Document Detail


Immunosuppression and procedure-related complications in 26 patients with type 1 diabetes mellitus receiving allogeneic islet cell transplantation.
MedLine Citation:
PMID:  16378067     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Muhammad M Hafiz; Raquel N Faradji; Tatiana Froud; Antonello Pileggi; David A Baidal; Pablo Cure; Gaston Ponte; Raffaella Poggioli; Agustin Cornejo; Shari Messinger; Camillo Ricordi; Rodolfo Alejandro
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Transplantation     Volume:  80     ISSN:  0041-1337     ISO Abbreviation:  Transplantation     Publication Date:  2005 Dec 
Date Detail:
Created Date:  2005-12-26     Completed Date:  2006-01-31     Revised Date:  2007-11-14    
Medline Journal Info:
Nlm Unique ID:  0132144     Medline TA:  Transplantation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1718-28     Citation Subset:  IM    
Affiliation:
Diabetes Research Institute, Miller School of Medicine, University of Miami, Miami, FL 33136, USA.
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MeSH Terms
Descriptor/Qualifier:
Adult
C-Peptide / blood
Diabetes Mellitus, Type 1 / surgery*
Female
Humans
Immunosuppression / adverse effects*
Immunosuppressive Agents / adverse effects
Islets of Langerhans Transplantation / immunology*
Kidney Transplantation
Male
Middle Aged
Postoperative Complications / chemically induced*
Retrospective Studies
Transplantation, Homologous / immunology
Grant Support
ID/Acronym/Agency:
5 R01 DK056953/DK/NIDDK NIH HHS; 5 R01 DK55347/DK/NIDDK NIH HHS; M01RR16587/RR/NCRR NIH HHS; U42 RR016603/RR/NCRR NIH HHS
Chemical
Reg. No./Substance:
0/C-Peptide; 0/Immunosuppressive Agents

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