Multicenter Australian trial of islet transplantation: Improving accessibility and outcomes

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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. © Copyright 2013 The American Society of Transplantation and the American Society of Transplant Surgeons.

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O’Connell, P. J., Holmes-Walker, D. J., Goodman, D., Hawthorne, W. J., Loudovaris, T., Gunton, J. E., … Kay, T. W. (2013). Multicenter Australian trial of islet transplantation: Improving accessibility and outcomes. American Journal of Transplantation, 13(7), 1850–1858. https://doi.org/10.1111/ajt.12250

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