The aim of the study was to assess long-term outcomes of the pancreatic islet transplantation. Methods: Human pancreatic islets were administered sequentially in up to 3 separate infusions with the goal of insulin independence. The immunosuppression protocol consisted of IL-2R antibody, rapamycin and tacrolimus. Results: After intensive screening of over 900 patients, only 9 (5.5%) were selected from 163 evaluated as suitable candidates. The main reasons for exclusions were BMI>28 (24%), need for optimization of insulin therapy (20%), self exclusion (15%), and CrCl<80 (14%). Four out of 9 (44%) patients completed the islet transplant protocol. All four patients are currently insulin-free 92, 73, 70, and 59 months after first infusion of total 19+/- 2 kIEQ/kg islet mass. Mean age and BMI was 46+/-3 and 20+/-1, respectively. In this cohort of patients, glycemic control improved dramatically, with elimination of hypoglycemic unawareness, lowering of HbA1C (8.4+/-0.7 to 5.9) and MAGE (5.5+-1.1 to 1.7+-0.3). Additionally, Beta score rose from 1, 1,3, 0 to 8, 8, 8, 7, respectively. None of these patients developed a positive PRA despite multiple islet infusions (up to 3). Rapamicin had to be replaced with antimetabolites in 3 individuals and tacrolimus in remaining one due to complications. None of patient developed proteinuria and average MDRD GFR did not change significantly. All patients did require statins and antihypertensive medications. There was also a large improvement in QoL. Five remaining patients did not complete the transplant protocol. They dropped the study or they were withdrawn after the first infusion secondary to noncompliance, narcotic and alcohol abuse, and/or disappointment with the initial results. Conclusion: Only a small fraction of candidates are suitable for islet transplantation. Careful selection is vital in order to limit high drop out rates. Immunosuppressant medications must be frequently adjusted to facilitate islet survival and long-term health of the recipients. At our institution, pancreatic islet transplantation offered durable long-term insulin free glycemic control in highly selected brittle diabetics without increased risk for sensitization.

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