Autologous Bone Marrow Mesenchymal Stem Cell Transplantation in Recipients of Living Kidney Allografts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Incidence rate of biopsy-proven acute rejection and early renal function recovery
研究概览
简要总结
The goal of this study is to evaluate autologous MSCs as an alternative for antibody induction therapy in renal transplantation.
详细描述
Renal transplantation is the most common and successful type of organ transplantation. Induction therapy with antibody plus the maintenance immunosuppressive agents have greatly improved graft survival in renal transplantation. Since mesenchymal stem cells(MSCs)have been used successfully to treat graft versus host disease and show immune modulation function both in vitro and in vivo and may help in repairing damaged tissue(s), we evaluate autologous MSCs as an alternative for antibody induction therapy. Moreover, we examine if MSCs could improve the recovery of early function in transplanted kidney.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be between the ages of 18 and 60 years and meet the institution's criteria for renal transplantation for end-stage renal failure
- •Patient is receiving the first renal transplant
- •Patient is receiving a renal transplant only
- •Women who are of child bearing potential must have a negative pregnancy test (urine test is acceptable) and agree to use reliable contraception for 1 year following transplant
- •Willing to comply with the study visits
- •Be able to sign informed consent document.
- •Note: The subjects do not need to be local residents in order to be eligible for this trial, but must be willing to reside in the area, or within a four hour drive, for the first three months of the protocol so that we can monitor them closely in the early post transplant period.
排除标准
- •Previously received or is receiving an organ transplant other than a kidney
- •Significant liver disease, defined as having continuously elevated AST (SGOT) or ALT (SGPT) levels greater than 3 times the upper value of the normal range within 28 days prior to study entry
- •HIV infection.
- •Surface antigen positive for HBV.
- •Antibody positive for hepatitis C virus
- •Recipient or donor is positive for tuberculosis (TB), under treatment for suspected TB, or previously exposed to TB
- •Currently receiving an investigational drug or received an investigational drug within 30 days prior to transplant.
- •Currently receiving any immunosuppressive agent.
- •Clinically active bacterial, fungal, viral or parasitic infection
- •Evidence for immunologic memory against donor.
- •Recipients need antibody induction treatment before the operation.
- •Current cancer or a history of cancer within the 5 years prior to study entry.
- •Serious heart and lung diseases.
- •Patients who's RPR is positive
- •Pregnancy or breastfeeding.
- •Have no ability to communicate.
- •Any form of substance abuse, psychiatric disorder, or other condition that, in opinion of the investigator, may interfere with the study
结局指标
主要结局
Incidence rate of biopsy-proven acute rejection and early renal function recovery
时间窗: At 1 year post-transplant
次要结局
- Patient and graft survival and prevalence of adverse events(At 1 year post-transplant)