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| Name | Class |
|---|---|
| Zhujiang Hospital | OTHER |
| The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine | OTHER |
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Although donation after cardiac death(DCD) is the major source of renal transplantation in China, high incidence rate of rejection and delayed graft function(DGF) is existing due to the prolonged ischemia time. According to the previous single center study, mesenchymal stem cell (MSC) had an effect to prevent rejection and DGF after renal transplantation, but there was no perspective multicenter controlled study to confirm it. This perspective multicenter controlled study will focus on clarifying the key role of MSC applied via renal arterial or peripheral vein injection, to reduce the rejection and DGF after renal transplantation. The investigators have established GMP workshop and solid research foundation of transplant rejection. This study will provide a new reasonable way for immune induction of renal transplantation by DCD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iv of BMSC to prevent rejection | Experimental | Routine treatment protocol(ATG 50mg*3;MP 2.0g to Pred 30mg,then maintaining 5mg qd;MMF 1.0 bid from the first day after op,then maintaining 1-1.5g/d;Plus CNI from the third day after op)+BMSC iv(2*10^6cell/kg, 48h before op) |
|
| routine treatment protocol to prevent rejection | No Intervention | Routine treatment protocol(ATG 50mg*3;MP 2.0g to Pred 30mg,then maintaining 5mg qd;MMF 1.0 bid from the first day after op,then maintaining 1-1.5g/d;Plus CNI from the third day after op) | |
| ia and iv of MSC to prevent rejection | Experimental | Routine treatment protocol(ATG 50mg*3;MP 2.0g to Pred 30mg,then maintaining 5mg qd;MMF 1.0 bid from the first day after op,then maintaining 1-1.5g/d;Plus CNI from the third day after op)+BMSC (iv 2*10^6cell/kg + ia 5*10^6cell, 48h before op) |
|
| routine treatment to prevent rejection | No Intervention | Routine treatment protocol(ATG 50mg*3;MP 2.0g to Pred 30mg,then maintaining 5mg qd;MMF 1.0 bid from the first day after op,then maintaining 1-1.5g/d;Plus CNI from the third day after op) | |
| Routine CMR treatment plus MSC to prevent CMR | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mesenchymal stem cell | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of participants enrolled into the MSC group and control group | 80-100 cases will be enrolled to the group. | up to one year |
| Incident rates of BPAR and DGF after renal transplantation with MSC prevention before operation | Cases enrolled into the group will be monitored renal function,renal biopsy and other opportunistic infection.The incident rates of DGF and BPAR will be calculated and compare with the control group. | up to one year |
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Inclusion Criteria:
Study on prevention of MSC to rejection after transplantation
Study on treatment of MSC to rejection after transplantation
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qiquan Sun, MD,PhD | Third Affiliated Hospital, Sun Yat-Sen University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29514693 | Derived | Sun Q, Huang Z, Han F, Zhao M, Cao R, Zhao D, Hong L, Na N, Li H, Miao B, Hu J, Meng F, Peng Y, Sun Q. Allogeneic mesenchymal stem cells as induction therapy are safe and feasible in renal allografts: pilot results of a multicenter randomized controlled trial. J Transl Med. 2018 Mar 7;16(1):52. doi: 10.1186/s12967-018-1422-x. | |
| 29145879 |
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Routine CMR treatment protocol(MP as first line approach, ATG as second line approach,ATG be used to treat BPAR in 1 week after op)+MSC( iv 2*10^6cell/kg at d1,d7)
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| Routine CMR treatment to prevent CMR | No Intervention | Routine CMR treatment protocol(MP as first line approach, ATG as second line approach,ATG be used to treat BPAR in 1 week after op) |
| Routine AMR treatment plus MSC to prevent AMR | Experimental | Routine AMR treatment protocol(plasma exchange and IVIG as first line approach, anti-CD20 monoclonal antibody as second line approach)+MSC( iv 2*10^6cell/kg at d1,d7) |
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| Routine AMR treatment to prevent AMR | No Intervention | Routine AMR treatment protocol(plasma exchange and IVIG as first line approach, anti-CD20 monoclonal antibody as second line approach) |
| Sun Q, Hong L, Huang Z, Na N, Hua X, Peng Y, Zhao M, Cao R, Sun Q. Allogeneic mesenchymal stem cell as induction therapy to prevent both delayed graft function and acute rejection in deceased donor renal transplantation: study protocol for a randomized controlled trial. Trials. 2017 Nov 16;18(1):545. doi: 10.1186/s13063-017-2291-y. |