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同种异体脐带间充质干细胞移植治疗视网膜色素变性的初步临床研究
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注册号:

Registration number:

ChiCTR-ONC-16008839 

最近更新日期:

Date of Last Refreshed on:

2016-07-14 

注册时间:

Date of Registration:

2016-07-14 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

同种异体脐带间充质干细胞移植治疗视网膜色素变性的初步临床研究 

Public title:

Clinical study of allogeneic human umbilical cord mesenchymal stem cell (UC-MSC) transplantation in treatment of retinal pigmentosa  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

同种异体脐带间充质干细胞移植治疗视网膜色素变性的初步临床研究 

Scientific title:

Clinical study of allogeneic human umbilical cord mesenchymal stem cell (UC-MSC) transplantation in treatment of retinal pigmentosa  

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:

李世迎 

研究负责人:

阴正勤 

Applicant:

Shiying Li 

Study leader:

Zhengqin Yin 

申请注册联系人电话:

Applicant telephone:

+86 023 68773097 

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:

 

申请注册联系人电子邮件:

Applicant E-mail:

shiying_li@126.com 

研究负责人电子邮件:

Study leader's E-mail:

qinzyin@aliyun.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:

重庆市沙坪坝区高滩岩正街29号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 Main Street, Shapingba District, Chongqing, China  

Study leader's address:

29 Gaotanyan Main Street, Shapingba District, Chongqing, 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:

重庆市沙坪坝区西南医院眼科 

Applicant's institution:

Southwest Hospital, Shapingba District, Chongqing, China  

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:

[2016]60 

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:

中国人民解放军第三军医大学第一附属医院伦理委员会  

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital, the Third Miliatry Medical University, Peoples Liberation Army  

伦理委员会批准日期:

Date of approved by ethic committee:

2013-06-02 

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:

重庆市沙坪坝区西南医院 

Primary sponsor:

Southwest Hospital, Shapingba District, Chongqing, China  

研究实施负责(组长)单位地址:

重庆市沙坪坝区高滩岩正街29号 

Primary sponsor's address:

29 Gaotanyan Main Street, Shapingba District, Chongqing, 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):

上海国联干细胞技术有限公司

具体地址:

上海市普陀区中江路879弄15号楼4层

Institution
hospital:

Shanghai United Stem Cell Technology Co.,Ltd

Address:

4th floor, Building 15, 879 nong, Zhongjiang Road, PuTuo District, Shanghai

经费或物资来源:

国家重点基础研究发展计划(973计划) 

Source(s) of funding:

Supported by the National Basic Research Program (973 Program)  

研究疾病:

视网膜色素变性 

Target disease:

retinal pigmentosa 

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:

初步探讨异体脐带间充质干细胞静脉输注治疗对视网膜色素变性是否有治疗作用及其安全性,为临床治疗视网膜色素变性探索新的治疗方式。 

Objectives of Study:

The purpose of this study was to determine the safety and therapeutic effect of intravenous transfusion of human umbilical cord mesenchymal stem cell (UC-MSC) in patients with retinal pigmentosa, and explore new treatment modalities for retinal pigmentosa. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续病例 

Study design:

Case series 

纳入标准:

(1)年龄18-65岁(包括18周岁和65周岁)已签署知情同意书的患者 (2)患者至少有一只眼(单眼)或双眼因患视网膜色素变性致视力受损 (3)已使用常规治疗方法无效或自愿选择脐带间充质干细胞移植治疗的RP患者 (4)研究眼必须在随访1时符合下列标准: 1)使用糖尿病性视网膜病变早期治疗(ETDRs)视力检查表在4米距离时 检测,最佳矫正视力分数在19个字母和73个字母之间,包括19和73(约相当于Snellen视力20/400至20/40) 2)研究眼视力下降是因为RP所致 

Inclusion criteria

1. Patients aging from 18 to 65 years who have signed informed consent for the clinical trial; 2. Patients who have at least one visually impaired eye caused by retinal pigmentosa; 3. Patients with retinal pigmentosa who can not be effectively treated with conventional therapies; 4. Eyes under following conditions: 1) Using the early treatment diabetic retinopathy (ETDRs) eye chart BCVA between 19-73 letters including 19 and 73 (corresponding to 20/400-20/40 in Snellen Chart); 2) Visual loss is caused by retinal pigmentosa. 

排除标准:

1.眼部的伴随情况/疾病 (1)研究眼有伴随疾病,并会阻碍研究治疗改善视力。 (2)任一只眼有活动性的眼内炎症(无论是轻微或更重的等级) (3)任一只眼有活动性感染(例如结膜炎、角膜炎、巩膜炎、眼色素膜炎,眼内炎等) (4)任一只眼有眼色素膜炎的病史 (5)研究眼存在可能影响研究结果解释、或可能导致视力损害的疾病,包括严重白内障、青光眼、视网膜血管阻塞、视网膜脱离、黄斑裂孔、玻璃体黄斑牵拉或任何原因的脉络膜新生血管(例如年龄相关性黄斑变性、眼组织胞浆菌病或病理性近视等) (6)任一只眼有虹膜新生血管形成 (7)患者为独眼或在随访1时非研究眼(对侧眼)的最佳矫正视力小于等于24个字母(约相当于Snellen视力20/320) 2.眼部治疗 研究眼有内眼手术史 3.全身情况或治疗 (1)中风、冠心病、心绞痛史及肾功能不全需做透析或肾移植,以及不适合参与临床试验的其它全身慢性疾病 (2)对荧光素钠过敏者 (3)药物未能控制的高血压(收缩压>140mmHg或舒张压>90mmHg) (4)凝血机能异常或目前应用抗凝药物(如阿斯匹林)治疗者 (5)目前或近期可能需要全身使用已知对晶状体、视网膜或视神经有毒 性的药物,包括氯喹/羟氯喹、吩噻嗪、乙胺丁醇、去铁敏和他莫昔芬等 (6)治疗前1个月(或为试验药物的5个半衰期时间,以长者为准)内参加过任何研究药物的临床研究 4.依从性 (1)不能配合观察不良事件和疗效 (2)不能遵守研究或随访流程 5.其他 (2)近期(6月内)有生育计划的女性 (3)妊娠或哺乳期妇女。 

Exclusion criteria:

1. Patient with concomitant eye conditions/diseases incuding: (1) Eyes with concomitant diseases which will interfere the visual improvement of the study; (2) Either eye has active intraocular inflammation regardless of the grade of severity; (3) Either eye has active infection (e.g. conjunctivitis, keratitis, scleritisuveitisophthalmia); (4) Either eye has a history of uveitis; (5) Any significant ocular disease that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome, including severe cataract, glaucoma, retinal blood vessels occlusion, retinal detachment, macular hole, vitreous-macula traction; (6) Either eye has iris neovascularization; (7) Patients who have only one functioning eye, or the best corrected vision of untreated eye scores less than 24 letters in ETDRS chart(corresponding to 20/320 in Snellen chart); 2. Eyes with history of intraocular surgeries; 3. Patients with systemic conditions including: (1) stroke, coronary heart disease, angina pectoris, renal insufficiency needing dialysis, and other systemic diseases that are not suitable to the clinical trial; (2) patients who are allergic to sodium fluorescein; (3) uncontrolled hypertension (systolic pressure>140mmHg,or diastolic pressure>90mmHg); (4) coaggulative function disorder or patients who are using anticoagulant drugs; (5) patients who are using or are going to systemically use drugs that are toxic to lens, retina, or optic nerve like hydroxychloroquine, phenothiazine, ethambutol, tamoxifen, etc.; (6) patients who attended other clinical trials of any medicine within 1 month (or within 5 half-life periods). 4. others: (1) patients who have maternity plan in 6 months; (2) women patients who are in pregnancy or lactation period. 

研究实施时间:

Study execute time:

From2016-07-25To 2017-12-31 

干预措施:

Interventions:

组别:

One cohort

样本量:

40

Group:

One cohort

Sample size:

干预措施:

UC-MSC移植

干预措施代码:

Intervention:

UC-MSC 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):

第三军医大学附属西南医院 

单位级别:

三级甲等 

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:

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:

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:

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:

眼底光学相干断层扫描

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:

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:

闪光视觉诱发电位

指标类型:

主要指标 

Outcome:

Flash Visual Evoked Potentials

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:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

静脉血

组织:

Sample Name:

Venous 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:

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:

房水

组织:

Sample Name:

Aqueous humour

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 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):

方便选择

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

Convenience selection

盲法:

Blinding:

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):

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:

 2016-07-14
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