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

NCT02563366 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-09-30

No results posted yet for this study

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

OTHER

BM-MSCs

BM-MSCs are from third-party healthy volunteer donors.

OTHER

Saline

Saline is the placebo of MSCs in this study.

Sponsors & Collaborators

  • Second Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER

  • First Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Changxi Wang, M.D., Ph.D · First Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-10-31
Completion
2017-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02563366 on ClinicalTrials.gov