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

Primary Purpose

Disorder Related to Renal Transplantation, Renal Transplant Rejection

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
mesenchymal stem cell
Sponsored by
Qipeng Sun
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Disorder Related to Renal Transplantation focused on measuring Renal transplantation, mesenchymal stem cell, Transplantation Rejection, donation after cardiac death

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm Type

    Experimental

    No Intervention

    Experimental

    No Intervention

    Experimental

    No Intervention

    Experimental

    No Intervention

    Arm Label

    iv of BMSC to prevent rejection

    routine treatment protocol to prevent rejection

    ia and iv of MSC to prevent rejection

    routine treatment to prevent rejection

    Routine CMR treatment plus MSC to prevent CMR

    Routine CMR treatment to prevent CMR

    Routine AMR treatment plus MSC to prevent AMR

    Routine AMR treatment to prevent AMR

    Arm 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)

    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 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 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 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)

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

    Outcomes

    Primary Outcome Measures

    Numbers of participants enrolled into the MSC group and control group
    80-100 cases will be enrolled to the group.
    Incident rates of BPAR and DGF after renal transplantation with MSC prevention before operation
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 29, 2015
    Last Updated
    July 2, 2015
    Sponsor
    Qipeng Sun
    Collaborators
    Zhujiang Hospital, The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02490020
    Brief Title
    A Perspective Multicenter Controlled Study On Application Of Mesenchymal Stem Cell(MSC) To Prevent Rejection After Renal Transplantation By Donation After Cardiac Death
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Qipeng Sun
    Collaborators
    Zhujiang Hospital, The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Disorder Related to Renal Transplantation, Renal Transplant Rejection
    Keywords
    Renal transplantation, mesenchymal stem cell, Transplantation Rejection, donation after cardiac death

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    260 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    iv of BMSC to prevent rejection
    Arm Type
    Experimental
    Arm 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)
    Arm Title
    routine treatment protocol to prevent rejection
    Arm Type
    No Intervention
    Arm 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)
    Arm Title
    ia and iv of MSC to prevent rejection
    Arm Type
    Experimental
    Arm 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)
    Arm Title
    routine treatment to prevent rejection
    Arm Type
    No Intervention
    Arm 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)
    Arm Title
    Routine CMR treatment plus MSC to prevent CMR
    Arm Type
    Experimental
    Arm 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)
    Arm Title
    Routine CMR treatment to prevent CMR
    Arm Type
    No Intervention
    Arm 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)
    Arm Title
    Routine AMR treatment plus MSC to prevent AMR
    Arm Type
    Experimental
    Arm 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)
    Arm Title
    Routine AMR treatment to prevent AMR
    Arm Type
    No Intervention
    Arm Description
    Routine AMR treatment protocol(plasma exchange and IVIG as first line approach, anti-CD20 monoclonal antibody as second line approach)
    Intervention Type
    Biological
    Intervention Name(s)
    mesenchymal stem cell
    Primary Outcome Measure Information:
    Title
    Numbers of participants enrolled into the MSC group and control group
    Description
    80-100 cases will be enrolled to the group.
    Time Frame
    up to one year
    Title
    Incident rates of BPAR and DGF after renal transplantation with MSC prevention before operation
    Description
    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.
    Time Frame
    up to one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 BPAR having no contraindication of renal biopsy signed informed consent Exclusion Criteria: loss to follow-up serious adverse events
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Qiquan Sun, MD,PhD
    Organizational Affiliation
    Third Affiliated Hospital, Sun Yat-Sen University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29514693
    Citation
    Sun Q, Huang Z, Han F, Zhao M, Cao R, Zhao D, Hong L, Na N, Li H, Miao B, Hu J, Meng F, Peng Y, Sun Q. Allogeneic mesenchymal stem cells as induction therapy are safe and feasible in renal allografts: pilot results of a multicenter randomized controlled trial. J Transl Med. 2018 Mar 7;16(1):52. doi: 10.1186/s12967-018-1422-x.
    Results Reference
    derived
    PubMed Identifier
    29145879
    Citation
    Sun Q, Hong L, Huang Z, Na N, Hua X, Peng Y, Zhao M, Cao R, Sun Q. Allogeneic mesenchymal stem cell as induction therapy to prevent both delayed graft function and acute rejection in deceased donor renal transplantation: study protocol for a randomized controlled trial. Trials. 2017 Nov 16;18(1):545. doi: 10.1186/s13063-017-2291-y.
    Results Reference
    derived

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

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