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Trial record 50 of 497 for:    stem cell kidney

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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ClinicalTrials.gov Identifier: NCT02490020
Recruitment Status : Unknown
Verified July 2015 by Qipeng Sun, Third Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Enrolling by invitation
First Posted : July 3, 2015
Last Update Posted : July 3, 2015
Sponsor:
Collaborators:
Zhujiang Hospital
The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Information provided by (Responsible Party):
Qipeng Sun, Third Affiliated Hospital, Sun Yat-Sen University

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.

Condition or disease Intervention/treatment Phase
Disorder Related to Renal Transplantation Renal Transplant Rejection Biological: mesenchymal stem cell Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Study Start Date : January 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: iv of BMSC to prevent rejection
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)
Biological: mesenchymal stem cell
No Intervention: routine treatment protocol to prevent rejection
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)
Experimental: ia and iv of MSC to prevent rejection
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)
Biological: mesenchymal stem cell
No Intervention: routine treatment to prevent rejection
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)
Experimental: Routine CMR treatment plus MSC to prevent CMR
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)
Biological: mesenchymal stem cell
No Intervention: Routine CMR treatment to prevent CMR
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)
Experimental: Routine AMR treatment plus MSC to prevent AMR
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)
Biological: mesenchymal stem cell
No Intervention: Routine AMR treatment to prevent AMR
Routine AMR treatment protocol(plasma exchange and IVIG as first line approach, anti-CD20 monoclonal antibody as second line approach)



Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02490020


Sponsors and Collaborators
Qipeng Sun
Zhujiang Hospital
The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Investigators
Study Director: Qiquan Sun, MD,PhD Third Affiliated Hospital, Sun Yat-Sen University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Qipeng Sun, MD, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02490020     History of Changes
Other Study ID Numbers: zssy20150624
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: July 3, 2015
Last Verified: July 2015

Keywords provided by Qipeng Sun, Third Affiliated Hospital, Sun Yat-Sen University:
Renal transplantation
mesenchymal stem cell
Transplantation Rejection
donation after cardiac death

Additional relevant MeSH terms:
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents