Regulation of xenogeneic porcine pancreatic islets.
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.
Arcidiacono
Judith A
JA
FDA, Center for Biologics Evaluation and Research (CBER), Office of Cellular, Tissue and Gene Therapies, Rockville, MD 20852, USA.
Evdokimov
Evgenij
E
Lee
Mark H
MH
Jones
Jeff
J
Rudenko
Larisa
L
Schneider
Bruce
B
Snoy
Phillip J
PJ
Wei
Cheng-Hong
CH
Wensky
Allen K
AK
Wonnacott
Keith
K
D000818:Animals; D030801:Animals, Genetically Modified; D002986:Clinical Trials as Topic; D017408:Guidelines as Topic; D006801:Humans; D007515:Islets of Langerhans / Q000601:surgery*; D016381:Islets of Langerhans Transplantation / Q000331:legislation & jurisprudence*; D013552:Swine; D014183:Transplantation, Heterologous / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration; D015047:Zoonoses