2007 Update on Allogeneic Islet Transplantation from the Collaborative Islet Transplant Registry (CITR). Cell transplantation [Cell Transplant] Journal article

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. Of the 114 IA recipients expected at four 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 to follow-up. Of the IA recipients, 72% achieved insulin independence at least once over three years and multiple infusions. Factors associated with achievement of insulin independence included islet size >1.0 expressed as IEQs per islet number (hazard ratio, HR=1.5 p=0.06), additional infusions given (HR=1.5, p=0.01), lower pre-transplant HbA1c (HR=1.2 each %-age unit, p=0.02), donor given insulin (HR=2, p=0.003), daclizumab given at any infusion (HR=1.9, p=0.06), and shorter cold storage time (HR=1.04, p=0.03), mutually adjusted in a multivariate model. Severe hypoglycemia prevalence is reduced from 78-83% pre-infusion to less than 5% throughout the first year post-last infusion, and to 18% adjusted for missing data at three years post-last infusion. In Year 1 post-first infusion for islet alone recipients, 53% of IA recipients 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 1 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 immunosuppression, and ten cases of neoplasm, of which two were classified as probably related to the procedure or immunosuppression. Islet transplantation continues to show short-term benefits of insulin independence, normal or near normal HbAC levels, and sustained marked decrease in hypoglycemic episodes.

Cell transplantation [Cell Transplant]