Overview

Effect of BM-MSCs in DCD Kidney Transplantation

Status:
Unknown status
Trial end date:
2017-10-01
Target enrollment:
Participant gender:
Summary
This study is designed to determine the efficacy and safety of allogeneic bone marrow-derived mesenchymal stem cells in kidney transplantation from Chinese donation after citizen's death (DCD). A pair uremia patients receiving kidney grafts from a same donor are randomized into two groups: MSCs group and control group. Besides routine induction therapy (ATG or Basiliximab) and maintenance immunosuppressive drugs (low-dose Tacrolimus + MPA + prednisone), patients in MSCs group are administered MSCs treatment (1*10^6/kg). Allogeneic bone marrow-derived MSCs (1*10^6/kg) are given intravenously at day 0 (post renal reperfusion during surgery), day 7, day 14 and day 21. The renal allograft function, rejection, patient/graft survival and severe adverse events within 12 months post-transplant are monitored.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
First Affiliated Hospital, Sun Yat-Sen University
Collaborator:
Second Affiliated Hospital of Guangzhou Medical University
Treatments:
Antibodies, Monoclonal
Basiliximab
Mycophenolate mofetil
Mycophenolic Acid
Tacrolimus