This is a single center, open-label, dose escalation, Phase 1 study to test the safety and feasibility of a single infusion of donor-derived DCreg in de novo living donor renal transplant recipients who will receive mycophenolic acid (MPA), tacrolimus (Tac), and steroid maintenance immunosuppressive therapy without antibody induction. Subjects will not be withdrawn from known effective therapy for the purpose of participating in this research.
DCreg will be prepared from monocytes obtained by leukapheresis from prospective (non-mobilized) living kidney donors and infused into the respective recipients 7 days before renal transplantation. Half dose MPA will be administered concomitant with the DCreg infusion. Study duration will be 5 years (3 years accrual + 2 years follow-up).
Three doses of DCreg will be tested in 3 groups of recipients as follows:
- Dose 1: 0.5 (+/- .1) million cells /kg recipient body wt (3 patients)
- Dose 2: 1.2 (+/- .2) million cells/kg recipient body wt (3 patients)
- Dose 3: 2.5-5.0 million cells/kg recipient body wt (8 patients)