Table 1

Baseline and postinfusion characteristics of autologous UCB recipients

PreinfusionPostinfusion(Preinfusion–to–1 year ratio) − 1(Preinfusion–to–2 year ratio) − 1
3 months6 months9 months1 year1.5 years2 years
HbA1c (%)7.4 (6.5–8.4) {24}7.5 (7.1–8.5) {24} [NS]7.5 (7.1–8.5) {23} [NS]7.1 (6.7–7.1) {23} [NS]7.1 (6.7–7.8) {24} [NS]7.1 (6.6–7.9) {20} [NS}7.6 (7.2–8.0) {21} [NS]−0.2 (−0.6 to 0.7) {24} [NS]0.1 (−0.5 to 0.9) {21} [NS]
Insulin use (units/kg per day)0.37 (0.22–0.51) {24}0.46 (0.28–0.58) {23} [NS]0.58 (0.44–0.79) {23} [NS]0.58 (0.44–0.79) {23} [NS]0.69 (0.55–0.81) {23} [<0.001]0.63 (0.57–0.77) {20} [0.001]0.66 (0.61–0.81) {21} [<0.001]−0.22 (−0.53 to −0.085) {20} [<0.001]−0.44 (−0.68 to −0.21) {21} [<0.001]
Peak C-peptide (ng/mL)1.16 (0.7–1.71) {22}0.83 (0.24–1.28) {24} [0.006]0.73 (0.47–1.35) {23} [0.003]0.6 (0.08–1.36) {20} [<0.001]0.28 (0.16–0.86) {21} [<0.001]0.17 (0–0.95) {19} [<0.001]0.05 (0–0.58) {21} [<0.001]−0.53 (−1.0 to −0.16) {20} [<0.001]−0.7 (−1.4 to −0.5) {19} [<0.001]
AUC C-peptide (ng/mL)0.95 (0.51–1.4) {22}0.66 (0.2–1.0) {24} [0.002]0.64 (0.2–1.1) {23} [<0.001]0.46 (0.03–1.1) {20} [<0.001]0.22 (0.02–0.63) {21} [<0.001]0.15 (0–0.7) {21} [<0.001]0.02 (0–0.52) {21} [<0.001]−0.49 (−0.82 to −0.11) {21} [<0.001]−0.6 (−1.0 to −0.37) {19} [<0.001]
IA-2A11.0 (1.8–23.1) {22}7.5 (0.69–20) {21} [0.01]4.5 (0.2–16.3) {22} [0.01]4.1 (0–16.5) {20} [NS]2.9 (0–14.5) {21} [0.001]2.2 (0–9.9) {18} [<0.001}2.3 (0–8.9) {18} [<0.001]−3.8 (−7.5 to −0.35) {20} [0.001]−7.2 (−12.7 to −2.3) {16} [<0.001]
GADA2.5 (0.7–12.3) {23}1.7 (0.3–6.4) {21} [NS]1.95 (0.2–9.2) {22} [NS]2.0 (0.5–15.7) {20} [NS]2.6 (0.3–15.8) {22} [NS]1.9 (0.4–5.3) {18} [0.01]1.2 (0.2–8.9) {19} [NS]−1.0 (−3.6 to 0.6) {22} [NS]−0.8 (−8.4 to 0) {18} [NS]
WBC (cell × 109/L)5.6 (5.0–7.3) {23}5.75 (4.7–7.85) {24} [NS]6.1 (4.7–6.9) {23} [NS]5.8 (4.6–6.9) {20} [NS]5.5 (4.4–6.7) {22} [NS]5.8 (3.9–7.6) {18} [NS]5.5 (4.25–7.35) {20} [NS]−0.4 (−0.7 to 0.2) {22} [NS]−0.5 (−1.8 to 0.6) {19} [NS]
CD4-to-CD8 ratio1.89 (1.5–2.4) {22}1.89 (1.6–2.2) {23} [NS]1.89 (1.5–1.9) {23} [NS]1.96 (1.6–2.2) {20} [NS]1.97 (1.7–2.2) {22} [NS]1.90 (1.4–2.1) {18} [NS]2.15 (1.7–2.4) {20} [NS]0.1 (−0.28 to −0.24) {21} [NS]0.15 (−0.2 to −0.4) {18} [NS]
Peripheral blood Treg (%)3.1 (0.8–5.4) {22}4.1 (1.0–5.5) {23} [NS]4.4 (2.0–7.5) {23} [0.04]3.6 (1.9–5.1) {20} [NS]4.4 (2.0–7.6) {22} [NS]3.0 (1.8–5.1) {20} [NS]3.3 (1.9–6.5) {20} [NS]0.13 (−1.3 to 1.0) {21} [NS]0.52 (−1.8 to 2.9) {18} [NS]
CD45RA Treg (%)39.0 (25.7–45.9) {22}42.6 (27.8–49.8) {23} [NS]40.5 (34.1–51.3) {23} [NS]43.5 (37.9–54.3) {20} [0.001]40.9 (31.9–50.4) {22} [NS]40.2 (29.9–46.2) {18} [NS]42.8 (28.6–48.8) {20} [NS]2.24 (−5.53 to 11.0) {21} [NS]1.82 (−3.8 to 1.8) {18} [NS]
  • Data are median (interquartile range) and {n} [P value vs. baseline]; N = 24 (10 males, 14 females), median age at infusion 5.1 years (3.4–6.9). IA-2A, insulinoma-associated 2 antibody; GADA, GAD antibody; WBC, white blood cell count.