This study is designed to investigate whether allogeneic bone marrow-derived mesenchymal stem cells (BM-MSCs) can promote function recovery in patients with poor early graft function after kidney transplantation from Chinese Donation after Citizen Death (DCD). DCD kidney transplant recipients with poor early graft function (with or without dialysis) post transplant are equally randomized into MSCs group or control group. Patients in MSCs group are administered MSCs treatment. Allogeneic BM-MSCs (1\*10\^6/kg) from third party are given intravenously for four consecutive doses every week after enrollment. Patients in control group receive placebo. Renal allograft function (eGFR), rejection, patient/graft survival and severe adverse events up to 12 months post enrollment are monitored.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
BM-MSCs are from third-party healthy volunteer donors.
Saline is the placebo of MSCs in this study.
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
Estimated glomerular filtration rate
eGFR up to 12 months post transplant
Time frame: 12 months
Proportion of normal renal function recovery
Time frame: 12 months
Time to renal function recovery (days)
Time frame: 12 months
acute rejection rate
Acute rejection rate according to Banff 2013 criteria up to 12 months post transplant
Time frame: 12 months
patient and graft survival rate
patient and graft survival rate up to 12 months post transplantation
Time frame: 12 months
Incidence of severe adverse events
Incidence of severe adverse events up to 12 months post transplantation
Time frame: 12 months
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