title: Immunosuppression and procedure-related complications in 26 patients with type 1 diabetes mellitus receiving allogeneic islet cell transplantation.
abstract: BACKGROUND
  The success of sirolimus and low-dose tacrolimus in islet cell transplantation has influenced many transplant centers to utilize this novel regimen. The long-term safety and tolerability of this steroid-free immunosuppressive protocol for allogeneic islet transplantation has yet to be determined.
  
  
  METHODS
  We transplanted 26 adult patients with long standing type 1 diabetes mellitus between April 2000 and June 2004. Immunosuppression consisted of induction with daclizumab and maintenance therapy with tacrolimus and sirolimus. Adverse events (AEs) in patients were followed and graded using the Common Terminology Criteria for Adverse Events, version 3.0 (National Cancer Institute).
  
  
  RESULTS
  To date, the majority of patients were able to remain on the immunosuppression combination for up to 22+/-11 months. Four patients were successfully converted to Mycophenolate Mofetil due to tacrolimus-related toxicity. Withdrawal from immunosuppression was decided in four patients due to hypereosinophilic syndrome, parvovirus infection, aspiration pneumonia, and severe depression, respectively. Six patients required filgrastim therapy for neutropenia. Transient elevation of liver enzymes was observed in most patients early after islet infusion. Increased LDL in 20 patients required medical treatment.
  
  
  CONCLUSIONS
  There was a varying range of AEs, most of them mild and self-limiting; however, some required urgent medical attention. The majority of patients were able to tolerate and remain on this effective regimen. To date, no deaths, cytomegalovirus disease, graft-versus-host disease, or posttransplant lymphoproliferative disease has been observed.
authors.affiliation: Diabetes Research Institute, Miller School of Medicine, University of Miami, Miami, FL 33136, USA.
authors.forename: Muhammad M
authors.initials: MM
authors.lastname: Hafiz
authors.forename: Raquel N
authors.initials: RN
authors.lastname: Faradji
authors.forename: Tatiana
authors.initials: T
authors.lastname: Froud
authors.forename: Antonello
authors.initials: A
authors.lastname: Pileggi
authors.forename: David A
authors.initials: DA
authors.lastname: Baidal
authors.forename: Pablo
authors.initials: P
authors.lastname: Cure
authors.forename: Gaston
authors.initials: G
authors.lastname: Ponte
authors.forename: Raffaella
authors.initials: R
authors.lastname: Poggioli
authors.forename: Agustin
authors.initials: A
authors.lastname: Cornejo
authors.forename: Shari
authors.initials: S
authors.lastname: Messinger
authors.forename: Camillo
authors.initials: C
authors.lastname: Ricordi
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Alejandro
mesh_terms: D000328:Adult; D002096:C-Peptide / Q000097:blood; D003922:Diabetes Mellitus, Type 1 / Q000601:surgery*; D005260:Female; D006801:Humans; D007165:Immunosuppression Therapy / Q000009:adverse effects*; D007166:Immunosuppressive Agents / Q000009:adverse effects; D016381:Islets of Langerhans Transplantation / Q000276:immunology*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000139:chemically induced*; D012189:Retrospective Studies; D014184:Transplantation, Homologous / Q000276:immunology
chemical_list: D002096:C-Peptide; D007166:Immunosuppressive Agents