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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
BM-MSCs is harvested from third-party health volunteer donors.
Saline as placebo of MSCs
ATG, antithymocyte globulin; Basiliximab, anti-CD25 mAb. Recipients receive ATG or Basiliximab as induction therapy in both MSCs group and control group.
Maintenance immunosuppressive therapy consists of low-dose tacrolimus and mycophenolic acid and steroids. Recipients receive the same maintenance therapy in both MSCs group and control group.
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Estimated glomerular filtration rate
eGFR at one month post-transplant
Time frame: 1 month
Incidence of slow graft function
Time frame: 12 months
Incidence of delayed graft function
Time frame: 12 months
Proportion of normal renal function recovery
Time frame: 12 months
Time to renal function recovery
Time frame: 12 months
Patient survival
Time frame: 12 months
Renal graft survival
Time frame: 12 months
Incidence of acute rejection
Time frame: 12 months
Severe adverse events
Time frame: 12 months
Estimated glomerular filtration rate
eGFR up to 12 months post-transplant
Time frame: 12 months
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