JPRN-C000000404已完成1 期
Phase I and IIa, Dose Escalation, Non-Randomized, Safety and Efficacy Evaluation Clinical Study for Angiogenic Gene Therapy to Treat Patients with Critical Limb Ischemia via Intramuscular Injection of Non-Transmissible Recombinant Sendai Virus Expressing Human Fibroblast Growth Factor-2 (FGF-2) Gene. - Phase I and IIa clinical study to treat clitical limb ischemia using SeV/dF-hFGF2
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
To the best of our knowledge, this is the first clinical trial of the use of a gene transfer vector based on rSeV. The single intramuscular administration of DVC1-0101 to PAD patients was safe and well tolerated, and resulted in significant improvements of limb function. Larger pivotal studies are warranted as a next step.
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. Subjected with severe allergy or its history. 2. Suspected malignant neoplasm (clinical, laboratory or imaging). 3. Subjects who have proliferative diabetic retinopathy or severe, non-proliferative retinopathy. 4. Subjects receiving chronic hemodialysis therapy. 5. Subjects who have severe heart dysfunction or faiure. 6. Subject who have hepatic dysfunction or cirrhosis. 7. Subjects with end stage renal disease (ESRD). 8. Subject who have active inflammatory diseases. 9. Subject who have recieved operative resection of malignant neoplasm 5 years prior to treatment. 10. Subjects who have experienced celebral hemorrhage or infarction 6 months prior to treatment. 11. Subjects with hematopoietic disorders. 12. Alcoholism and/or drug dependence. 13. Female subjects with pregnant or doubt of pregnacy. 14. Othors
研究者
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