NCT02490020

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2016

Typical duration for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 3, 2015

Status Verified

July 1, 2015

Enrollment Period

11 months

First QC Date

June 29, 2015

Last Update Submit

July 2, 2015

Conditions

Disorder Related to Renal TransplantationRenal Transplant Rejection

Keywords

Renal transplantationmesenchymal stem cellTransplantation Rejectiondonation after cardiac death

Outcome Measures

Primary Outcomes (2)

  • Numbers of participants enrolled into the MSC group and control group

    80-100 cases will be enrolled to the group.

    up to one year

  • 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.

    up to one year

Study Arms (8)

iv of BMSC to prevent rejection

EXPERIMENTAL

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

routine treatment protocol to prevent rejection

NO INTERVENTION

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

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

routine treatment to prevent rejection

NO INTERVENTION

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

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

Routine CMR treatment to prevent CMR

NO INTERVENTION

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

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

Routine AMR treatment to prevent AMR

NO INTERVENTION

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

Interventions

mesenchymal stem cellBIOLOGICAL
Routine AMR treatment plus MSC to prevent AMRRoutine CMR treatment plus MSC to prevent CMRia and iv of MSC to prevent rejectioniv of BMSC to prevent rejection

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • loss to follow-up
  • serious adverse events

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 29514693DERIVED

  • 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.

    PMID: 29145879DERIVED

Study Officials

  • Qiquan Sun, MD,PhD

    Third Affiliated Hospital, Sun Yat-Sen University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 29, 2015

First Posted

July 3, 2015

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2018

Last Updated

July 3, 2015

Record last verified: 2015-07