The objective of this trial is to determine if autologous SVF derived MSC can effectively reduce the need for post transplant immunosuppressant in living-relative kidney transplantation. 120 patients eligible for the study as described below will be enrolled, with 60 patients in intervention group and 60 in control group.
The objective of this trial is to determine if autologous SVF derived MSC can effectively reduce the need for post transplant immunosuppressant in living-relative kidney transplantation. Emphasis will be placed on the safety of autologous SVF derived MSC infusion, dosage of immunosuppressant, GFR, percentage of acute rejection. 120 patients eligible for the study as described below will be enrolled, with 60 patients in intervention group and 60 in control group. In interventional group we will collect SVF from recipients with special instruments before transplantation, and culture SVF to abstain MSC. The abstained MSC will be infused to the recipients of living-relative kidney transplantation during operation and on 7, 14, 21 POD. We will assess whether induction therapy with autologous SVF derived MSC is feasible in living-relative donor kidney transplantation. The effectiveness of autologous SVF derived MSC induction therapy on reducing of immunosuppressant, reducing the rate of rejection, elevating patient and allograft survival, improving allograft function from day 0 to 12 months after transplantation. Additionally, we will assess the percentage of acute rejection or antibody mediated rejection by Banff criteria, the incidence of delayed graft function (defined as the need for post-transplant dialysis within one week), and the incidence of adverse events including infection, grade 3 and above non-hematologic toxicities, and grade 4 hematologic toxicities.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Procedure: infusion of autologous SVF derived MSC to the recipients of living-relative kidney transplant. Subjects with uremia in the intervention group will undergo puncture to collect SVF, then SVF will be cultured to abstain MSC, and the abstained MSC will be infused to the recipients during kidney transplant operation and on 7, 14, and 21 POD
The control group will be inducted with Basiliximab before living-relative kidney transplantation and on POD 4
Xi er huan road No.156
Fuzhou, Fujian, China
RECRUITINGXi er huan road No.156
Fuzhou, Fujian, China
RECRUITINGEffects of autologous SVF derived MSC transplantation on reducing the dosage of immunosuppressant in living-related kidney transplant recipients.
Reducing the dosage of immunosuppressant by 30% of CNI in living-related kidney transplant recipients.
Time frame: 1 year
Changes in renal function
• Changes in renal function as determined by estimated glomerular filtration rate (eGFR) and proteinuria (\>1g) at 1 year post transplant
Time frame: 1 year
Incidence of acute rejection
Incidence of acute rejection (biopsy confirmed acute rejection according to Banff creteria)
Time frame: 1 year
Incidence of delayed graft function
Incidence of delayed graft function (defined as need for post-transplant dialysis within one week)
Time frame: 1 month
Allograft survival
Allograft survival at 1 year post transplant
Time frame: 1 year
Infection adverse event
Incidence of death, allograft loss, and hospitalization due to infection at 1 year.
Time frame: 1 year
Non-hematologic toxicities
Incidence of grade 3 and above non-hematologic toxicities
Time frame: 1 year
Hematologic toxicities
Incidence of grade 4 hematologic toxicities
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Time frame: 1 year