The Efficacy and Safety of Bone Marrow-derived Mesenchymal Stem Cells in 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 determine the efficacy and safety of allogeneic bone marrow-derived mesenchymal stem cells in kidney transplantation from Chinese donation after citizen's death (DCD). A pair uremia patients receiving kidney grafts from a same donor are randomized into two groups: MSCs group and control group. Besides routine induction therapy (ATG or Basiliximab) and maintenance immunosuppressive drugs (low-dose Tacrolimus + MPA + prednisone), patients in MSCs group are administered MSCs treatment (1*10^6/kg). Allogeneic bone marrow-derived MSCs (1*10^6/kg) are given intravenously at day 0 (post renal reperfusion during surgery), day 7, day 14 and day 21. The renal allograft function, rejection, patient/graft survival and severe adverse events within 12 months post-transplant 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
- •Receiving induction therapy and combined immunosuppressive regimens (CNIs + MPA + steroids)
- •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%
- •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
研究组 & 干预措施
MSCs group
Allogeneic bone marrow-derived mesenchymal stem cells (10^6/kg) from third party donors is intravenously given at day 0 (after renal artery reperfusion), day 7, day 14 and day 21.Induction therapy: ATG or Basiliximab; Maintenance therapy: low-dose Tacrolimus + mycophenolic acid + prednisone.
The third-party MSCs have no similar HLA alleles of kidney donors, and have no HLA alleles specific to preformed anti-HLA antibodies in recipients prior to KTx.
干预措施: bone marrow-derived mesenchymal stem cells (Other)
MSCs group
Allogeneic bone marrow-derived mesenchymal stem cells (10^6/kg) from third party donors is intravenously given at day 0 (after renal artery reperfusion), day 7, day 14 and day 21.Induction therapy: ATG or Basiliximab; Maintenance therapy: low-dose Tacrolimus + mycophenolic acid + prednisone.
The third-party MSCs have no similar HLA alleles of kidney donors, and have no HLA alleles specific to preformed anti-HLA antibodies in recipients prior to KTx.
干预措施: Induction therapy (ATG or Basiliximab) (Drug)
MSCs group
Allogeneic bone marrow-derived mesenchymal stem cells (10^6/kg) from third party donors is intravenously given at day 0 (after renal artery reperfusion), day 7, day 14 and day 21.Induction therapy: ATG or Basiliximab; Maintenance therapy: low-dose Tacrolimus + mycophenolic acid + prednisone.
The third-party MSCs have no similar HLA alleles of kidney donors, and have no HLA alleles specific to preformed anti-HLA antibodies in recipients prior to KTx.
干预措施: Maintenance therapy (Low-dose CNI + MPA + steroids) (Drug)
Control group
Placebo (saline) is intravenously given at day 0 (after renal artery reperfusion), day 7, day 14 and day 21. Induction therapy: ATG or Basiliximab; Maintenance therapy: low-dose Tacrolimus + mycophenolic acid + prednisone.
干预措施: Saline (Other)
Control group
Placebo (saline) is intravenously given at day 0 (after renal artery reperfusion), day 7, day 14 and day 21. Induction therapy: ATG or Basiliximab; Maintenance therapy: low-dose Tacrolimus + mycophenolic acid + prednisone.
干预措施: Induction therapy (ATG or Basiliximab) (Drug)
Control group
Placebo (saline) is intravenously given at day 0 (after renal artery reperfusion), day 7, day 14 and day 21. Induction therapy: ATG or Basiliximab; Maintenance therapy: low-dose Tacrolimus + mycophenolic acid + prednisone.
干预措施: Maintenance therapy (Low-dose CNI + MPA + steroids) (Drug)
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
- Incidence of slow graft function(12 months)
- Patient survival(12 months)
- Incidence of acute rejection(12 months)
- Incidence of delayed graft function(12 months)
- Proportion of normal renal function recovery(12 months)
- Time to renal function recovery(12 months)
- Renal graft survival(12 months)
- Severe adverse events(12 months)
- Estimated glomerular filtration rate(12 months)
研究者
Changxi Wang
Director of Organ Transplant Center
First Affiliated Hospital, Sun Yat-Sen University