A comprehensive microbiological safety approach for agarose encapsulated porcine islets intended for clinical trials.

ABSTRACT:

Background

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.

Methods

A four-checkpoint program systematically screens the donor herd (Large White - Yorkshire × Landrace F1 hybrid animals), individual sentinel and pancreas donor animals and, critically, the islet macrobeads themselves. Molecular assays screen for more

SUBMITTER: Gazda LS 

PROVIDER: S-EPMC7169751 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature