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Immunology and Transplantation

Five-Year Follow-Up After Clinical Islet Transplantation

  1. Edmond A. Ryan1,
  2. Breay W. Paty1,
  3. Peter A. Senior1,
  4. David Bigam2,
  5. Eman Alfadhli1,
  6. Norman M. Kneteman2,
  7. Jonathan R.T. Lakey2 and
  8. A.M. James Shapiro2
  1. 1Department of Medicine, Clinical Islet Transplant Program, University of Alberta and Capital Health, Edmonton, Alberta, Canada
  2. 2Department of Surgery, Clinical Islet Transplant Program, University of Alberta and Capital Health, Edmonton, Alberta, Canada
  1. Address correspondence and reprint requests to Edmond A. Ryan, Clinical Islet Transplant Program, 2000 College Plaza, 8215 112th St., Edmonton, Alberta, Canada T6G 2C8. E-mail: edmond.ryan{at}ualberta.ca
Diabetes 2005 Jul; 54(7): 2060-2069. https://doi.org/10.2337/diabetes.54.7.2060
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  • FIG. 1.
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    FIG. 1.

    A: Exogenous insulin use in relation to the number of islets transplanted. Shown are pretransplant (•), after the first transplant (○), after the second transplant (▾), or after the third transplant (▿). Insulin requirements dropped after the first transplant, and many became insulin independent after the second transplant. Three patients still required exogenous insulin after three transplants. B: The amount of exogenous insulin required 1 month after the first transplant (Tx) expressed as a percentage of the pretransplant insulin requirement. Shown are the groups of patients who became insulin independent after the second transplant (•) and those who did not achieve insulin independence after two transplants (○). If the insulin requirements did not fall by 50% or more, it was unlikely that the subject would become insulin independent with one further transplant.

  • FIG. 2.
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    FIG. 2.

    A: Survival analysis for C-peptide secretion over time for all those who completed the islet transplant procedures. The curves are dated from the time of the final transplant. Graft function was well maintained with 82% graft survival at 5 years. B: Survival analysis for insulin independence over time for all those who completed the islet transplant procedures. The majority of patients needed to resume insulin therapy with 7.5% insulin independence at 5 years. C: Survival analysis for insulin independence over time for all those who completed the islet transplant procedures depending on whether they required only one (- - -▵- - -) (n = 5 initally and n = 3 for final timepoint), two (—▪—) (n = 33 initally and n = 3 for final timepoint), or three (—○—) (n = 9 initally and n = 4 for final timepoint) transplant procedures.

  • FIG. 3.
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    FIG. 3.

    The HbA1c, mean ± SE, over time posttransplantation in those whose transplant failed (—•—), those whose graft remained functioning but had to resume insulin (—○—), and those who remained insulin independent (—♦——). Loss of graft function was associated with an increase of the HbA1c. The group off insulin was significantly different from the others. Tx, transplant.

  • FIG. 4.
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    FIG. 4.

    Plasma glucose (A) and C-peptide (B) values, mean ± SE, before (—•—) and 90 min after (—○—) consuming a standard meal in those subjects who remained off insulin. The number of subjects studied were 36 pretransplant, 28 at 1 year, 12 at 2 years, 7 at 3 years, and 1 at 4 years. All values posttransplant were significantly different from the pretransplant values. Also shown are the plasma glucose (A) and C-peptide values (B), mean ± SE, before (- - -♦- - -) and 90 min after (- - -⋄- - -) consuming a standard meal in those subjects who resumed insulin therapy. The number of subjects studied were 36 pretransplant, 12 at 1 year, 13 at 2 years, 12 at 3 years, 5 at 4 years, and 2 at 5 years. All values posttransplant were significantly different from the pretransplant values. Tx, transplant.

  • FIG. 5.
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    FIG. 5.

    The HYPO score (A) and LI (B) pre- and posttransplant in those who remained C-peptide positive. The box plots show the 25th–75th IQ range, and the bars show the 10th–90th IQ range. The controls have been described previously (9). For the HYPO score pretransplant, n = 31; at 1 year, n = 40; at 2 years, n = 29; at 3 years, n = 15; at 4 years, n = 7; and at 5 years, n = 5. For the LI pretransplant, n = 42; at 1 year, n = 41; at 2 years, n = 28; at 3 years, n = 15; at 4 years, n = 7; and at 5 years, n = 5. Posttransplant the scores for years 1–4 are significantly better than the pretransplant values. Tx, transplant.

Tables

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  • TABLE 1

    Positive antibodies and the β-score

    nβ-score
    Allo-
        % PRA range
            0–9426.0 (5.0–7.0)
            10–3973.0 (1.0–5.5)*
            ≥4072.0 (0.0–4.0)*
    Auto-
        Antibody status (either pre- or posttransplant)
            GAD or ICA both negative265.0 (3.0–6.0)
            Either GAD or ICA positive226.0 (4.0–7.0)
            Both GAD and ICA positive93.0 (2.0–7.0)
    • Data are median (IQ range). PRA was measured to both class 1 and 2 antigens. Allo: the β-score and %PRA were determined 1 year after the initial transplant.

    • *

      * The difference in the β-score for the PRA groups was significantly different from the 0–9% group, P < 0.05. Auto: autoantibodies and the β-score were determined at 1 year, and values among the antibody status groups were similar. ICA, islet cell antibody.

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Five-Year Follow-Up After Clinical Islet Transplantation
Edmond A. Ryan, Breay W. Paty, Peter A. Senior, David Bigam, Eman Alfadhli, Norman M. Kneteman, Jonathan R.T. Lakey, A.M. James Shapiro
Diabetes Jul 2005, 54 (7) 2060-2069; DOI: 10.2337/diabetes.54.7.2060

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Five-Year Follow-Up After Clinical Islet Transplantation
Edmond A. Ryan, Breay W. Paty, Peter A. Senior, David Bigam, Eman Alfadhli, Norman M. Kneteman, Jonathan R.T. Lakey, A.M. James Shapiro
Diabetes Jul 2005, 54 (7) 2060-2069; DOI: 10.2337/diabetes.54.7.2060
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