The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes-Chapter 4: Pre-clinical efficacy and complication data required to justify a clinical trial

David K C Cooper, Anna Casu

Research output: Contribution to journalArticle

Abstract

Pre-clinical efficacy and complication data required to justify a porcine islet transplantation clinical trial have been considered. To be relevant to clinical islet transplantation, pre-clinical data should be obtained in a pig-to-diabetic non-human primate (NHP) model. In view of the difficulties of maintaining immunosuppressed NHPs for long periods of time, flexibility must be allowed with regard to the following recommendations. A pre-clinical trial would be deemed a success if five of eight consecutive experiments in NHPs with proven diabetes meet the following guidelines. 1. The fasting and non-fasting blood glucose levels have been maintained in the NHP at approximately 8.3 mmol/l) and

Original languageEnglish
Pages (from-to)229-238
Number of pages10
JournalXenotransplantation
Volume16
Issue number4
DOIs
Publication statusPublished - Jul 2009

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Islets of Langerhans Transplantation
Heterologous Transplantation
Type 1 Diabetes Mellitus
Primates
Consensus
Swine
Clinical Trials
Blood Glucose
Fasting
Guidelines

Keywords

  • Islets of Langerhans
  • Pre-clinical animal models
  • Type 1 diabetes
  • Xenotransplantation

ASJC Scopus subject areas

  • Transplantation
  • Immunology

Cite this

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