Effect of Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cell in Kidney Transplantation From Chinese Donation After Citizen Death (DCD): A Randomized Controlled Trial
Overview
- Phase
- Phase 1
- Intervention
- SVFderived MSC transplantations
- Conditions
- Uremia
- Sponsor
- Fuzhou General Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Effects of autologous SVF derived MSC transplantation on reducing the dosage of CNI by 30% in Kidney Transplantation from Chinese Donation after Citizen Death
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Uremia patient of any race that is greater than or equal to 18 years of age but less than 60 years old
- •Patient is willing to receive a kidney from DCD
- •Patient is willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months
Exclusion Criteria
- •Women who are pregnant, intend to become pregnant in the next 1 years, breastfeeding, or have a positive pregnancy test on enrollment or prior to study medication administration
- •Patient with prior solid organ transplant or cell transplant (e.g. bone marrow or islet cell).
- •Patient is deemed likely to have a second solid organ transplant or cell transplant (e.g. bone marrow or islet cell) in next 3 years
- •Patient receiving a concurrent SOT (heart, liver, pancreas)
- •ABO incompatible donor recipient pair or CDC crossmatch positive transplant
- •Sensitized patients (most recent anti-HLA Class I or II Panel Reactive Antibodies (PRA)\>10% by a CDC-assay) or patients identified a high immunological risk by the transplant physician
- •Donors or recipients are known hepatitis C antibody-positive or polymerase chain reaction (PCR) positive for hepatitis C
- •Donors or recipients are known hepatitis B surface antigen-positive or PCR positive for hepatitis B
- •Donors or recipients are known human immunodeficiency virus (HIV) infection
- •Recipients at risk for tuberculosis (TB)
Arms & Interventions
SVF(Stromal Vascular Fraction) derived MSC transprlantation
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.
Intervention: SVFderived MSC transplantations
Basiliximab
induction with Basiliximab during kidney transplantation from DCD
Intervention: Basiliximab
Outcomes
Primary Outcomes
Effects of autologous SVF derived MSC transplantation on reducing the dosage of CNI by 30% in Kidney Transplantation from Chinese Donation after Citizen Death
Time Frame: 1 years
Changes of the immunosuppressant by reducing 30% of CNI dosage.
Secondary Outcomes
- non-hematologic toxicities(1 year)
- Changes in renal function as determined by eGFR and proteinuria(1 year)
- Incidence of Acute rejection(1 year)
- Incidence of delayed graft function (DGF)(3 months)
- Allograft survival(1 year)
- SAE (severe adverse effects)(1 year)