Setting Up a Haplobank: Issues and Solutions.
Setting Up a Haplobank: Issues and Solutions.
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DOI：
10.1007/s40778-015-0011-7
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发表时间：
2015
影响因子：
1.4
通讯作者：
Turner M
中科院分区：
文献类型：
--
作者：
Barry J;Hyllner J;Stacey G;Taylor CJ;Turner M
诱导多能干细胞的发展为再生医学细胞疗法的规模化生产提供了可能。此外，可以根据主要的移植抗原系统选择捐赠者，以匹配全球尽可能多的接受者，从而降低免疫排斥的可能风险和所需的免疫抑制或耐受程度。如果要广泛使用这种细胞系，就需要在不同司法管辖区对共同标准进行相互承认。将需要围绕以下问题进行广泛的国际合作：确定最佳纯合子人类白细胞抗原(HLA)小组、捐赠者选择、筛查和同意、良好的制造规范(GMP)、标准和质量控制以及监管立法。建立一个全球GMP诱导的多能干细胞(IPSC)单库的挑战是巨大的。我们认为，现在是时候尝试在GMP IPSC制造的共同标准周围达成国际协议，以免该领域以支离破碎的方式发展。
The development of induced pluripotent stem cells offers the possibility of the scalable manufacture of cellular therapies for regenerative medicine. Moreover, donors can be selected on the basis of major transplant antigen systems to match the widest possible number of recipients worldwide, reducing the likely risk of immunological rejection and the degree of immune suppression or tolerance required. If such cell lines are to be broadly available, there will need to be mutual recognition of common standards across different jurisdictions. Extensive international collaboration will be required around issues such as determination of the optimal homozygous human leukocyte antigens (HLA) panel, donor selection, screening and consent, good manufacturing practice (GMP), standards and quality control and regulatory legislation. The challenges in establishing a global GMP induced pluripotent stem cell (iPSC) haplobank are formidable. We argue that now is the time to attempt to reach international agreement around common standards for GMP iPSC manufacture before the field develops in a fragmented manner.