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

Phase 1

• Conditions: Acute Kidney Tubular Necrosis; Kidney Transplantation
• Interventions: Other: Saline; Other: BM-MSCs

• Registration Number: NCT02563366
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-09
• Study First Submitted: 2015-09-26
• Study First Submitted QC: 2015-09-28
• Last Update Submitted: 2015-09-28
• Study First Posted: 2015-09-30
• Last Update Posted: 2015-09-30
• Study Start: 2015-11
• Primary Completion: 2017-10
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Saline	Patients with early poor graft function receive placebo of MSCs, i.e. saline every week for four consecutive doses.
MSCs group	BM-MSCs	Patients with early poor graft function receive allogeneic BM-MSCs at the dose of 1\*10\^6/kg every week for four consecutive doses.

Primary Outcome Measures

Name	Time	Method
Estimated glomerular filtration rate	1 month	eGFR at one month post transplant

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China