Effect of BM-MSCs on Early Graft Function Recovery After DCD Kidney Transplant.
NCT ID: NCT02563366
Last Updated: 2015-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
120 participants
INTERVENTIONAL
2015-11-30
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
BM-MSCs
BM-MSCs are from third-party healthy volunteer donors.
Control group
Patients with early poor graft function receive placebo of MSCs, i.e. saline every week for four consecutive doses.
Saline
Saline is the placebo of MSCs in this study.
Interventions
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BM-MSCs
BM-MSCs are from third-party healthy volunteer donors.
Saline
Saline is the placebo of MSCs in this study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Second Affiliated Hospital of Guangzhou Medical University
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Changxi Wang
Director of Organ Transplant Center
Principal Investigators
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Changxi Wang, M.D., Ph.D
Role: STUDY_CHAIR
First Affiliated Hospital, Sun Yat-Sen University
Locations
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The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Changxi Wang, M.D., Ph.D
Role: primary
Longshan Liu, M.D., Ph.D
Role: backup
References
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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.
Related Links
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Previous publication
Other Identifiers
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MSCs-KTx-DCD-150925
Identifier Type: -
Identifier Source: org_study_id