A Perspective Multicenter Controlled Study On Application Of Mesenchymal Stem Cell(MSC) To Prevent Rejection After Renal Transplantation By Donation After Cardiac Death

Phase 1

• Conditions: Disorder Related to Renal Transplantation; Renal Transplant Rejection
• Interventions: Biological: mesenchymal stem cell

• Registration Number: NCT02490020
• Lead Sponsor: Qipeng Sun

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-29
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-02
• Last Update Submitted: 2015-07-02
• Study First Posted: 2015-07-03
• Last Update Posted: 2015-07-03
• Study Start: 2016-01
• Primary Completion: 2016-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

1. 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

2. Study on treatment of MSC to rejection after transplantation

   • renal transplantation by donation after citizen death
   • BPAR
   • having no contraindication of renal biopsy
   • signed informed consent

Exclusion Criteria

• loss to follow-up
• serious adverse events

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iv of BMSC to prevent rejection	mesenchymal stem cell	Routine treatment protocol(ATG 50mg\*3;MP 2.0g to Pred 30mg,then maintaining 5mg qd;MMF 1.0 bid from the first day after op,then maintaining 1-1.5g/d;Plus CNI from the third day after op)+BMSC iv(2\*10\^6cell/kg, 48h before op)
ia and iv of MSC to prevent rejection	mesenchymal stem cell	Routine treatment protocol(ATG 50mg\*3;MP 2.0g to Pred 30mg,then maintaining 5mg qd;MMF 1.0 bid from the first day after op,then maintaining 1-1.5g/d;Plus CNI from the third day after op)+BMSC (iv 2\*10\^6cell/kg + ia 5\*10\^6cell, 48h before op)
Routine AMR treatment plus MSC to prevent AMR	mesenchymal stem cell	Routine AMR treatment protocol(plasma exchange and IVIG as first line approach, anti-CD20 monoclonal antibody as second line approach)+MSC( iv 2\*10\^6cell/kg at d1,d7)
Routine CMR treatment plus MSC to prevent CMR	mesenchymal stem cell	Routine CMR treatment protocol(MP as first line approach, ATG as second line approach,ATG be used to treat BPAR in 1 week after op)+MSC( iv 2\*10\^6cell/kg at d1,d7)

Primary Outcome Measures

Name	Time	Method
Incident rates of BPAR and DGF after renal transplantation with MSC prevention before operation	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	up to one year	80-100 cases will be enrolled to the group.