注册号:
Registration number:
ChiCTR-TNRC-14004694
注册号获得时间:
Date of releasing the registration number:
2014/05/25
注册号状态:
预注册
Registration Status:
Prospective registration
注册题目:
自体骨髓间充质干细胞静脉输注治疗视网膜色素变性的初步临床研究
Public title:
The preliminary clinical study of bone marrow mesenchymal stem cells infusion treatment of retinitis pigmentosa
研究课题的正式科学名称:
自体骨髓间充质干细胞静脉输注治疗视网膜色素变性的初步临床研究
Scientific title:
The preliminary clinical study of bone marrow mesenchymal stem cells infusion treatment of retinitis pigmentosa
研究课题代号(代码):
Study subject ID:
在其它机构的注册号:
Secondary ID:
申请注册联系人:
李世迎
研究负责人:
阴正勤
Applicant:
Li Shiying
Study leader:
Yin Zhengqin
申请注册联系人电话:
Applicant telephone:
+86 13648430819 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:
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:
Dept. Ophthalmology, Southwest Hospital, Gaotanyan Street 29, Shapingba District, Chongqing, China
Study leader's address:
Dept. Ophthalmology, Southwest Hospital, Gaotanyan Street 29, 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:
400038
申请人所在单位:
第三军医大学附属西南医院
Applicant's institution:
Southwest Hospital, Third Military Medical University
是否获伦理委员会批准:
否
Approved by ethic committee:
No
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:
Name of the ethic committee:
伦理委员会批准日期:
Date of approved by ethic committee:
研究实施负责(组长)单位:
第三军医大学附属西南医院
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:
Gaotanyan Street 29, Shapingba District, Chongqing, 400038 P.R China
试验主办单位(项目批准或申办者):
Secondary sponsor:
未填写任何试验主办单位。
No data added。
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:
retinitis pigmentosa
研究疾病代码:
Target disease code:
研究类型:
干预性研究
Study type:
Interventional
研究所处阶段:
临床预试验
Study phase:
Clinical pre-test
研究目的:
初步探讨自体骨髓间充质干细胞静脉输注治疗对视网膜色素变性患者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 puopose of this study was to determine the long-term safety and efficacy of autologous bone marrow mesenchymal stem cell infusion therapy a series patients of retinitis pigmentosa (RP), and explore new treatment modalities for the clinical treatment of retinitis pigmentosa.
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18-65周岁,性别不限。 3)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。 4)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(BCVA) ≥19且≤73个ETDRS字母(约等于Snellen视力表的20/400和20/40)。
Inclusion criteria
1. Patient has signed informed consent for retinal transplantation and is willing to return for follow-up visits;2. Age range 18 to 65 years,gender unlimited; 3.Patients with at least one eye (monocular) or both eyes suffering from impaired vision caused by retinitis pigmentosa; 4.Use the early treatment diabetic retinopathy (ETDRs) eye chart in 4 meters distance detection, best corrected visual acuity scores between 19 and 73 letter, including 19 and 73 (or the equivalent of about Snellen eyesight from 20/400 to 20/40).
排除标准:
1)年龄小于18周岁或大于65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:
从From2014-1-1至To
干预措施:
Interventions:
组别:
case series
样本量:
10
Group:
case series
Sample size:
干预措施:
自体骨髓间充质干细胞静脉输注
干预措施代码:
Intervention:
autologous bone marrow mesenchymal stem cell infusion therapy
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:
三甲
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
Outcome:
Early treatment of diabetic retinopathy eye chart(ETDRs)
指标中文名:
眼底照相及眼底荧光血管造影
Outcome:
Fluorescein angiography
指标中文名:
静态视野计
Outcome:
Static perimetry
指标中文名:
眼底光学相干断层扫瞄
Outcome:
Optical coherent tomography(OCT)
指标中文名:
闪光视网膜电图
Outcome:
Flash electroretinogram(FERG)
指标中文名:
闪光视觉诱发电位
Outcome:
Flash Visual Evoked Potentials(FVEP)
指标中文名:
多焦视网膜电图
Outcome:
mutifocal electroretinogram(MFERG)
指标中文名:
瞳孔光反射
Outcome:
Pupillary light reflex
采集人体标本:
Collecting sample(s)
from participants:
未填写任何采集标本。
No sample added。
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 岁 years
最大 Max age 65 岁 years
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
性别:
男女均可
Randomization Procedure (please state who generates the random number sequence and by what method):
Convenience selection
Gender:
Both
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:
第三军医大学附属西南医院
Data collection Institution:
Southwest Hospital, Third Military Medical University
资料管理单位:
第三军医大学附属西南医院
Data management Institution:
Southwest Hospital, Third Military Medical University
资料分析单位:
第三军医大学附属西南医院
Data analysis Institution:
Southwest Hospital, Third Military Medical University |