A randomized pilot study of donor stem cell infusion in living-related kidney transplant recipients receiving alemtuzumab.
Ciancio G, Sageshima J, et al.Transplantation 2013;96(9):800-6
Aims
To investigate 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.
Interventions
All patients received C1H induction on days 0 and 4 after transplantation. Study patients received donor stem cell infusion (DSCI) 5 days and 4 months after transplantation with scheduled maintenance immunosuppression weaning, whereas control patients did not receive DSCI and remained on the same immunosuppression (tacrolimus and mycophenolate mofetil) without weaning.
Participants
9 participants awaiting kidney transplants.
Outcomes
The outcomes for this study included, serum creatinine levels, T-cell mediated rejection, antibody mediated rejection, post transplant donor specific antibodies, chronic allograft injury, primary disease recurrence, proteinuria, graft loss, death, graft versus host disease and severe infection.
Follow-up
2 years
CET Conclusions
This is a small pilot trial in which donor stem cell infusion (SCI) with Campath induction was tested in 9 recipients of 1 haplotype disparate living related donors. Four patients received SCI and 5 not. The plan was to reduce and then stop tacrolimus at 4 months with replacement by sirolimus on a temporary basis. Mycophenolate (MMF) was continued from the time of transplantation. However in the study group there were problems with rejection, and weaning could not be achieved in any patient. Two patients lost their grafts from recurrent disease. Thus this pilot attempt to induce tolerance with Campath and donor bone marrow stem cell infusion in recipients of LRD was nothing short of disastrous and the authors did not feel that this approach could be justified in a larger study. We would agree.
Data analysis
Available case analysis
Trial registration
ClinicalTrials.gov - NCT00183248