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

September 28, 2015 updated by: Changxi Wang, First Affiliated Hospital, Sun Yat-Sen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital, Sun Yat-sen University
        • Principal Investigator:
          • Changxi Wang, M.D., Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MSCs group
Patients with early poor graft function receive allogeneic BM-MSCs at the dose of 1*10^6/kg every week for four consecutive doses.
Other: BM-MSCs
BM-MSCs are from third-party healthy volunteer donors.
Other Names:
  • allogeneic bone marrow-derived MSCs
Placebo Comparator: Control group
Patients with early poor graft function receive placebo of MSCs, i.e. saline every week for four consecutive doses.
Other: Saline
Saline is the placebo of MSCs in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated glomerular filtration rate
Time Frame: 1 month
eGFR at one month post transplant
1 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Collaborators

Second Affiliated Hospital of Guangzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 26, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (Estimate)

September 30, 2015

Study Record Updates

Last Update Posted (Estimate)

September 30, 2015

Last Update Submitted That Met QC Criteria

September 28, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSCs-KTx-DCD-150925

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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