NCT02749734Unknown1 期
Clinical Study of Subretinal Transplantation of Human Embryo Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Macular Degeneration Diseases
Southwest Hospital, China1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2015年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of participants with Treatment-Related Adverse Events [Safety and Tolerability]
研究概览
简要总结
The purpose of this study was to determine the safety and therapeutic effect of sub-retinal transplantation of human embryo stem cell derived retinal pigment epitheliums (hESC-RPE) in patients with macular degeneration diseases, and explore new treatment modalities for macular degeneration diseases (Age-related macular degeneration and Stargardt's macular dystrophy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aging from 18 to 75 years
- •must have signed informed consent
- •At least one visually impaired eye caused by macular degeneration diseases
- •Can not be effectively treated with conventional therapies
- •Best corrected visual acuity scores between 19 and 73 letter in ETDRs (early treatment diabetic retinopathy ) eye chart , including 19 and 73 (or the equivalent of Snellen eyesight from 20/400 to 20/40)
- •Visual loss caused by macular degeneration diseases
排除标准
- •Eyes with concomitant diseases which will interfere the visual improvement of the study
- •Active intraocular inflammation regardless of the grade of severity
- •Active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, ophthalmia)
- •History of uveitis
- •Severe cataract, glaucoma, retinal blood vessels occlusion, retinal detachment, macular hole, vitreous-macula traction
- •Iris neovascularization
- •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)
- •History of intraocular surgery
- •Severe systemic diseases: Stroke, coronary heart disease, angina pectoris, renal insufficiency needing dialysis
- •Allergic to sodium fluorescein
- •Uncontrolled hypertension (systolic pressure>140mmHg,or diastolic pressure>90mmHg)
- •Coagulative function disorder
- •System administration of drugs that are toxic to lens, retina, or optic nerve like hydroxychloroquine, phenothiazine, ethambutol, tamoxifen, etc.
- •Involved in other clinical trials of any medicine within 1 month (or within 5 half-life periods)
- •Have maternity plan in 6 months
- •In pregnancy or lactation period.
研究组 & 干预措施
hESC-RPE
Experimental
Subretinal transplantation of Human embryo stem cell derived retinal pigment epitheliums
干预措施: Subretinal transplantation (Procedure)
结局指标
主要结局
Number of participants with Treatment-Related Adverse Events [Safety and Tolerability]
时间窗: up to 12 months
Patients with Treatment-Related Adverse Events caused by local rejection of implanted cells or systemic immunosuppression treatment
次要结局
- Flash Electroretinogram (FERG)(up to 12 months)
- Visual Field as examined by Static perimetry(up to 12 months)
- Number of Early Treatment Diabetic Retinopathy (ETDR ) letters participants can recognize(up to 12 months)
- Amplitude and Latency of Flash Visual Evoked Potentials (FVEP)(up to 12 months)
- Multifocal Electroretinogram (MFERG)(up to 12 months)
研究者
ZhengQin Yin
Professor
Southwest Hospital, China
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
CNS10-NPC for the Treatment of RPRetinitis PigmentosaNCT04284293Cedars-Sinai Medical Center16
进行中（未招募）
1 期
Safety and Efficacy of Subretinal Transplantation of Clinical Human Embryonic Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Retinitis PigmentosaRetinitis PigmentosaNCT03944239Qi Zhou25
Unknown
1 期
Subretinal Transplantation of Retinal Pigment Epitheliums in Treatment of Age-related Macular Degeneration DiseasesDry Age-related Macular DegenerationNCT02755428Chinese Academy of Sciences10
Unknown
1 期
Study of Subretinal Implantation of Human Embryonic Stem Cell-Derived RPE Cells in Advanced Dry AMDDry Macular DegenerationGeographic AtrophyNCT02590692Regenerative Patch Technologies, LLC16
招募中
2 期
A Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GAlette); Adaptive Optics (AO) Retinal Imaging Substudy in Association With Study GR44251Geographic AtrophyNCT05626114Genentech, Inc.60