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.
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).
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:
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作者: 雪山飞狐 时间: 2014-6-19 21:23