Clinical trial NCT02563366: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: 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
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Guangzhou Medical University
First posted: 2015-09-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Estimated glomerular filtration rate
timeFrame: 1 month
Secondary outcomes:
measure: Estimated glomerular filtration rate
timeFrame: 12 months
measure: Proportion of normal renal function recovery
timeFrame: 12 months
measure: Time to renal function recovery (days)
timeFrame: 12 months
measure: acute rejection rate
timeFrame: 12 months
measure: patient and graft survival rate
timeFrame: 12 months
measure: Incidence of severe adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Changxi Wang, M.D., Ph.D
role: STUDY_CHAIR
References:
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.