Literature DB >> 15289639

FDA regulation of allogeneic islets as a biological product.

Darin J Weber1.   

Abstract

This article describes the Food and Drug Administration's recent manufacturing review experience with investigational new drug applications submitted for allogeneic pancreatic islets of Langerhans for the treatment of type 1 diabetes mellitus. In addition, considerations of islet preparation issues that will need to be resolved before the submission of a biologics license application are discussed.

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Year:  2004        PMID： 15289639     DOI： 10.1385/cbb:40:3:19

Source DB:  PubMed          Journal:  Cell Biochem Biophys        ISSN： 1085-9195            Impact factor:   2.194


  9 in total

1.  Report from IPITA-TTS Opinion Leaders Meeting on the Future of β-Cell Replacement.

Authors:  Stephen T Bartlett; James F Markmann; Paul Johnson; Olle Korsgren; Bernhard J Hering; David Scharp; Thomas W H Kay; Jonathan Bromberg; Jon S Odorico; Gordon C Weir; Nancy Bridges; Raja Kandaswamy; Peter Stock; Peter Friend; Mitsukazu Gotoh; David K C Cooper; Chung-Gyu Park; Phillip OʼConnell; Cherie Stabler; Shinichi Matsumoto; Barbara Ludwig; Pratik Choudhary; Boris Kovatchev; Michael R Rickels; Megan Sykes; Kathryn Wood; Kristy Kraemer; Albert Hwa; Edward Stanley; Camillo Ricordi; Mark Zimmerman; Julia Greenstein; Eduard Montanya; Timo Otonkoski
Journal:  Transplantation       Date:  2016-02       Impact factor: 4.939

Review 2.  Islet transplantation: current status and future directions.

Authors:  Betul Hatipoglu; Enrico Benedetti; José Oberholzer
Journal:  Curr Diab Rep       Date:  2005-08       Impact factor: 4.810

3.  Detailed protocol for evaluation of dynamic perifusion of human islets to assess β-cell function.

Authors:  Kwamina Bentsi-Barnes; Máire E Doyle; Danny Abad; Fouad Kandeel; Ismail Al-Abdullah
Journal:  Islets       Date:  2011-09-01       Impact factor: 2.694

4.  The Choice of Enzyme for Human Pancreas Digestion is a Critical Factor for Increasing the Success of Islet Isolation.

Authors:  Meirigeng Qi; Luis Valiente; Brian McFadden; Keiko Omori; Shiela Bilbao; Jemily Juan; Jeffrey Rawson; Stephen Scott; Kevin Ferreri; Yoko Mullen; Mohamed El-Shahawy; Donald Dafoe; Fouad Kandeel; Ismail H Al-Abdullah
Journal:  Transplant Direct       Date:  2015-05

5.  Quantitative assessment of islets of Langerhans encapsulated in alginate.

Authors:  Amy S Johnson; Esther O'Sullivan; Laura N D'Aoust; Abdulkadir Omer; Susan Bonner-Weir; Robert J Fisher; Gordon C Weir; Clark K Colton
Journal:  Tissue Eng Part C Methods       Date:  2011-01-16       Impact factor: 3.056

Review 6.  Engineering islets from stem cells for advanced therapies of diabetes.

Authors:  Johanna Siehler; Anna Karolina Blöchinger; Matthias Meier; Heiko Lickert
Journal:  Nat Rev Drug Discov       Date:  2021-08-10       Impact factor: 84.694

7.  Multicenter analysis of novel and established variables associated with successful human islet isolation outcomes.

Authors:  J S Kaddis; J S Danobeitia; J C Niland; T Stiller; L A Fernandez
Journal:  Am J Transplant       Date:  2010-01-05       Impact factor: 8.086

Review 8.  Islet assessment for transplantation.

Authors:  Klearchos K Papas; Thomas M Suszynski; Clark K Colton
Journal:  Curr Opin Organ Transplant       Date:  2009-12       Impact factor: 2.640

9.  Prophylactically Decontaminating Human Islet Product for Safe Clinical Application: Effective and Potent Method.

Authors:  Meirigeng Qi; Keiko Omori; Yoko Mullen; Brian McFadden; Luis Valiente; Jemily Juan; Shiela Bilbao; Bernard R Tegtmeier; Donald Dafoe; Fouad Kandeel; Ismail H Al-Abdullah
Journal:  Transplant Direct       Date:  2016-02
  9 in total

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