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
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Estimated glomerular filtration rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Estimated glomerular filtration rate
时间窗: 1 month
eGFR at one month post transplant
次要结局
- acute rejection rate(12 months)
- Incidence of severe adverse events(12 months)
- Proportion of normal renal function recovery(12 months)
- Estimated glomerular filtration rate(12 months)
- patient and graft survival rate(12 months)
- Time to renal function recovery (days)(12 months)
研究者
Changxi Wang
Director of Organ Transplant Center
First Affiliated Hospital, Sun Yat-Sen University