Clinical Trial: Effect of BM-MSCs on Early Graft Function Recovery After DCD Kidney Transplant.

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Effect of Bone Marrow-derived Mesenchymal Stem Cells (BM-MSCs) on Recovery of Poor Early Graft Function Post Kidney Transplantation From Chinese Donation After Citizen Death (DCD): A Multi-center Rand

Brief Summary: 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.

Detailed Summary:
Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Current Primary Outcome: Estimated glomerular filtration rate [ Time Frame: 1 month ]

eGFR at one month post transplant


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Estimated glomerular filtration rate [ Time Frame: 12 months ]
    eGFR up to 12 months post transplant
  • Proportion of normal renal function recovery [ Time Frame: 12 months ]
  • Time to renal function recovery (days) [ Time Frame: 12 months ]
  • acute rejection rate [ Time Frame: 12 months ]
    Acute rejection rate according to Banff 2013 criteria up to 12 months post transplant
  • patient and graft survival rate [ Time Frame: 12 months ]
    patient and graft survival rate up to 12 months post transplantation
  • Incidence of severe adverse events [ Time Frame: 12 months ]
    Incidence of severe adverse events up to 12 months post transplantation


Original Secondary Outcome: Same as current

Information By: First Affiliated Hospital, Sun Yat-Sen University

Dates:
Date Received: September 26, 2015
Date Started: November 2015
Date Completion: December 2017
Last Updated: September 28, 2015
Last Verified: September 2015