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Effect of BM-MSCs on Early Graft Function Recovery After DCD Kidney Transplant.

Primary Purpose

Kidney Transplantation, Acute Kidney Tubular Necrosis

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
BM-MSCs
Saline
Sponsored by
First Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Transplantation focused on measuring kidney transplantation, mesenchymal stem cell therapy, poor early graft function, delayed graft function, ischemia reperfusion injury, donation after cardiac death

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary kidney transplantation
  • Kidneys are from donation after Chinese citizen death
  • Poor early graft function with or without dialysis after transplantation
  • Patient is willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months

Exclusion Criteria:

  • Secondary kidney transplantation
  • Combined or multi-organ transplantation
  • Women who are pregnant, intend to become pregnant in the next 1 years, breastfeeding, or have a positive pregnancy test on enrollment or prior to study medication administration
  • Panel reactive antibody (PRA)>20% or CDC crossmatch is positive
  • Donors or recipients are known hepatitis C antibody-positive or polymerase chain reaction (PCR) positive for hepatitis C
  • Donors or recipients are known hepatitis B surface antigen-positive or PCR positive for hepatitis B
  • Donors or recipients are known human immunodeficiency virus (HIV) infection
  • Patients with active infection
  • Recipients with a history of substance abuse (drugs or alcohol) within the past 6 months, or psychotic disorders that are not capable with adequate study follow- up.
  • Patients with severe cardiovascular dysfunction
  • WBC<3*10^9/L or RBC <5g/dL
  • Highly allergic constitution or having severe history of allergies.
  • Patients with active peptic ulcer disease, chronic diarrhea, or gastrointestinal problem affect absorption
  • Patients with a history of cancer within the last 5 years
  • Prisoner or patients compulsorily detained (involuntarily incarcerated) for treatment or either a psychiatric or physical (e.g. infectious disease) illness

Sites / Locations

  • The First Affiliated Hospital, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MSCs group

Control group

Arm Description

Patients with early poor graft function receive allogeneic BM-MSCs at the dose of 1*10^6/kg every week for four consecutive doses.

Patients with early poor graft function receive placebo of MSCs, i.e. saline every week for four consecutive doses.

Outcomes

Primary Outcome Measures

Estimated glomerular filtration rate
eGFR at one month post transplant

Secondary Outcome Measures

Estimated glomerular filtration rate
eGFR up to 12 months post transplant
Proportion of normal renal function recovery
Time to renal function recovery (days)
acute rejection rate
Acute rejection rate according to Banff 2013 criteria up to 12 months post transplant
patient and graft survival rate
patient and graft survival rate up to 12 months post transplantation
Incidence of severe adverse events
Incidence of severe adverse events up to 12 months post transplantation

Full Information

First Posted
September 26, 2015
Last Updated
September 28, 2015
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
Collaborators
Second Affiliated Hospital of Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02563366
Brief Title
Effect of BM-MSCs on Early Graft Function Recovery After DCD Kidney Transplant.
Official Title
Effect of Bone Marrow-derived Mesenchymal Stem Cells (BM-MSCs) on Recovery of Poor Early Graft Function Post Kidney Transplantation From Chinese Donation After Citizen Death (DCD): A Multi-center Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University
Collaborators
Second Affiliated Hospital of Guangzhou Medical University

4. Oversight

5. Study Description

Brief Summary
This study is designed to investigate whether allogeneic bone marrow-derived mesenchymal stem cells (BM-MSCs) can promote function recovery in patients with poor early graft function after kidney transplantation from Chinese Donation after Citizen Death (DCD). DCD kidney transplant recipients with poor early graft function (with or without dialysis) post transplant are equally randomized into MSCs group or control group. Patients in MSCs group are administered MSCs treatment. Allogeneic BM-MSCs (1*10^6/kg) from third party are given intravenously for four consecutive doses every week after enrollment. Patients in control group receive placebo. Renal allograft function (eGFR), rejection, patient/graft survival and severe adverse events up to 12 months post enrollment are monitored.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation, Acute Kidney Tubular Necrosis
Keywords
kidney transplantation, mesenchymal stem cell therapy, poor early graft function, delayed graft function, ischemia reperfusion injury, donation after cardiac death

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MSCs group
Arm Type
Experimental
Arm Description
Patients with early poor graft function receive allogeneic BM-MSCs at the dose of 1*10^6/kg every week for four consecutive doses.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients with early poor graft function receive placebo of MSCs, i.e. saline every week for four consecutive doses.
Intervention Type
Other
Intervention Name(s)
BM-MSCs
Other Intervention Name(s)
allogeneic bone marrow-derived MSCs
Intervention Description
BM-MSCs are from third-party healthy volunteer donors.
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
Saline is the placebo of MSCs in this study.
Primary Outcome Measure Information:
Title
Estimated glomerular filtration rate
Description
eGFR at one month post transplant
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Estimated glomerular filtration rate
Description
eGFR up to 12 months post transplant
Time Frame
12 months
Title
Proportion of normal renal function recovery
Time Frame
12 months
Title
Time to renal function recovery (days)
Time Frame
12 months
Title
acute rejection rate
Description
Acute rejection rate according to Banff 2013 criteria up to 12 months post transplant
Time Frame
12 months
Title
patient and graft survival rate
Description
patient and graft survival rate up to 12 months post transplantation
Time Frame
12 months
Title
Incidence of severe adverse events
Description
Incidence of severe adverse events up to 12 months post transplantation
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary kidney transplantation Kidneys are from donation after Chinese citizen death Poor early graft function with or without dialysis after transplantation Patient is willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months Exclusion Criteria: Secondary kidney transplantation Combined or multi-organ transplantation Women who are pregnant, intend to become pregnant in the next 1 years, breastfeeding, or have a positive pregnancy test on enrollment or prior to study medication administration Panel reactive antibody (PRA)>20% or CDC crossmatch is positive Donors or recipients are known hepatitis C antibody-positive or polymerase chain reaction (PCR) positive for hepatitis C Donors or recipients are known hepatitis B surface antigen-positive or PCR positive for hepatitis B Donors or recipients are known human immunodeficiency virus (HIV) infection Patients with active infection Recipients with a history of substance abuse (drugs or alcohol) within the past 6 months, or psychotic disorders that are not capable with adequate study follow- up. Patients with severe cardiovascular dysfunction WBC<3*10^9/L or RBC <5g/dL Highly allergic constitution or having severe history of allergies. Patients with active peptic ulcer disease, chronic diarrhea, or gastrointestinal problem affect absorption Patients with a history of cancer within the last 5 years Prisoner or patients compulsorily detained (involuntarily incarcerated) for treatment or either a psychiatric or physical (e.g. infectious disease) illness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Changxi Wang, M.D., Ph.D
Phone
86-20-87333428
Email
wangchx@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Longshan Liu, M.D., Ph.D
Phone
86-20-87306082
Email
liulshan@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changxi Wang, M.D., Ph.D
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changxi Wang, M.D., Ph.D
Phone
86-20-87333428
Email
wangchx@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Longshan Liu, M.D., Ph.D
Phone
86-20-87306082
Email
liulshan@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Changxi Wang, M.D., Ph.D

12. IPD Sharing Statement

Citations:
PubMed Identifier
23263506
Citation
Peng Y, Ke M, Xu L, Liu L, Chen X, Xia W, Li X, Chen Z, Ma J, Liao D, Li G, Fang J, Pan G, Xiang AP. Donor-derived mesenchymal stem cells combined with low-dose tacrolimus prevent acute rejection after renal transplantation: a clinical pilot study. Transplantation. 2013 Jan 15;95(1):161-8. doi: 10.1097/TP.0b013e3182754c53. Erratum In: Transplantation. 2014 Mar 27;97(6):e37. Pan, Guanghui [added].
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/23263506
Description
Previous publication

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Effect of BM-MSCs on Early Graft Function Recovery After DCD Kidney Transplant.

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