A Phase 1/2 interventional study of SVFderived MSC transplantations and Basiliximab in Uremia, sponsored by Fuzhou General Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-07-08.
Sponsored by Fuzhou General Hospital · Phase 1/2, Interventional, and Treatment
The objective of this trial is to determine if autologous Stromal Vascular Fraction (SVF) derived Mesenchymal Stem Cell (MSC) infusion during and after kidney transplantation from Donation after Citizen Death (DCD) can effectively reduce the need for post transplant immunosuppressant and elevate GFR of allograft. The investigators will infuse autologous SVF derived MSC to the recipients during and after operation to assess the effect of SVF derived MSC and closely monitor renal function, dosage of immunosuppressant, acute rejection, and graft survival. 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 DCD 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. Kidneys from the same donor of DCD will be random allocated to intervention group and control group. In intervention group the investigators 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 DCD kidney transplantation during operation and on 7, 14, 21 POD. The investigators will assess whether induction therapy with autologous SVF derived MSC is feasible in DCD 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, the investigators 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.
Exclusion Criteria:
Recipients at risk for tuberculosis (TB)
(I). Within the last 2 years, even if treated (II) Greater than 2 years ago, unless there is documentation of adequate treatment according to locally accepted clinical practice c. Recipients at risk of reactivation of TB precludes administration of conventional immunosuppressant (as determined by investigator and based upon appropriate evaluation)
transplantation of autologous SVF derived MSC to the recipients of DCD kidney transplant. 1. Subjects with uremia in the intervention group will undergo puncture to collect SVF 2. SVF will be cultured to abstain MSC 3. The abstained MSC will be infused to the recipients during kidney transplant operation and on 7, 14, and 21 POD.
Other: SVFderived MSC transplantations
induction with Basiliximab during kidney transplantation from DCD
Drug: Basiliximab
infusion of autologous SVF derived MSC to the recipients of DCD 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. And the induction therapy of control group will be Basiliximab.
induction with Basiliximab before kidney transplantation and on POD 4
Effects of autologous SVF derived MSC transplantation on reducing the dosage of CNI by 30% in Kidney Transplantation from Chinese Donation after Citizen Death
Changes of the immunosuppressant by reducing 30% of CNI dosage.
Time frame: 1 years
Changes in renal function as determined by eGFR and proteinuria
Changes in renal function as determined by estimated glomerular filtration rate (eGFR) and proteinuria (\>1g)
Time frame: 1 year
Incidence of Acute rejection
Incidence of acute rejection (biopsy confirmed acute rejection)
Time frame: 1 year
Incidence of delayed graft function (DGF)
Incidence of delayed graft function (defined as need for post-transplant dialysis within one week)
Time frame: 3 months
Allograft survival
Allograft survival at 1 year post transplant
Time frame: 1 year
SAE (severe adverse effects)
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
This study is status unknown, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Fuzhou General Hospital