NCT02561767

Effect of BM-MSCs in DCD Kidney Transplantation

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplantation
• Acute Kidney Tubular Necrosis

Interventions

Type	Name	Description
OTHER	bone marrow-derived mesenchymal stem cells	BM-MSCs is harvested from third-party health volunteer donors.
OTHER	Saline	Saline as placebo of MSCs
DRUG	Induction therapy (ATG or Basiliximab)	ATG, antithymocyte globulin; Basiliximab, anti-CD25 mAb. Recipients receive ATG or Basiliximab as induction therapy in both MSCs group and control group.
DRUG	Maintenance therapy (Low-dose CNI + MPA + steroids)	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.

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-10-01
• Completion: 2017-10-01
• First posted: 2015-09-28
• Last updated: 2015-09-28

Locations

1 site across 1 country: China