Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Second Affiliated Hospital of Guangzhou Medical University | OTHER |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSCs group | Experimental | cAMR patients in this group receive additional intravenous allogeneic BM-MSCs (1*10^6/kg) every two weeks for four consecutive doses, besides current desensitization therapy including at least one of the following treatments: plasmapheresis (PP), intravenous immunoglobulin (IVIG), rituximab or Bortezomib. |
|
| Control group | Active Comparator | cAMR patients in this group receive current desensitization therapy including at least one of the following treatments: plasmapheresis (PP), intravenous immunoglobulin (IVIG), rituximab or Bortezomib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BM-MSCs | Other | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimated glomerular filtration rate (eGFR) | eGFR at month 12 after enrollment | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient survival rate | patient survival rate at month 12 after enrollment | 12 months |
| Graft survival rate | graft survival rate at month 12 after enrollment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Changxi Wang, M.D., Ph.D | Contact | 86-20-87333428 | wangchx@mail.sysu.edu.cn | |
| Longshan Liu, M.D., Ph.D | Contact | 86-20-87306082 | liulshan@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Changxi Wang, M.D., Ph.D | First Affiliated Hospital, Sun Yat-Sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23263506 | Background | Peng Y, Ke M, Xu L, Liu L, Chen X, Xia W, Li X, Chen Z, Ma J, Liao D, Li G, Fang J, Pan G, Xiang AP. Donor-derived mesenchymal stem cells combined with low-dose tacrolimus prevent acute rejection after renal transplantation: a clinical pilot study. Transplantation. 2013 Jan 15;95(1):161-8. doi: 10.1097/TP.0b013e3182754c53. |
| Label | URL |
|---|---|
| Previous publication | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D016756 | Immunoglobulins, Intravenous |
| D000069283 | Rituximab |
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D007074 | Immunoglobulin G |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Desensitization therapy (PP, IVIG, rituximab or Bortezomib) | Other | 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. |
|
| 12 months |
| Donor specific antibody (DSA) level | Change of DSA level up to 12 months after enrollment | 12 months |
| Pathological manifestation | Change of pathological scores according to Banff 2013 criteria | 12 months |
| Severe adverse events | 12 months |
| D007132 |
| Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |