Multicenter Australian Trial of Islet Transplantation: Improving Accessibility and Outcomes |
| |
| Authors: | 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 On behalf of the Australian Islet Transplant Consortium |
| |
| Institution: | 1. National Pancreas Transplant Unit, University of Sydney at Westmead Hospital, , Australia;2. Department of Endocrinology, University of Sydney at Westmead Hospital, , Australia;3. Department of Medicine, St. Vincent's Hospital Melbourne University of Melbourne, , Australia;4. Department of Nephrology, St Vincent's Hospital Melbourne, , Victoria, Australia;5. St Vincent's Institute, , Victoria, Australia;6. Garvan Institute of Medical Research, University of New South Wales, , Australia;7. Central Northern Adelaide Renal and Transplantation Service, Royal Adelaide Hospital, , Australia;8. Departments of Nephrology Endocrinology and Diabetes, St Vincent's Hospital Melbourne, , Victoria, Australia |
| |
| 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. |
| |
| Keywords: | Antithymocyte globulin (ATG) diabetes graft function hypoglycemia insulin insulin independence islets sirolimus tacrolimus transplantation |
|
|
