| Regulation of xenogeneic porcine pancreatic islets. | |
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MedLine Citation:
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PMID: 20955290 Owner: NLM Status: In-Process |
Abstract/OtherAbstract:
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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. |
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Authors:
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Judith A Arcidiacono; Evgenij Evdokimov; Mark H Lee; Jeff Jones; Larisa Rudenko; Bruce Schneider; Phillip J Snoy; Cheng-Hong Wei; Allen K Wensky; Keith Wonnacott |
Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Xenotransplantation Volume: 17 ISSN: 1399-3089 ISO Abbreviation: Xenotransplantation Publication Date: 2010 Sep-Oct |
Date Detail:
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Created Date: 2010-10-19 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9438793 Medline TA: Xenotransplantation Country: Denmark |
Other Details:
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Languages: eng Pagination: 329-37 Citation Subset: IM |
Copyright Information:
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© 2010 John Wiley & Sons A/S. |
Affiliation:
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FDA, Center for Biologics Evaluation and Research (CBER), Office of Cellular, Tissue and Gene Therapies, Rockville, MD 20852, USA. |
Export Citation:
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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