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- Title
Regulation of xenogeneic porcine pancreatic islets.
- Authors
Arcidiacono, Judith A.; Evdokimov, Evgenij; Lee, Mark H.; Jones, Jeff; Rudenko, Larisa; Schneider, Bruce; Snoy, Phillip J.; Cheng-Hong Wei; Wensky, Allen K.; Wonnacott, Keith
- Abstract
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. 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.
- Subjects
PORCINE reproductive &; respiratory syndrome; VIRUS diseases in swine; ISLANDS of Langerhans; PANCREATIC diseases; CLINICAL medicine; CLINICAL trials
- Publication
Xenotransplantation, 2010, Vol 17, Issue 5, p329
- ISSN
0908-665X
- Publication type
Article
- DOI
10.1111/j.1399-3089.2010.00592.x