Safety and tolerability of the T-cell depletion protocol coupled with anakinra and etanercept for clinical islet cell transplantation

Morihito Takita, Shinichi Matsumoto, Masayuki Shimoda, Daisuke Chujo, Takeshi Itoh, Jeffrey A. Sorelle, Kerri Purcell, Nicholas Onaca, Bashoo Naziruddin, Marlon F. Levy

Research output: Contribution to journalArticlepeer-review

30 Scopus citations


Background: Islet cell transplantation (ICT) is a promising approach to cure patients with type 1 diabetes. We have implemented a new immunosuppression protocol with antithymoglobulin plus anti-inflammatory agents of anakinra and eternacept for induction and tacrolimus plus mycophenolate mofetil for maintenance [T-cell depletion with anti-inflammatory (TCD-AI) protocol], resulting in successful single-donor ICT. Methods: Eight islet recipients with type 1 diabetes reported adverse events (AEs) monthly. AEs were compared between three groups: first infusion with the TCD-AI protocol (TCD-AI-1st) and first and second infusion with the Edmonton-type protocol (Edmonton-1st and Edmonton-2nd). Results: The incidence of symptomatic AEs within the initial three months in the TCD-AI-1st group was less than in the Edmonton-1st and Edmonton-2nd groups, with a marginally significant difference (mean ± SE: 5.5 ± 0.3, 7.5 ± 0.5, and 8.3 ± 1.3, respectively; p = 0.07). A significant reduction in liver enzyme elevation after ICT was found in the TCD-AI-1st group compared with the Edmonton-1st and Edmonton-2nd groups (p < 0.05). Because of AEs, all patients in the Edmonton protocol eventually converted to the TCD-AI protocol, whereas all patients tolerated the TCD-AI protocol. Conclusions: TCD-AI protocol can be tolerated for successful ICT, although this study includes small cohort, and large population trial should be taken.

Original languageEnglish (US)
Pages (from-to)E471-E484
JournalClinical Transplantation
Issue number5
StatePublished - Sep 2012
Externally publishedYes


  • Adverse event
  • Anti-inflammatory agents
  • Antithymocyte globulin
  • Sirolimus
  • Type 1 diabetes

ASJC Scopus subject areas

  • Transplantation


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