Multicenter Australian trial of islet transplantation: Improving accessibility and outcomes

P. J. O'Connell, D. J. Holmes-Walker, D. Goodman, W. J. Hawthorne, T. Loudovaris, J. E. Gunton, H. E. Thomas, S. T. Grey, C. J. Drogemuller, G. M. Ward, D. J. Torpy, P. T. Coates, T. W. Kay

Research output: Contribution to journalArticlepeer-review

85 Scopus citations

Abstract

Whilst initial rates of insulin independence following islet transplantation are encouraging, long-term function using the Edmonton Protocol remains a concern. The aim of this single-arm, multicenter study was to evaluate an immunosuppressive protocol of initial antithymocyte globulin (ATG), tacrolimus and mycophenolate mofetil (MMF) followed by switching to sirolimus and MMF. Islets were cultured for 24 h prior to transplantation. The primary end-point was an HbA1c of <7% and cessation of severe hypoglycemia. Seventeen recipients were followed for ≥12 months. Nine islet preparations were transported interstate for transplantation. Similar outcomes were achieved at all three centers. Fourteen of the 17 (82%) recipients achieved the primary end-point. Nine (53%) recipients achieved insulin independence for a median of 26 months (range 7-39 months) and 6 (35%) remain insulin independent. All recipients were C-peptide positive for at least 3 months. All subjects with unstimulated C-peptide >0.2 nmol/L had cessation of severe hypoglycemia. Nine of the 17 recipients tolerated switching from tacrolimus to sirolimus with similar graft outcomes. There was a small but significant reduction in renal function in the first 12 months. The combination of islet culture, ATG, tacrolimus and MMF is a viable alternative for islet transplantation.

Original languageEnglish (US)
Pages (from-to)1850-1858
Number of pages9
JournalAmerican Journal of Transplantation
Volume13
Issue number7
DOIs
StatePublished - Jul 2013
Externally publishedYes

Keywords

  • Antithymocyte globulin (ATG)
  • diabetes
  • graft function
  • hypoglycemia
  • insulin
  • insulin independence
  • islets
  • sirolimus
  • tacrolimus
  • transplantation

ASJC Scopus subject areas

  • Immunology and Allergy
  • Transplantation
  • Pharmacology (medical)

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