ChiCTR-OCB-15007055 版本V1.1 版本创建时间2015/9/22 10:42:03 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR-OCB-15007055 

最近更新时间:

Date of Last Refreshed on:

2015/9/14 16:10:54 

注册号状态:

预注册  

Registration Status:

Prospective registration  

填写语言:

中文和英文  

Language:

Chinese And English  

注册题目:

临床级别人胚胎干细胞来源的视网膜色素上皮细胞视网膜下腔移植治疗视网膜色素变性疾病的临床研究 

Public title:

Clinical study of subretinal transplantation of clinical human embryo stem cell derived retinal pigment epitheliums in treatment of retinitis pigmento diseases 

注册题目简写:

 

Public title acronym:

 

研究课题的正式科学名称:

临床级别人胚胎干细胞来源的视网膜色素上皮细胞视网膜下腔移植治疗视网膜色素变性疾病的临床研究 

Scientific title:

Clinical study of subretinal transplantation of clinical human embryo stem cell derived retinal pigment epitheliums in treatment of retinitis pigmento diseases 

研究课题的正式科学名称简写:

 

Scientific title acronym:

 

研究课题代号(代码):

Study subject ID:

中国科学院战略性先导科技专项XDA01030000 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

郝捷 

研究负责人:

周琪 

Applicant:

Hao Jie 

Study leader:

Zhou Qi 

申请注册联系人电话:

Applicant telephone:

+86 010 62558737 

研究负责人电话:

Study leader's telephone:

+86 010 64807299 

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:

haojie@ioz.ac.cn 

研究负责人电子邮件:

Study leader's E-mail:

zhouqi@ioz.ac.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:

北京市海淀区北四环西路25-2 北京干细胞库 

研究负责人通讯地址:

北京市朝阳区北辰西路1号院5号 

Applicant address:

25-2 North 4th Ring, Haidian District, Beijing 

Study leader's address:

1-5 West Beichen Road, Chaoyang District, Beijing 

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:

中国科学院动物研究所 

Applicant's institution:

Institute of zoology, chinese academy of sciences 

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:

NA 

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:

中国科学院动物研究所伦理委员会 

Name of the ethic committee:

Ethics committee of Institute of zoology, chinese academy of sciences 

伦理委员会批准日期:

Date of approved by ethic committee:

 

国家FDA批准文号:

Approved No. of SFDA:

国家FDA批准附件:

Approved file of SFDA:

国家FDA批准日期:

Date of approved by SFDA:

研究实施负责(组长)单位:

中国科学院动物研究所 

Primary sponsor:

Institute of zoology, chinese academy of sciences 

研究实施负责(组长)单位地址:

北京市朝阳区北辰西路1号院5号 

Primary sponsor's address:

1-5 West Beichen Road, Chaoyang District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国科学院动物研究所

具体地址:

北京市朝阳区北辰西路1号院5号

Institution
hospital:

Institute of zoology, chinese academy of sciences

Address:

1-5 Beichen West Road, Chaoyang District, Beijing

经费或物资来源:

中国科学院战略性先导科技专项(XDA01030000) 

Source(s) of funding:

Strategic Priority Research Program of the Chinese Academy of Sciences (XDA01030000) 

研究疾病:

视网膜色素变性疾病 

Target disease:

retinitis pigmento diseases 

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:

通过临床级别人胚胎干细胞来源的视膜色素上皮细胞(human embryo stem cell derived retinal pigment epitheliums,hESC-RPE)视网膜下腔移植治疗视网膜色素变性,来评价其安全性和有效性,为临床治疗视网膜色素变性探索新的治疗方式。 

Objectives of Study:

The puopose of this study was to assess the fety effect of the clinical human embryo stem cell derived retinal pigment epitheliums cell therapy on retinitis pigmento diseases, explore new treatment method for retinitis pigmento diseases. 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1.年龄18-70周岁,性别不限,健康状况良好。2.临床诊断为视网膜色素变性,眼电生理检查结果符合视网膜色素变性。3.术眼最佳矫正视力将不优于20/400。4.对侧眼最佳矫正视力不差于20/400。5.屈光度大于-8.00D,眼轴≤28mm。6.自愿作为受试对象,签署知情同意书,能按规定时间定期随访。 

Inclusion criteria

1. Any age 18-70 years of age, gender, in good health. 2. Clinical diagnosis of retinitis pigmento, the results of eye electrophysiological examination accord with retinitis pigmento. 3. The BCVA of target eye will not be better than 20/400. 4. The BCVA of contralateral eye is not worse than 20/400. 5. Diopter is greater than 8.00 D, axial 28 mm or less. 6. Voluntary as test subjects, signed informed consent, regular follow-up will be effected according to the specified time. 

排除标准:

1.患有除RP之外的其他眼科疾病,如年龄相关性黄斑变性、糖尿病性视网膜病变、视神经病变,晶状体显著混浊、青光眼、葡萄膜炎、视网膜脱离等。2.术眼内眼手术史。3.有活动性严重消化系统疾病,肝肾功能损害(ALT/AST)>1.5或任何已知的肝疾病,肌酸>1.3 mg/dL)和/严重的全身性疾病(如心血管系统、呼吸系统、神经系统、内分泌系统、泌尿生殖系统疾病等),恶性肿瘤病史。4.已经妊娠、试验期间准备妊娠,正在授乳的女性;试验期间准备生育的男性。5.任何免疫缺陷。6.当前在进行免疫抑制治疗。7.对他克莫司或其他大环内酯类药物过敏者。8.在近6个月内参加任何临床试验者。9.有酒精或违禁药物滥用史。10.依从性差,难以完成研究的患者。11.研究者认为可能存在增加受试者危险性或干扰临床试验的任何情况(如患者易发生精神紧张、抑郁、精神疾病、认知功能障碍等)。 

Exclusion criteria:

1. Subject with other additional retinal diseases, like diabetic or hypertensive retinopathy vascular diseases. 2. Target eye ever have had a eye surgery; 3. Subject with active serious diseases of the digestive tem, liver kidney impairment (ALT/AST) > 1.5 or any known liver disease, creatine > 1.3 mg/dL) and/serious temic diseases, such as cardiovascular tem, respiratory tem, nervous tem, endocrine tem urogenital tem diseases, etc.), the history of malignancy; 4. Have been ready for pregnancy during test, are lactating women;Ready to birth of men during the test; 5. Subject with any immunodeficiency; 6. Subject in the immunosuppressive therapy in the current; 7. Subject with the tacrolimus or other large ring lactone class drug allergies; 8. Participate in any clinical subjects in nearly six months; 9. Has a history of alcohol or illicit drug abuse; 10. Poor adherence to complete studies; 11. Researchers believe that there may be an increased risk subjects or interfere with the clinical trials of any situation (such as when a patient is prone to mental tension, depression, mental illness, cognitive dysfunction, etc.). 

研究实施时间:

Study execute time:

From2015-09-20To 2017-12-20 

干预措施:

Interventions:

组别:

One cohort

样本量:

10

Group:

One cohort

Sample size:

干预措施:

视网膜色素上皮细胞移植

干预措施代码:

Intervention:

retinal pigment epithelium transplantation

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京同仁医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Tongren Hospitol,Capital Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

糖尿病性视网膜病变早期治疗视力检查表

指标类型:

主要指标 

Outcome:

Early treatment of diabetic retinopathy eye chart (ETDRs)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

最佳矫正视力(BCVA)

指标类型:

主要指标 

Outcome:

Best corrected 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:

眼底光学相干断层扫瞄

指标类型:

主要指标 

Outcome:

Optical coherent tomography (OCT)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼电图

指标类型:

主要指标 

Outcome:

Electro-oculogram

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

多焦视网膜电图

指标类型:

主要指标 

Outcome:

mutifocal electroretinogram (MFERG)

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

指标类型:

主要指标 

Outcome:

Flash electroretinogram (FERG)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

微视野检查

指标类型:

主要指标 

Outcome:

The micro view inspection

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼科AB超

指标类型:

主要指标 

Outcome:

Ophthalmic AB ultrasound

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:

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:

标本中文名:

尿液

组织:

Sample Name:

urine

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 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

UTN(全球唯一识别码):

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

Data collection Institution:

资料管理单位:

Data management Institution:

资料分析单位:

Data analysis Institution:

注册人:

Name on Registration:

 2015-09-13