Safety and Efficacy of Subretinal Transplantation of Clinical Human Embryonic Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Retinitis Pigmentosa
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Adverse events and serious adverse events occurred within 1 year after transplantation
研究概览
简要总结
This project intends to transplant a clinical level human embryonic stem cells derived retinal pigment epithelium into subretinal space to treat eetinitis pigmentosa(RP) diseases. Through the statistical analysis EDTRS, BCVA, OCT, ERG, Fluorescein angiography, Ophthalmic AB ultrasound changes between before and after the treatment to assess the efficacy and safety 0f RPE transplants to treat RP disease.
详细描述
This project intends to transplant a clinical level human embryonic stem cells derived retinal pigment epithelium into subretinal space to treat eetinitis pigmentosa(RP) diseases. Through the statistical analysis EDTRS, BCVA, OCT, ERG, Fluorescein angiography, Ophthalmic AB ultrasound changes between before and after the treatment to assess the efficacy and safety 0f RPE transplants to treat RP disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 18 and under 80 years of age, both gender, in good health.
- •Clinical diagnosis of retinitis pigmentosa, the results of eye electrophysiological examination accord with retinitis pigmentosa.
- •The BCVA of target eye will not be better than 20/
- •The BCVA of contralateral eye is not worse than 20/
- •Diopter is smaller than 8.00 D, axial 28 mm or less.
- •Voluntary as test subjects, signed informed consent, regular follow-up will be effected according to the specified time.
排除标准
- •Subject with other additional retinal diseases, like diabetic or hypertensive retinopathy vascular diseases.
- •Target eye ever have had a eye surgery;
- •Subject with active serious diseases of the digestive system, 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;
- •Have been ready for pregnancy during test, are lactating women;
- •Ready to birth of men during the test;
- •Subject with any immunodeficiency;
- •Subject in the immunosuppressive therapy in the current;
- •Subject with the tacrolimus or other large ring lactone class drug allergies;
- •Participate in any clinical subjects in nearly six months;
- •Has a history of alcohol or illicit drug abuse;
- •Poor adherence to complete studies;
- •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.).
研究组 & 干预措施
retinal pigment epitheliums transplantation
Transplant clinical-grade hESC derived retinal pigment epitheliums into subretinal of patients with retinitis pigmentosa.The dosage is 150000.
干预措施: Retinal pigment epitheliums transplantation (Biological)
结局指标
主要结局
Adverse events and serious adverse events occurred within 1 year after transplantation
时间窗: one year
The occurrence of adverse events (AE), severe adverse events (SAE), treatment-related adverse events (TEAE), and clinically significant vital signs during the study period.
次要结局
- Improvement of visual function(one year)
研究者
Qi Zhou
Director of Institute of zoology, chinese academy of sciences, and vice president of medical school， University of chinese academy of sciences
Chinese Academy of Sciences