MEDtube Science 2014 - Clinical estimate of endotoxin levels in human islet cell suspensions destined for transplantation

Microbiological purity of isolated islet cell suspensions destined for transplant is one of the basic conditions, which determine both function of the transplanted graft and recipient survival. Prior to islet cell transplantation, it is necessary to confirm the lack of microorganisms and to ensure that the endotoxin levels do not exceed acceptable values. The goal of this study was to determine the microbiological purity of isolated islet cell suspensions acquired from pancreases using the PTS (Portable Test System) test. Material and methods. Study was conducted on islets suspension prepared for transplantation between 2011 and 2013 in the Department of General and Transplantation Surgery, Warsaw Medical University. The presence of microorganisms were determined in the transport solution (first product). In the end product microorganisms and endotoxin levels (PTs samtest) prepared for transplant (final product) were analysed. Results. Studies show that using GMP collagenase during isolation and purification of islet cell suspension on cell separator produces an endotoxin value of an acceptable level (below 5 EU/kg recipient’s body mass). Conclusion. Taking into account the time of testing and the costs associated with the transplantation procedure, the PTS test is a quick and reliable method to determine endotoxin levels in isolated islet cell suspensions destined for transplant.