生物工程人类无细胞血管用于末期病患者的透析:两个单臂第二阶段试验
Jeffrey H Lawson1, Marc H Glickman2, Marek Ilzecki3
1Humacyte, Durham, NC, USA; Duke University, Durham, North Carolina, USA.
Lancet (London, England)
|May 21, 2016
概括
生物工程人类无细胞血管为末期脏疾病患者提供了有前途的透析选择,具有良好的安全性和功能性. 建议进行进一步的随机试验以证实这些发现.
科学领域:
- 生物医学工程
- 血管外科手术
- 肝脏病学
背景情况:
- 透析接入移植对于终期病 (ESRD) 患者的慢性血液透析至关重要.
- 传统的聚四乙烯 (PTFE) 移植面临诸如血栓,感染和内脏增生等挑战.
- 为了解决这些局限性,开发了一种新的生物工程人类细胞血管 (HCV).
研究的目的:
- 评估生物工程人类细胞血管的安全性和有效性.
- 评估结果,包括6个月和12个月无不良事件和通透率.
主要方法:
- 在美国和波兰的6个中心进行了2个单臂的临床试验.
- 有ESRD的成年患者获得了生物工程人类细胞血管以获得血液透析.
- 主要终点集中在安全性 (免疫反应,感染,机械失效) 和有效性 (主要,主辅助和二次通透性在6个月).
主要成果:
- 60名患者接受了HCV植入物,平均随访时间为16个月.
- 在82个患者年中发生了一次感染;没有观察到血管扩张或显著的管后出血.
- 在6个月后,初级通透率为63%,初级辅助通透率为73%,二级通透率为97%.
- 在12个月后,初级通透率降至28%,初级辅助通透率降至38%,二次通透率保持在89%.
结论:
- 生物工程的人类无细胞血管显示出有利的血液透析安全性和功能性能.
- 结果表明HCV是传统移植的可行替代品.
- 需要在随机对照试验中进行进一步的研究,以巩固这些发现.
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