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

Qipeng Sun

Status and phase: Unknown; Phase 1

Conditions: Renal Transplant Rejection; Disorder Related to Renal Transplantation

Treatments: Biological: mesenchymal stem cell

Study type: Interventional

Funder types: Other

Identifiers

NCT02490020

zssy20150624

Details and patient eligibility

About

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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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260 participants in 8 patient groups

iv of BMSC to prevent rejection

Experimental group

Description:

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)

Treatment:

Biological: mesenchymal stem cell

routine treatment protocol to prevent rejection

No Intervention group

Description:

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)

ia and iv of MSC to prevent rejection

Experimental group

Description:

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)

Treatment:

Biological: mesenchymal stem cell

routine treatment to prevent rejection

No Intervention group

Description:

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)

Routine CMR treatment plus MSC to prevent CMR

Experimental group

Description:

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)

Treatment:

Biological: mesenchymal stem cell

Routine CMR treatment to prevent CMR

No Intervention group

Description:

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)

Routine AMR treatment plus MSC to prevent AMR

Experimental group

Description:

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)

Treatment:

Biological: mesenchymal stem cell

Routine AMR treatment to prevent AMR

No Intervention group

Description:

Routine AMR treatment protocol(plasma exchange and IVIG as first line approach, anti-CD20 monoclonal antibody as second line approach)