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U.S. Department of Health and Human Services

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Xenotransplantation 2010 Sep;17(5):329-37

Regulation of xenogeneic porcine pancreatic islets.

Arcidiacono JA, Evdokimov E, Lee MH, Jones J, Rudenko L, Schneider B, Snoy PJ, Wei CH, Wensky AK, Wonnacott K


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.

Category: Journal Article, Review
PubMed ID: #20955290 DOI: 10.1111/j.1399-3089.2010.00592.x
Includes FDA Authors from Scientific Area(s): Biologics
Entry Created: 2011-10-04 Entry Last Modified: 2012-08-29