Effect of BM-MSCs on Early Graft Function Recovery After DCD Kidney Transplant.
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
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2015
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2015
CompletedFirst Posted
Study publicly available on registry
September 30, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedSeptember 30, 2015
September 1, 2015
1.9 years
September 26, 2015
September 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Estimated glomerular filtration rate
eGFR at one month post transplant
1 month
Secondary Outcomes (6)
Estimated glomerular filtration rate
12 months
Proportion of normal renal function recovery
12 months
Time to renal function recovery (days)
12 months
acute rejection rate
12 months
patient and graft survival rate
12 months
- +1 more secondary outcomes
Study Arms (2)
MSCs group
EXPERIMENTALPatients with early poor graft function receive allogeneic BM-MSCs at the dose of 1\*10\^6/kg every week for four consecutive doses.
Control group
PLACEBO COMPARATORPatients with early poor graft function receive placebo of MSCs, i.e. saline every week for four consecutive doses.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Related Publications (1)
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.
PMID: 23263506BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Changxi Wang, M.D., Ph.D
First Affiliated Hospital, Sun Yat-Sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Organ Transplant Center
Study Record Dates
First Submitted
September 26, 2015
First Posted
September 30, 2015
Study Start
November 1, 2015
Primary Completion
October 1, 2017
Study Completion
December 1, 2017
Last Updated
September 30, 2015
Record last verified: 2015-09