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

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ClinicalTrials.gov Identifier: NCT02563366
Recruitment Status : Unknown
Verified September 2015 by Changxi Wang, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Not yet recruiting
First Posted : September 30, 2015
Last Update Posted : September 30, 2015
Sponsor:
Collaborator:
Second Affiliated Hospital of Guangzhou Medical University
Information provided by (Responsible Party):
Changxi Wang, First Affiliated Hospital, Sun Yat-Sen University

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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Acute Kidney Tubular Necrosis Other: BM-MSCs Other: Saline Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : November 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Estimated glomerular filtration rate [ Time Frame: 1 month ]
    eGFR at one month post transplant


Secondary Outcome Measures :
  1. Estimated glomerular filtration rate [ Time Frame: 12 months ]
    eGFR up to 12 months post transplant

  2. Proportion of normal renal function recovery [ Time Frame: 12 months ]
  3. Time to renal function recovery (days) [ Time Frame: 12 months ]
  4. acute rejection rate [ Time Frame: 12 months ]
    Acute rejection rate according to Banff 2013 criteria up to 12 months post transplant

  5. patient and graft survival rate [ Time Frame: 12 months ]
    patient and graft survival rate up to 12 months post transplantation

  6. Incidence of severe adverse events [ Time Frame: 12 months ]
    Incidence of severe adverse events up to 12 months post transplantation



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02563366


Contacts
Contact: Changxi Wang, M.D., Ph.D 86-20-87333428 wangchx@mail.sysu.edu.cn
Contact: Longshan Liu, M.D., Ph.D 86-20-87306082 liulshan@mail.sysu.edu.cn

Locations
China, Guangdong
The First Affiliated Hospital, Sun Yat-sen University Not yet recruiting
Guangzhou, Guangdong, China, 510080
Contact: Changxi Wang, M.D., Ph.D    86-20-87333428    wangchx@mail.sysu.edu.cn   
Contact: Longshan Liu, M.D., Ph.D    86-20-87306082    liulshan@mail.sysu.edu.cn   
Principal Investigator: Changxi Wang, M.D., Ph.D         
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Second Affiliated Hospital of Guangzhou Medical University
Investigators
Study Chair: Changxi Wang, M.D., Ph.D First Affiliated Hospital, Sun Yat-Sen University

Additional Information:
Publications:
Responsible Party: Changxi Wang, Director of Organ Transplant Center, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02563366     History of Changes
Other Study ID Numbers: MSCs-KTx-DCD-150925
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015

Keywords provided by Changxi Wang, First Affiliated Hospital, Sun Yat-Sen University:
kidney transplantation
mesenchymal stem cell therapy
poor early graft function
delayed graft function
ischemia reperfusion injury
donation after cardiac death

Additional relevant MeSH terms:
Necrosis
Kidney Tubular Necrosis, Acute
Pathologic Processes
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases