• diabetes;
  • FDA;
  • pancreatic islets;
  • porcine;
  • regulation

Arcidiacono JA, Evdokimov E, Lee MH, Jones J, Rudenko L, Schneider B, Snoy PJ, Wei C-H, Wensky AK, Wonnacott K. Regulation of xenogeneic porcine pancreatic islets. Xenotransplantation 2010; 17: 329–337. © 2010 John Wiley & Sons A/S.

Abstract:  The use of xenogeneic porcine pancreatic islets has been shown to be a potentially promising alternative to using human allogeneic islets to treat insulin-dependent type 1 diabetes (T1D). This article provides an overview of the existing FDA regulatory framework that would be applied to the regulation of clinical trials utilizing xenogeneic porcine pancreatic islets to treat T1D.