The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes - Executive summary
The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes - Executive summary
复制标题
DOI：
10.1111/j.1399-3089.2009.00547.x
复制
发表时间：
2009-07-01
影响因子：
3.9
通讯作者：
Pierson, Richard N., III
中科院分区：
文献类型：
--
作者：
Hering, Bernhard J.;Cooper, David K. C.;Pierson, Richard N., III
国际异种移植协会胰岛异种移植共识声明描述了在1型糖尿病中进行猪胰岛产品临床试验的条件。第1章回顾了异种移植临床试验国际监管框架定义的关键伦理要求和进展。第2章至第7章提供了关于来源猪、猪胰岛产品生产和放行检测、证明临床试验合理性所需的临床前疗效和并发症数据、预防猪内源性逆转录病毒传播的策略、临床试验的患者选择和知情同意的深入和商定的建议。计划在一年内根据研究进展、监管框架的变化以及发表后提交的意见更新这一初步共识声明。
The International Xenotransplantation Association islet xenotransplantation consensus statement describes the conditions for undertaking clinical trials of porcine islet products in type 1 diabetes. Chapter 1 reviews the key ethical requirements and progress toward the definition of an international regulatory framework for clinical trials of xenotransplantation. Chapters 2 to 7 provide in depth and agreed-upon recommendations on source pigs, pig islet product manufacturing and release testing, preclinical efficacy and complication data required to justify a clinical trial, strategies to prevent transmission of porcine endogenous retrovirus, patient selection for clinical trials, and informed consent. It is planned to update this initial consensus statement in a year's time in light of progress in research, changes in the regulatory framework, and comments submitted after publication.