Effect of Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cell in Living-Related Kidney Transplants: A Randomized Controlled Trial
Overview
- Phase
- Phase 1
- Intervention
- SVF-MSC induction
- Conditions
- Living-relative Kidney Transplantation
- Sponsor
- Fuzhou General Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Effects of autologous SVF derived MSC transplantation on reducing the dosage of immunosuppressant in living-related kidney transplant recipients.
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
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 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.
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 a certifiable living-relative donor 18-60 years of age
- •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 with cardiac death (non-heart beating donor) 8 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-MSC induction
1. collection of autologous SVF 2. culture of SVF to abstain MSC 3. infusion of MSC during and after living-relative kidney transplantation
Intervention: SVF-MSC induction
Basiliximab induction
The control group will be inducted with Basiliximab
Intervention: Basiliximab induction
Outcomes
Primary Outcomes
Effects of autologous SVF derived MSC transplantation on reducing the dosage of immunosuppressant in living-related kidney transplant recipients.
Time Frame: 1 year
Reducing the dosage of immunosuppressant by 30% of CNI in living-related kidney transplant recipients.
Secondary Outcomes
- Allograft survival(1 year)
- Changes in renal function(1 year)
- Incidence of acute rejection(1 year)
- Hematologic toxicities(1 year)
- Incidence of delayed graft function(1 month)
- Infection adverse event(1 year)
- Non-hematologic toxicities(1 year)