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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
BM-MSCs are from third-party healthy donors, and have no HLA alleles similar to renal allograft donors or reacting to positive anti-HLA antibodies in recipients.
At least one drug or treatment is applied as desensitization therapy to decrease DSA, reduce B cells or inhibit plasma cells, depending on individual condition.
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Estimated glomerular filtration rate (eGFR)
eGFR at month 12 after enrollment
Time frame: 12 months
Patient survival rate
patient survival rate at month 12 after enrollment
Time frame: 12 months
Graft survival rate
graft survival rate at month 12 after enrollment
Time frame: 12 months
Donor specific antibody (DSA) level
Change of DSA level up to 12 months after enrollment
Time frame: 12 months
Pathological manifestation
Change of pathological scores according to Banff 2013 criteria
Time frame: 12 months
Severe adverse events
Time frame: 12 months
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