Autologous Mesenchymal Stromal Cells to Induce Tolerance in Living-donor Kidney Transplant Recipients
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- T-cell function by ELISPOT assay in mixed lymphocyte reaction.
研究概览
简要总结
The general aim of the present study is to test a cell therapy with autologous ex-vivo expanded mesenchymal stromal cells (MSCs) as a strategy to induce tolerance in living-donor kidney transplant recipients. MSCs will be prepared accordingly to established protocols, starting from bone marrow explants of living-donor kidney transplant recipients obtained 3-4 months before kidney transplant. From these samples, MSCs will be expanded in Good Manufacturing Practice (GMP) approved facilities and used for the present study in patients undergoing kidney transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male and female patients;
- •Aged 18 or older;
- •Living-donor (related and unrelated, spouse/husband) kidney transplant recipients;
- •Non-Human Leukocyte Antigen (HLA) identical with the donor (one or two haplotype mismatches);
- •First kidney transplant;
- •Capable of understanding the purpose and risk of the study;
- •Written informed consent.
排除标准
- •MSC donor positive for HIV-1, HIV-2, hepatitis B virus (HBV),hepatitis C virus (HCV), syphilis;
- •Specific contraindication to MSC infusion;
- •Any clinical relevant condition that might affect study participation and/or study results;
- •Pregnant women and nursing mothers;
- •Unwillingness or inability to follow study protocol in the investigator's opinion.
结局指标
主要结局
T-cell function by ELISPOT assay in mixed lymphocyte reaction.
时间窗: Changes from baseline at 6 and 12 months after transplant.
Circulating naïve and memory T cell count (CD45RA/CD45RO) (flow cytometry analysis).
时间窗: Changes from baseline at 6 and 12 months after transplant.
Number of adverse events.
时间窗: Changes from baseline up to 48 months.
At each visit the overall clinical condition of the patient will be evaluated and any adverse event will be recorded.
Circulating regulatory T cell count.
时间窗: Changes from baseline at 6 and 12 months after transplant.
Urinary FOXP3 mRNA expression evaluated by real time quantitative PCR.
时间窗: Changes from baseline at 6 and 12 months after transplant.
次要结局
未报告次要终点