Effect of BM-MSCs on Chronic AMR After Kidney Transplantation

Status Not yet recruiting

Clinical Trial Summary

This study is designed to investigate the efficacy and safety of allogeneic bone marrow-derived mesenchymal stem cells (BM-MSCs) on chronic antibody-mediated rejection (cAMR) after kidney transplantation. Chronic AMR is diagnosed according to Banff criteria 2013 based on renal graft biopsy and donor specific antibodies (DSA) examination. cAMR patients are assigned to MSCs group or control group. Patients in control group are prescribed to current desensitization therapy including at least one of the following treatments: plasmapheresis (PP), intravenous immunoglobulin (IVIG), rituximab or Bortezomib, depending on individual pathological and immunological features (eg. DSA type and titer) of each study subjects. Patients in MSCs group receive additional BM-MSCs therapy besides desensitization treatments as in control group. Allogeneic BM-MSCs (1*10^6/kg) are intravenously administered every two weeks for four consecutive doses. All cAMR patients are followed up for one year. Renal function, DSA level, pathological features, patient/graft survival, and severe adverse events are monitored during the follow-up period. Immunological features of patients in both groups are consecutively examined.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Kidney Transplantation

Clinical Trial Details

NCT number	NCT02563340
Study type	Interventional
Source	First Affiliated Hospital, Sun Yat-Sen University
Contact	Changxi Wang, M.D., Ph.D
Phone	86-20-87333428
Email	wangchx@mail.sysu.edu.cn
Status	Not yet recruiting
Phase	Phase 1/Phase 2
Start date	November 2015
Completion date	November 2017

View Details

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