A Perspective Multicenter Controlled Study On Application Of Mesenchymal Stem Cell(MSC) To Prevent Rejection After Renal Transplantation By Donation After Cardiac Death
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 260
- Primary Endpoint
- Incident rates of BPAR and DGF after renal transplantation with MSC prevention before operation
Study Overview
Brief Summary
Although donation after cardiac death(DCD) is the major source of renal transplantation in China, high incidence rate of rejection and delayed graft function(DGF) is existing due to the prolonged ischemia time. According to the previous single center study, mesenchymal stem cell (MSC) had an effect to prevent rejection and DGF after renal transplantation, but there was no perspective multicenter controlled study to confirm it. This perspective multicenter controlled study will focus on clarifying the key role of MSC applied via renal arterial or peripheral vein injection, to reduce the rejection and DGF after renal transplantation. The investigators have established GMP workshop and solid research foundation of transplant rejection. This study will provide a new reasonable way for immune induction of renal transplantation by DCD.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Study on prevention of MSC to rejection after transplantation
- •Age between 18-60 years
- •having the indication of renal transplantation
- •having no absolute contraindication
- •renal transplantation by donation after citizen death
- •the first time to receive renal transplantation
- •signed informed consent
- •Study on treatment of MSC to rejection after transplantation
- •renal transplantation by donation after citizen death
- •having no contraindication of renal biopsy
- •signed informed consent
Exclusion Criteria
- •loss to follow-up
- •serious adverse events
Outcomes
Primary Outcomes
Incident rates of BPAR and DGF after renal transplantation with MSC prevention before operation
Time Frame: up to one year
Cases enrolled into the group will be monitored renal function,renal biopsy and other opportunistic infection.The incident rates of DGF and BPAR will be calculated and compare with the control group.
Numbers of participants enrolled into the MSC group and control group
Time Frame: up to one year
80-100 cases will be enrolled to the group.
Secondary Outcomes
No secondary outcomes reported
Investigators
Qipeng Sun
MD
Third Affiliated Hospital, Sun Yat-Sen University