drugset / Trial / NCT02490020

A Perspective Multicenter Controlled Study On Application Of Mesenchymal Stem Cell(MSC) To Prevent Rejection After Renal Transplantation By Donation After Cardiac Death

NCT02490020

RandomizedParallel-groupSingle-blindPrevention

Summary

Although donation after cardiac death(DCD) is the major source of renal transplantation in China, high incidence rate of rejection and delayed graft function(DGF) is existing due to the prolonged ischemia time. According to the previous single center study, mesenchymal stem cell (MSC) had an effect to prevent rejection and DGF after renal transplantation, but there was no perspective multicenter controlled study to confirm it. This perspective multicenter controlled study will focus on clarifying the key role of MSC applied via renal arterial or peripheral vein injection, to reduce the rejection and DGF after renal transplantation. The investigators have established GMP workshop and solid research foundation of transplant rejection. This study will provide a new reasonable way for immune induction of renal transplantation by DCD.

Timeline

Start
2016-01
Primary completion
2016-12
Completion
2018-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Mesenchymal stem cell Cell therapy 2e+06 cells/kg Intravenous
Subject Mesenchymal stem cell Cell therapy 5e+06 cells Intravenous