JPRN-UMIN000010260已完成1 期
The Clinical Study for Neuroprotective Gene Therapy to Treat Patients with Retinitis Pigmentosa via Subretinal Injection of The 3rd Generation of Recombinant Simian Immunodeficiency Virus (SIVagm) Vector Expressing Human Pigment Epithelium-Derived Factor (hPEDF) Gene - The Clinical Study for Neuroprotective Gene Therapy to Treat Patients with Retinitis Pigmentosa
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40years-old 至 ot applicable(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Human immunodeficiency virus (HIV) antibody-positive subjects 2. Blindness 3. Subjects with a macular complication of retinitis pigmentosa (eg: macular degeneration,macular edema, etc.) 4. A past history of glaucoma 5. Subjects with retinal or subretinal disorders 6. Subjected with severe allergy or its history. 7. Subjects receiving chronic hemodialysis therapy 8. Subjects who have severe heart dysfunction or faiure 9. Subjects who have hepatic dysfunction or cirrhosis 10. Subject who have active inflammatory diseases 11. Subjects who have experienced celebral hemorrhage or infarction 6 months prior to treatment 12. Subjects with hematopoietic disorders 13. Alcoholism and/or drug dependence 14. Female subjects with pregnant or doubt of pregnancy 15. Subjects who are diagnosed with cancer or are suspected to cancer 16. Subject who have recieved operative resection of malignant neoplasm 5 years prior to treatment 17. Subjects who disapprove of birth control during at least 12 months after the vector administration 18. Subjects who take the antiviral drug at the registration 19. Others
研究者
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