Immunosuppression and procedure-related complications in 26 patients with type 1 diabetes mellitus receiving allogeneic islet cell transplantation.

Transplantation 2005 Dec;80(12):1718-28

Diabetes Research Institute, Miller School of Medicine, University of Miami, Miami, FL 33136, USA.

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.

Conclusion: 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.

Download full-text PDF

Source
http://dx.doi.org/10.1097/01.tp.0000187881.97068.77DOI Listing
December 2005
11 Reads

Publication Analysis

Top Keywords

patients
10
allogeneic islet
8
diabetes mellitus
8
islet cell
8
patients required
8
cell transplantation
8
type diabetes
8
majority patients
8
adverse events
8
toxicity withdrawal
4
withdrawal immunosuppression
4
immunosuppression decided
4
tacrolimus-related toxicity
4
mofetil tacrolimus-related
4
patients converted
4
converted mycophenolate
4
mycophenolate mofetil
4
decided patients
4
patients hypereosinophilic
4
aspiration pneumonia
4

Similar Publications