Literature DB >> 12499908

Selected Food and Drug Administration review issues for regulation of allogeneic islets of langerhans as somatic cell therapy.

Darin J Weber1, Richard D McFarland, Ilan Irony.   

Abstract

The Food and Drug Administration has seen a significant increase in investigational new drug (IND) applications for the use of allogeneic islets of Langerhans to treat type 1 diabetes mellitus. The current regulatory framework for clinical use of allogeneic islets of Langerhans is described. In addition, expectations and considerations for information to be included in the manufacturing, preclinical, and clinical sections of an IND for allogeneic islets of Langerhans to treat type 1 diabetes mellitus are discussed.

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Year:  2002        PMID： 12499908     DOI： 10.1097/00007890-200212270-00034

Source DB:  PubMed          Journal:  Transplantation        ISSN： 0041-1337            Impact factor:   4.939


  9 in total

Review 1.  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

2.  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

3.  Prediction of marginal mass required for successful islet transplantation.

Authors:  Klearchos K Papas; Clark K Colton; Andi Qipo; Haiyan Wu; Rebecca A Nelson; Bernhard J Hering; Gordon C Weir; Maria Koulmanda
Journal:  J Invest Surg       Date:  2010-02       Impact factor: 2.533

4.  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

5.  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

6.  A stirred microchamber for oxygen consumption rate measurements with pancreatic islets.

Authors:  Klearchos K Papas; Anna Pisania; Haiyan Wu; Gordon C Weir; Clark K Colton
Journal:  Biotechnol Bioeng       Date:  2007-12-01       Impact factor: 4.530

7.  Regulatory challenges in manufacturing of pancreatic islets.

Authors:  E Linetsky; C Ricordi
Journal:  Transplant Proc       Date:  2008-03       Impact factor: 1.066

8.  Enumeration of islets by nuclei counting and light microscopic analysis.

Authors:  Anna Pisania; Klearchos K Papas; Daryl E Powers; Michael J Rappel; Abdulkadir Omer; Susan Bonner-Weir; Gordon C Weir; Clark K Colton
Journal:  Lab Invest       Date:  2010-08-09       Impact factor: 5.662

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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