NCT02492490

Effect of SVF Derived MSC in DCD Renal Transplantation

Effect of Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cell in Kidney Transplantation From Chinese Donation After Citizen Death (DCD): A Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Fuzhou General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Uremia

Interventions

Type	Name	Description
OTHER	SVFderived MSC transplantations	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.
DRUG	Basiliximab	induction with Basiliximab before kidney transplantation and on POD 4

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2015-07-08
• Last updated: 2015-07-08

Locations

1 site across 1 country: China