Table 1 –
Demographic characteristics of the participants with failed or functioning islet grafts.
| Demographic characteristics | ITx recipients who developed graft failure (n=17) | ITx recipients with current graft function [n=18 (IA, n=15; IAK, n=3] | P-valuea | |
|---|---|---|---|---|
| IA group (n=13) | ITx+BM group (n=4) | |||
| Female, n (%) | 7 (54 ) | 3 (75) | 12 (67) | 0.663 |
| Age at first transplant, years | 44±10.5 | 41±1.9 | 44.6±5.9 | 0.697 |
| Duration of T1D at transplant, years | 17 (14 – 37) | 37 (25 – 40) | 38 (29 – 43) | 0.114 |
| Number of islet infusions | 2 (1 – 3) | 1 | 2 (1 – 2) | 0.059 |
| Total IEQ/Kg body weight | 13 185 (6311 – 15 590) | 7289 (7042 – 10 009) | 14 067 (11 291 – 17 179) | 0.181 |
| Body weight, Kg | 68.6 (60 – 74) | 59 (55.8 – 76) | 60 (54 – 67) | 0.188 |
| Immunosuppression Edmonton Protocol | 11 (85) | 4 (100) | 9 (50) | 0.024 |
| Immunosuppression T cell depletion | 2 (15) | 0 | 9 (50) | 0.024 |
| Duration of graft function (years) | 3.3 (1.9 – 5.0)c | 1.25 (0.8 – 1.3)c | 12.35 (7.5 – 14.8) | <0.001 |
| Years of graft failure at enrolment | 4 (2 – 5) | 8 (8 – 9) | n/a | 0.001 |
| Years of graft failure at last follow-up | 9.85±2.6 | 15±0.81 | n/a | <0.001 |
| Years to graft failure after first infusion | 3 (1– 5) | 0.5 (0 – 1) | n/a | 0.023 |
| Years to graft failure after last infusion | 1 (1 – 4) | 0.5 (0 – 1) | n/a | 0.079 |
| CMV IgG-positivity, n (%) | 8 (61.5) | 3 (75) | 5 (27.8) | 0.075 |
| DSA, n (%) | 6 (46.2) | 3 (75) | 2 (11.1)d | 0.014 |
| DSA toward how many donors | 2 (1 – 3) | 1 | 1 | 0.104 |
| DSA toward HLA I, n (%) | 6 (46.2)c,d | 3 (75)c,d | 1 (5.6) | 0.003 |
| DSA toward HLA II, n (%) | 3 (23.1)c,d | 3 (75)c,d | 1 (5.6) | 0.013 |
| HLA I mismatches | 8 (6 – 10) | 5 (4 – 6)b | 6 (5 – 7)b | 0.035 |
| HLA II mismatches | 3 (2 – 4) | 3 (3 – 4) | 2 (2 – 5) | 0.789 |
| Autoantibodies 0/1/2/converter,e n (%) | n=5/5/1/1 (42/42/8/8) # | n=1/1/1/1 (25/25/25/25) | n=6/3/2/3 (43/21/14/21) § | 0.848 |
Abbreviations: CMV, cytomegalovirus; DSA, donor-specific anti-HLA antibodies; IA, islet transplantation alone; ITx + BM, islet transplantation plus bone marrow- derived CD34+ hematopoietic stem cells; IAK, islet after kidney transplantation; IEQ, islet equivalents; IgG, immunoglobulin G; ITx, islet transplantation; n/a, not applicable; T1D, type 1 diabetes.
Indicates P-value between groups and are according to χ2 test, ANOVA, independent t-test, U Mann-Whitney or Kruskal-Wallis test as appropriate.
Indicates significant difference compared to IA group (P-value <0.05)
indicates significant difference compared to ITx recipients with current graft function (P-value <0.05)
indicates chi-square with significant difference after Bonferroni correction.
Autoantibodies: 0= no antibodies; 1, 1 antibody developed; 2, 2 antibodies developed; converter, individual who became autoantibody-positive during follow up.
Autoantibody assessment was performed only in 11 out of 13 subjects.
Autoantibody assessment was performed only in 14 out of 18 subjects.