Clinical Trial: Effect of BM-MSCs in DCD Kidney Transplantation
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: The Efficacy and Safety of Bone Marrow-derived Mesenchymal Stem Cells in Kidney Transplantation From Chinese Donation After Citizen Death (DCD): A Multi-center Randomized Controlled Trial
Brief 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.
Detailed Summary:
Sponsor: First Affiliated Hospital, Sun Yat-Sen University
Current Primary Outcome: Estimated glomerular filtration rate [ Time Frame: 1 month ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 [ Time Frame: 12 months ]eGFR up to 12 months post-transplant
Original Secondary Outcome:
- 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 [ Time Frame: 12 months ]eGFR at week 2, mon 3, mon 6 and month 12 post-transplant
Information By: First Affiliated Hospital, Sun Yat-Sen University
Dates:
Date Received: September 25, 2015
Date Started: October 2015
Date Completion: October 2017
Last Updated: September 25, 2015
Last Verified: September 2015