A comprehensive microbiological safety approach for agarose encapsulated porcine islets intended for clinical trials
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- 作者：Lawrence S. Gazda ; James Collins ; Archie Lovatt ; Robert W. Holdcraft ; Merribeth J. Morin ; Daniel Galbraith ; Melanie Graham ; Melissa A. Laramore ; Christine Maclean ; John Black ; Euan W. Milne ; Douglas G. Marthaler ; Horatiu V. Vinerean ; Michelle M. Michalak ; Deborah Hoffer ; Steven Richter ; Richard D. Hall and Barry H. Smith
- 刊名：Xenotransplantation
- 出版年：2016
- 出版时间：November/December 2016
- 年：2016
- 卷：23
- 期：6
- 页码：444-463
- 全文大小：1688K
- ISSN：1399-3089
文摘
The use of porcine islets to replace insulin-producing islet β-cells, destroyed during the diabetogenic disease process, presents distinct challenges if this option is to become a therapeutic reality for the treatment of type 1 diabetes. These challenges include a thorough evaluation of the microbiological safety of the islets. In this study, we describe a robust porcine islet-screening program that provides a high level of confidence in the microbiological safety of porcine islets suitable for clinical trials.