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A randomized pilot study of donor stem cell infusion in living-related kidney transplant recipients receiving alemtuzumab.

ABSTRACT: BACKGROUND:Transplant tolerance would remove the need for maintenance immunosuppression while improving survival and quality of life. METHODS:A prospective, randomized pilot study was undertaken to assess the safety and efficacy of donor stem cell infusion (DSCI) in living-related kidney transplant recipients treated with alemtuzumab (C1H) induction and tacrolimus and mycophenolate maintenance with switch to sirolimus and weaning over 2 years. RESULTS:Four patients received DSCI; five patients were controls. Graft failure occurred in two patients in the DSCI arm. Recurrence of glomerular disease occurred in two DSCI recipients, leading to graft loss in one. Biopsy-proven acute rejection episodes occurred in three patients (two in the DSCI vs. one in the control). One DSCI patient, with recurrence, subsequently developed antibody-mediated rejection leading to graft failure. In the remaining two DSCI patients, weaning was attempted but was not successful. All (4 of 4) DSCI patients had biopsy-proven chronic allograft injury and/or recurrence. CONCLUSION:DSCI with C1H induction and a steroid-free maintenance regimen in a small group of patients failed to induce tolerance, with suboptimal patient and graft survival. The results do not justify extension of this particular trial and underscore the importance of patient selection, specifically avoidance of patients with glomerulopathies whose recurrence may obscure potential benefit.

SUBMITTER: Ciancio G

PROVIDER: S-EPMC3818358 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature

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A randomized pilot study of donor stem cell infusion in living-related kidney transplant recipients receiving alemtuzumab.

Ciancio Gaetano G Sageshima Junichiro J Akpinar Edip E Gaynor Jeffrey J JJ Chen Linda L Zarak Alberto A Hanson Lois L Tueros Lissett L Guerra Giselle G Mattiazzi Adela A Kupin Warren W Roth David D Ricordi Camillo C Burke George W GW

Transplantation 20131101 9

<h4>Background</h4>Transplant tolerance would remove the need for maintenance immunosuppression while improving survival and quality of life.<h4>Methods</h4>A prospective, randomized pilot study was undertaken to assess the safety and efficacy of donor stem cell infusion (DSCI) in living-related kidney transplant recipients treated with alemtuzumab (C1H) induction and tacrolimus and mycophenolate maintenance with switch to sirolimus and weaning over 2 years.<h4>Results</h4>Four patients received ...[more]

PMID: 23903014

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Project description:BackgroundLong-term kidney transplant survival at the population level is consistently favorable, but this survival varies widely at an individual level due to both recipient and donor factors. The distinct contribution of recipient and donor factors to individual post kidney transplant outcome remains unclear. Comparing outcomes in deceased donor (DD) recipients with potential but non-actualized living donors (DD1) to those recipients with actualized living donors (LD), and to DD recipients without potential living donors (DD0) may provide transplant candidates with more information about their own post-transplant prognosis.MethodsWe conducted an observational retrospective cohort study of kidney transplant candidates presenting to our centre for evaluation between 01/01/06 and 31/12/18, and who also received a transplant during that time. Patients were followed to 31/08/2019. Candidates were classified as DD0, DD1, or LD based on whether they had an identified living donor at the time of initial pre-transplant assessment, and if the donor actualized or not. Primary outcome was 5-year death-censored graft survival, adjusted for common pre- and post-transplant donor and recipient risk factors. Secondary outcomes analyzed included patient survival and graft function.ResultsThere were 453 kidney transplant recipients (LD = 136, DD1 = 83, DD0 = 234) who received a transplant during the study period. DD0 and DD1 did not differ in key donor organ characteristics. The 5-year death censored graft survival of DD1 was similar to LD (p = 0.19). DD0 graft survival was inferior to LD (p = 0.005), but also trended inferior to DD1 (p = 0.052). By multivariate Cox regression analysis, LD demonstrated similar 5-year graft survival to DD1 (HR for graft loss 0.8 [95% CI 0.25-2.6], p = 0.72) but LD graft survival was superior to DD0 (HR 0.34 [0.16-0.72], p = 0.005). The 5-year patient survival in DD1 was similar to LD (p = 0.26) but was superior to DD0 (p = 0.01).ConclusionsDD recipients with potential but non-actualized living donors exhibit similar mid-term graft and patient survival compared to LD recipients. Having an identified living donor at the time of pre-transplant assessment portends a favorable prognosis for the recipient.

Dataset Information

A randomized pilot study of donor stem cell infusion in living-related kidney transplant recipients receiving alemtuzumab.

Publications

A randomized pilot study of donor stem cell infusion in living-related kidney transplant recipients receiving alemtuzumab.

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