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

Sun Yat-sen University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Acute Kidney Tubular Necrosis; Kidney Transplantation

Treatments: Other: BM-MSCs; Other: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02563366

MSCs-KTx-DCD-150925

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups, including a placebo group

MSCs group

Experimental group

Description:

Patients with early poor graft function receive allogeneic BM-MSCs at the dose of 1\*10\^6/kg every week for four consecutive doses.

Treatment:

Other: BM-MSCs

Control group

Placebo Comparator group

Description:

Patients with early poor graft function receive placebo of MSCs, i.e. saline every week for four consecutive doses.

Treatment:

Other: Saline