation, pregnancy, perinatal prtiod and baby nursing periods; 3. Any significant ocular disease that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome; 4. Patient who has a history of corneal leukoma, cataract, uveitis, Coat's disease, diabetic retinopathy, glaucoma, or vitreous opacities that prevents visualization of the posterior pole; 5. Participating in another ophthalmic clinical trial or use of any other investigational new drugs within 3 months before the start of study treatment; 6. Intraocular surgery within the last 3 months. 

研究实施时间:

Study execute time:

From2008-05-01To 2011-05-01 

干预措施:

Interventions:

组别:

感光前体细胞移植

样本量:

6

Group:

Group 2

Sample size:

干预措施:

胚胎感光前体细胞移植到病变视网膜下

干预措施代码:

Intervention:

fetal photoreceptor progenitor cells transplantation

Intervention code:

组别:

神经层视网膜细胞移植

样本量:

4

Group:

Group1

Sample size:

干预措施:

胚胎视网膜神经层细胞移植入病变视网膜下

干预措施代码:

Intervention:

fetal neuroretinal cells transplantation

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

第三军医大学西南医院 

单位级别:

3级甲等 

Institution
hospital:

Southwest Hospital, Third Military Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

静态视野计

指标类型:

主要指标 

Outcome:

Static perimetry

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

闪光视网膜电图(f-ERG)

指标类型:

主要指标 

Outcome:

Flash electroretinography

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

静态视野计

指标类型:

主要指标 

Outcome:

Multifocal electroretinography

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

视力

指标类型:

主要指标 

Outcome:

Snellen Visual acuity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼底光学相干断层扫瞄(OCT)

指标类型:

主要指标 

Outcome:

Optical coherent tomography

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼底照相及眼底荧光血管造影

指标类型:

主要指标 

Outcome:

Fluorescein angiography

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

瞳孔光反射

指标类型:

主要指标 

Outcome:

Pupillary light reflex

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

排斥率

指标类型:

次要指标 

Outcome:

Transplantation rejection

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:

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 50 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):

方便选择

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

Convenience selection

盲法:

Blinding:

none

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:

即时公开/Real time access

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):

第三军医大学附属西南医院

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

Southwest Hospital, Third Military Medical University

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:

第三军医大学附属西南医院

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

Southwest Hospital, Third Military Medical University

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2008-12-05
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