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

Muhammad M. Hafiz, Raquel N. Faradji, Tatiana Froud, Antonello Pileggi, David Baidal, Pablo Cure, Gaston Ponte, Raffaella Poggioli, Agustin Cornejo, Shari Messinger, Camillo Ricordi, Rodolfo Alejandro

Research output: Contribution to journalArticle

72 Citations (Scopus)

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. 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.

Original languageEnglish
Pages (from-to)1718-1728
Number of pages11
JournalTransplantation
Volume80
Issue number12
DOIs
StatePublished - Dec 1 2005

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Islets of Langerhans Transplantation
Cell Transplantation
Homologous Transplantation
Type 1 Diabetes Mellitus
Islets of Langerhans
Immunosuppression
Tacrolimus
Sirolimus
Hypereosinophilic Syndrome
Mycophenolic Acid
Parvoviridae Infections
Aspiration Pneumonia
National Cancer Institute (U.S.)
Graft vs Host Disease
Immunosuppressive Agents
Neutropenia
Cytomegalovirus
Terminology
Therapeutics
Steroids

Keywords

  • Adverse events
  • Complications
  • Islet transplantation

ASJC Scopus subject areas

  • Transplantation
  • Immunology

Cite this

Immunosuppression and procedure-related complications in 26 patients with type 1 diabetes mellitus receiving allogeneic islet cell transplantation. / Hafiz, Muhammad M.; Faradji, Raquel N.; Froud, Tatiana; Pileggi, Antonello; Baidal, David; Cure, Pablo; Ponte, Gaston; Poggioli, Raffaella; Cornejo, Agustin; Messinger, Shari; Ricordi, Camillo; Alejandro, Rodolfo.

In: Transplantation, Vol. 80, No. 12, 01.12.2005, p. 1718-1728.

Research output: Contribution to journalArticle

Hafiz, Muhammad M. ; Faradji, Raquel N. ; Froud, Tatiana ; Pileggi, Antonello ; Baidal, David ; Cure, Pablo ; Ponte, Gaston ; Poggioli, Raffaella ; Cornejo, Agustin ; Messinger, Shari ; Ricordi, Camillo ; Alejandro, Rodolfo. / Immunosuppression and procedure-related complications in 26 patients with type 1 diabetes mellitus receiving allogeneic islet cell transplantation. In: Transplantation. 2005 ; Vol. 80, No. 12. pp. 1718-1728.
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AU - Cure, Pablo

AU - Ponte, Gaston

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AU - Ricordi, Camillo

AU - Alejandro, Rodolfo

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