NCT02563366

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

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 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 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.

Conditions

• Kidney Transplantation
• Acute Kidney Tubular Necrosis

Interventions

Type	Name	Description
OTHER	BM-MSCs	BM-MSCs are from third-party healthy volunteer donors.
OTHER	Saline	Saline is the placebo of MSCs in this study.

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-10-01
• Completion: 2017-12-01
• First posted: 2015-09-30
• Last updated: 2015-09-30

Locations

1 site across 1 country: China