2007 Update on Allogeneic Islet Transplantation From the Collaborative Islet Transplant Registry (CITR)

As of October 1. 2007, 25 North American medical institutions and one European islet transplant center reported detailed information to the Registry on 315 allograft recipients, of which 285 were islet alone (IA) and 30 were islet after kidney (IAK). Of the 114 IA recipients expected at 4 years after their last infusion. 12% were insulin independent, 16% were insulin dependent with detectable C-peptide. 40% had no detectable C-peptide. and 32% had missing C-peptide data or were lost 10 follow-up. Of the [A recipients, 72% achieved insulin independence at least once over 3 years and Multiple infusions. Factors associated with achievement of insulin independence included islet size >10 expressed as IEQs per islet number [hazard ratio (HR) = 1.5. p = 006]. additional infusions given (HR = 1 5, p = 0.01). lower pretransplant HbA(1c), (HR = 1 2 each %-age unit. p = 0 02), donor given insulin (HR = 2. p = 0 003). daclizumab) given at any infusion (HR = 19. p = 0 06). and shorter cold storage time (HR. = 1.04, p = 0 03), mutually adjusted in a multivariate model Severe hypoglycemia prevalence was reduced from 78-83% preinfusion to less than 5% throughout the first year post-last infusion, and to 18% adjusted for missing data at 3 years post-last infusion In Year I post-first infusion for IA recipients. 53% experienced a Grade 3-5 or serious adverse event (AE) and 35% experienced a severe AE related to either an infusion procedure or immunosuppression. In Year I post-first infusion, 33% of IA subjects and 35% of IAK subjects had an AE related to the infusion procedure, while 35% of IA subjects and only 27% of IAK subjects had an AE related to the immunosuppression therapy. Five deaths were reported. of which two were classified as probably related to the infusion procedure or inimunosuppression, and 10 cases of neoplasm. of which two were classified as probably related to the procedure or immunosuppress ion. Islet transplantation continues to show short-term benefits of insulin independence, normal or near normal HbA(1c) levels. and sustained marked decrease in hypoglycemic episodes.