Autologous Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Antibody Mediated Kidney Graft Rejection (ABMR)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Safety of MSC transplantation as assessed by adverse events according to CTCAE Version 5Estimated glomerular filtration rate (eGFR)
研究概览
简要总结
Transplant rejection is one of the biggest limitations in renal transplant procedures, where the kidney can undergo an acute, late acute, or chronic transplant rejection. With the advancement in transplantation protocols, acute survival of renal transplants has improved, but long-term survival is still unsatisfactory, as most of the renal transplants develop chronic graft rejection. Unfortunately, there is little the investigators know when it comes to improving long-term survival of renal transplants. Mesenchymal stem cells (MSC) have been shown to have immunosuppressive and repairing properties. The purpose of this study is to find out whether MSC in combination with standard therapy of antibody mediated rejection (ABMR) are more effective in preventing organ deterioration and maintaining kidney function.
详细描述
Participants will be assigned to receive the full immunosuppressive therapy indicated to treat chronic ABMR (including plasmapheresis (PF) 7x, intravenous immune globulins 100 mg/kg 7x, corticosteroid) and MSC infusions (2x106cells/kg bw after PF) (Group 1) and be compared to historic controls according to "propensity score matching" (treated with immunosuppressive therapy alone (Group 2)). Patients will undergo MSC infusions at the start of the study after each PF. One year post- infusions, patients will be evaluated and undergo kidney biopsies. Blood collection will occur at regular intervals, serum creatinine and the estimated creatinine clearance will be monthly recorded. The transplanted kidney function and morphology (US Doppler) will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipients of a renal allograft, male and female patients age >18
- •The eGF>20 ml/min/1.73 m2,
- •Renal biopsy Criteria: chronic active ABMR.
- •Written informed consent, compliant with local regulations.
排除标准
- •Recipients of multiple organs.
- •Pregnant women.
- •Malignant disease in last 5 years
- •Active autoimmune disease
- •Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis
- •Evidence of congestive cardiac failure and/or acute coronary syndrome in past 6 months.
- •Evidence of liver disease
- •Inadequate compliance to treatment.
研究组 & 干预措施
Historic control
historic cohort of patients with ABMR treated with standard of care therapy
MSC transplantation
patients with ABMR treated with MSC transplantation
干预措施: MSC transplantation (Other)
结局指标
主要结局
Safety of MSC transplantation as assessed by adverse events according to CTCAE Version 5Estimated glomerular filtration rate (eGFR)
时间窗: 12 months
Adverse events according to CTCAE Version 5
次要结局
- Estimated glomerular filtration rate (eGFR)(12 months)
- Graft survival rate(12 months)
研究者
Veceric-Haler Zeljka
Principal investigator
University Medical Centre Ljubljana