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Safety and tolerability of the T ‐cell depletion protocol coupled with anakinra and etanercept for clinical islet cell transplantation
Author(s) -
Takita Morihito,
Matsumoto Shinichi,
Shimoda Masayuki,
Chujo Daisuke,
Itoh Takeshi,
SoRelle Jeffrey A.,
Purcell Kerri,
Onaca Nicholas,
Naziruddin Bashoo,
Levy Marlon F.
Publication year - 2012
Publication title -
clinical transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 76
eISSN - 1399-0012
pISSN - 0902-0063
DOI - 10.1111/ctr.12011
Subject(s) - medicine , transplantation , immunosuppression , type 1 diabetes , islet , population , islet cell transplantation , immunology , diabetes mellitus , pharmacology , insulin , endocrinology , environmental health
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 ( AE s) monthly. AE s were compared between three groups: first infusion with the TCD ‐ AI protocol ( TCD ‐ AI ‐1st) and first and second infusion with the E dmonton‐type protocol ( E dmonton‐1st and E dmonton‐2nd). Results The incidence of symptomatic AE s within the initial three months in the TCD ‐ AI ‐1st group was less than in the E dmonton‐1st and E dmonton‐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 E dmonton‐1st and E dmonton‐2nd groups (p < 0.05). Because of AE s, all patients in the E dmonton 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.