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| Name | Class |
|---|---|
| Second Affiliated Hospital of Guangzhou Medical University | OTHER |
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This study is designed to determine the efficacy and safety of allogeneic bone marrow-derived mesenchymal stem cells in kidney transplantation from Chinese donation after citizen's death (DCD). A pair uremia patients receiving kidney grafts from a same donor are randomized into two groups: MSCs group and control group. Besides routine induction therapy (ATG or Basiliximab) and maintenance immunosuppressive drugs (low-dose Tacrolimus + MPA + prednisone), patients in MSCs group are administered MSCs treatment (1*10^6/kg). Allogeneic bone marrow-derived MSCs (1*10^6/kg) are given intravenously at day 0 (post renal reperfusion during surgery), day 7, day 14 and day 21. The renal allograft function, rejection, patient/graft survival and severe adverse events within 12 months post-transplant are monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSCs group | Experimental | Allogeneic bone marrow-derived mesenchymal stem cells (10^6/kg) from third party donors is intravenously given at day 0 (after renal artery reperfusion), day 7, day 14 and day 21.Induction therapy: ATG or Basiliximab; Maintenance therapy: low-dose Tacrolimus + mycophenolic acid + prednisone. The third-party MSCs have no similar HLA alleles of kidney donors, and have no HLA alleles specific to preformed anti-HLA antibodies in recipients prior to KTx. |
|
| Control group | Placebo Comparator | Placebo (saline) is intravenously given at day 0 (after renal artery reperfusion), day 7, day 14 and day 21. Induction therapy: ATG or Basiliximab; Maintenance therapy: low-dose Tacrolimus + mycophenolic acid + prednisone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bone marrow-derived mesenchymal stem cells | Other | BM-MSCs is harvested from third-party health volunteer donors. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimated glomerular filtration rate | eGFR at one month post-transplant | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of slow graft function | 12 months | |
| Incidence of delayed graft function | 12 months | |
| Proportion of normal renal function recovery |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
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| ID | Term |
|---|---|
| D007683 | Kidney Tubular Necrosis, Acute |
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D020360 | Neoadjuvant Therapy |
| D000077552 | Basiliximab |
| D008283 | Maintenance |
| C485557 | cni protein, Drosophila |
| D013256 | Steroids |
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline | Other | Saline as placebo of MSCs |
|
| Induction therapy (ATG or Basiliximab) | Drug | ATG, antithymocyte globulin; Basiliximab, anti-CD25 mAb. Recipients receive ATG or Basiliximab as induction therapy in both MSCs group and control group. |
|
|
| Maintenance therapy (Low-dose CNI + MPA + steroids) | Drug | Maintenance immunosuppressive therapy consists of low-dose tacrolimus and mycophenolic acid and steroids. Recipients receive the same maintenance therapy in both MSCs group and control group. |
|
|
| 12 months |
| Time to renal function recovery | 12 months |
| Patient survival | 12 months |
| Renal graft survival | 12 months |
| Incidence of acute rejection | 12 months |
| Severe adverse events | 12 months |
| Estimated glomerular filtration rate | eGFR up to 12 months post-transplant | 12 months |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D005159 | Health Care Facilities Workforce and Services |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |