TABLE 2

Graft and recipient characteristics according to insulin need at 6 months posttransplantation

At posttransplant month 6
P*
Insulin independentInsulin dependent
n1515
Graft
β-Cell number (million/kg)
    First graft3.0 (2.2–4.2)2.5 (2.0–2.9)0.16
    Total4.5 (3.5–5.7)3.7 (2.6–4.7)0.11
    Cellular composition
    β-Cells32 (21–38)30 (20–37)0.87
    α-Cell9 (4–11)7 (5–10)0.34
    Nongranulated cells46 (41–63)45 (34–62)0.28
    Acinar cells1 (1–4)1 (1–5)0.80
    Dead cells8 (6–11)10 (7–12)0.31
    Two β-cell grafts891.00
    Culture time (days)6 (4–9)6 (4–10)0.66
Recipient
    Age (years)45 (41–49)40 (32–52)0.14
    Sex (male/female)10/57/80.46
    Body weight (kg)68 (64–74)68 (62–78)0.72
    BMI (kg/m2)23 (21–26)25 (22–26)0.55
    Duration of disease (years)27 (21–33)24 (17–32)0.30
    A1C (%)7.0 (6.5–7.9)7.8 (7.4–8.1)0.05
    Insulin dose (IU · kg−1 · day−1)0.52 (0.39–0.74)0.67 (0.58–0.85)0.13
    Insulin pump before transplantation14100.17
Fasting glycemia
    Mean (mg/dl)146 (129–174)166 (123–199)0.65
    CVfg (%)43 (38–46)46 (35–50)0.42
Immune status before ATG
    Total lymphocyte count1,579 (1,380–1,885)2,065 (1,869–3,005)0.007
    CD3+ count (cells/mm3)1,142 (916–1,342)1,419 (1,160–1,867)0.049
    CD19+ count (cells/mm3)247 (141–271)318 (227–514)0.023
    Leucocyte count5,300 (4,400–6,000)6,400 (5,700–8,100)0.040
    Presence of T-cell reactivity against IA2 and/or GAD6/1312/140.046
    Positivity for ICA/GAD/IA2-A4/8/62/5/70.65/0.46/1.0
    Positivity for two or more autoantibodies530.68
Immune status at first infusion
    Total lymphocyte count238 (122–313)273 (173–748)0.19
    CD3+ count (cells/mm3)24 (15–43)36 (9–83)0.73
    Leucocyte count4,700 (2,900–11,400)8,300 (3,225–12,225)0.36
Immune monitoring 0–6 months posttransplant
    Presence of T-cell reactivity against IA2 and/or GAD5/138/140.45
    Positivity for ICA/GAD/IA2-A4/8/62/7/90.65/1.0/1.0
    De novo HLA-Ab (CDC)111.0
  • Data are medians (IQR).

  • *Statistical analysis was done with Mann-Whitney U test for continues variables, Fisher exact test for dichotomous variables.

  • †These variables were confirmed as independently associated with insulin independence by multivariate analysis (binary logistic regression).