Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this study is to evaluate autologous MSCs as an alternative for antibody induction therapy in renal transplantation.
Renal transplantation is the most common and successful type of organ transplantation. Induction therapy with antibody plus the maintenance immunosuppressive agents have greatly improved graft survival in renal transplantation. Since mesenchymal stem cells(MSCs)have been used successfully to treat graft versus host disease and show immune modulation function both in vitro and in vivo and may help in repairing damaged tissue(s), we evaluate autologous MSCs as an alternative for antibody induction therapy. Moreover, we examine if MSCs could improve the recovery of early function in transplanted kidney.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Patients in Group A will receive MSCs instead of anti-interleukin 2 receptor antibody for induction therapy. The first MSCs infusion intravenously will be right at releasing renal artery clamp to establish allograft blood flow and the second infusion of MSCs will be performed two weeks after transplantation. Patients will receive standard regular immunosuppressive agents including calcineurin inhibitor, glucocorticoid, and MMF. |
|
| B | Active Comparator | Patients in Group B will receive MSCs instead of anti-interleukin 2 receptor antibody for induction therapy. The first MSCs infusion intravenously will be right at releasing renal artery clamp to establish allograft blood flow and the second infusion of MSCs will be performed two weeks after transplantation. Patients will receive 80% less of calcineurin inhibitor than in Group A. Other immunosuppressive agents such as glucocorticoid and MMF remained the same doses as in Group A. |
|
| C | Active Comparator | Patients in Group C will receive anti-interleukin 2 receptor antibody (Basiliximab)for induction therapy. Patients will receive the same doses of regular immunosuppressive agents including calcineurin inhibitor, glucocorticoid, and MMF as in Group A. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kidney transplantation with MSCs infusion | Procedure | Patients in Group A will receive the first MSCs infusion intravenously within 24 hours after kidney transplant operation , and the second infusion of MSCs will be performed two weeks later. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of biopsy-proven acute rejection and early renal function recovery | At 1 year post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Patient and graft survival and prevalence of adverse events | At 1 year post-transplant |
Not provided
Inclusion Criteria:
Note: The subjects do not need to be local residents in order to be eligible for this trial, but must be willing to reside in the area, or within a four hour drive, for the first three months of the protocol so that we can monitor them closely in the early post transplant period.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jianming Tan, M.D and Ph.D | Fuzhou General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stem cell therapy center,Fuzhou General Hospital | Fuzhou | Fujian | 350025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22436957 | Derived | Tan J, Wu W, Xu X, Liao L, Zheng F, Messinger S, Sun X, Chen J, Yang S, Cai J, Gao X, Pileggi A, Ricordi C. Induction therapy with autologous mesenchymal stem cells in living-related kidney transplants: a randomized controlled trial. JAMA. 2012 Mar 21;307(11):1169-77. doi: 10.1001/jama.2012.316. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016030 | Kidney Transplantation |
| C485557 | cni protein, Drosophila |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| kidney transplantation without MSC infusion | Procedure | kidney transplantation with standard immunosuppressive treatment regime |
|
|
| D013514 |
| Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |