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Comparative Study
. 2010 Sep;10(9):2082-91.
doi: 10.1111/j.1600-6143.2010.03212.x.

Experience with a novel efalizumab-based immunosuppressive regimen to facilitate single donor islet cell transplantation

N A Turgeon  1 , J G Avila, J A Cano, J J Hutchinson, I R Badell, A J Page, A B Adams, M H Sears, P H Bowen, A D Kirk, T C Pearson, C P Larsen
Affiliations
Comparative Study

Experience with a novel efalizumab-based immunosuppressive regimen to facilitate single donor islet cell transplantation

N A Turgeon et al. Am J Transplant. 2010 Sep.

Abstract

Islet transplantation is an experimental therapy for selected patients with type 1 diabetes (T1DM). It remains limited by immunosuppressive drug toxicity, progressive loss of insulin independence, allosensitization and the need for multiple islet donors. We describe our experience with an efalizumab-based immunosuppressive regimen as compared to the prevailing standard regimen, the Edmonton protocol. Twelve patients with T1DM received islet transplants: eight were treated with the Edmonton protocol; four were treated with daclizumab induction, a 6-month course of tacrolimus, and maintenance with efalizumab and mycophenolate mofetil. The primary endpoint was insulin independence after one islet infusion. Only two Edmonton protocol treated patients achieved the primary endpoint; six required islets from multiple donors, and all experienced leukopenia, mouth ulcers, anemia, diarrhea and hypertransaminasemia. Four became allosensitized. All patients treated with the efalizumab-based regimen achieved insulin independence with normal hemoglobin A1c after a single islet cell infusion and remained insulin independent while on efalizumab. These patients experienced significantly fewer side effects and none became allosensitized. Trial continuation was terminated by withdrawal of efalizumab from the market. These data suggest that this efalizumab-based regimen prevents islet rejection, is well tolerated, and allows for single donor islet transplantation.

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Figures

Figure 1
Figure 1
Stimulated c-peptide (blue), fasting c-peptide (red), and HbA1c (green) in all patients treated in this study.
Figure 2
Figure 2
Insulin levels in all patients treated in this study. Arrows indicate times at which Group 2 patients were discontinued from efalizumab and converted to abatacept (patients 2–4) or voluntarily withdrew from immunosuppression (Subject 1).
Figure 3
Figure 3
Serum creatinine levels and calculated GFR using MDRD calculation in all patients treated in this study.
See this image and copyright information in PMC

Comment in

References

    1. Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047–1053. - PubMed
    1. Hypoglycemia in the Diabetes Control and Complications Trial. The Diabetes Control and Complications Trial Research Group. Diabetes. 1997 Feb;46(2):271–286. 1997. - PubMed
    1. Jacqueminet S, Masseboeuf N, Rolland M, Grimaldi A, Sachon C. Limitations of the so-called "intensified" insulin therapy in type 1 diabetes mellitus. Diabetes Metab. 2005 Sep;31(4 Pt 2):4S45–4S50. - PubMed
    1. Shapiro AM, Lakey JR, Ryan EA, Korbutt GS, Toth E, Warnock GL, et al. Islet transplantation in seven patients with type 1 diabetes mellitus using a glucocorticoid-free immunosuppressive regimen. N Engl J Med. 2000 Jul 27;343(4):230–238. - PubMed
    1. Shapiro AM, Ricordi C, Hering BJ, Auchincloss H, Lindblad R, Robertson RP, et al. International trial of the Edmonton protocol for islet transplantation. N Engl J Med. 2006 Sep 28;355(13):1318–1330. - PubMed

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