24 – Tests for Validating the Safety of Encapsulated Xenografts

Publisher Summary This chapter describes tests for validating the safety of encapsulated xenografts. Xenografts are the most demanding form of cellular transplants because they directly confront the host immune system. At the same time, there are clear advantages to working with cells from a well-characterized xenogeneic source, provided some method of immunoisolation or host immune modulation is available. Selecting a source of cells for a transplant study depends on the intended function of those cells. When clinical transplant strategies restrict cells to allogeneic sources, shortages can be expected. This chapter provides suggestions for validating reproducible and safe devices for therapeutic applications of xenogeneic cells in polymer-encapsulated transplant studies. Tests to validate the safety and reproducibility of encapsulated xenografts include evaluations of the device, cells, and host response. The tests discussed in this chapter are generally available to most researchers. The encapsulated chromaffin cell-loaded devices are currently under clinical evaluation in Switzerland for the management of intractable pain in terminal cancer patients.