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.
FDA, Center for Biologics Evaluation and Research (CBER), Office of Cellular, Tissue and Gene Therapies, Rockville, MD 20852, USA.
Judith A
JA
Arcidiacono
Evgenij
E
Evdokimov
Mark H
MH
Lee
Jeff
J
Jones
Larisa
L
Rudenko
Bruce
B
Schneider
Phillip J
PJ
Snoy
Cheng-Hong
CH
Wei
Allen K
AK
Wensky
Keith
K
Wonnacott
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