THIRD-PARTY BONE MARROW-DERIVED MESENCHYMAL STROMAL CELLS TO INDUCE TOLERANCE IN LIVER TRANSPLANT RECIPIENTS
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 12
- 主要终点
- Circulating naive and memory T cell conts (CD45RA/CD45RO)(flow cytometry analysis)
研究概览
简要总结
The general aim of the present study is to test a cell therapy with third-party allogeneic ex-vivo expanded MSCs as a strategy to induce tolerance in liver transplant recipients. MSCs will be prepared accordingly to established protocols , starting from diagnostic samples of bone marrow aspirates (2-5 mL) or using the remnants in the bag and filter at the end of the bone marrow infusions. From these samples, MSCs will be expanded in GMP approved facilities and used for the present study in patients undergoing liver transplantation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For this study, the following inclusion criteria should be fulfilled before starting withdrawal of drugs after 1 year post-transplant:
- •First liver transplant
- •Capable of understanding the purpose and risk of the study
- •Written informed consent
排除标准
- •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 the study protocol in the investigator's opinion.
研究组 & 干预措施
No treatment.
Mesenchymal Stromal Cells (MSC)
A single intravenous infusion (1-2 millions of MSCs per kilogram body weight) of ex-vivo expanded third-party MSC (from healthy donors) will be performed in patients assigned to the MSC procedure in addition to the liver transplantation.
干预措施: Mesenchymal Stromal Cells (Biological)
结局指标
主要结局
Circulating naive and memory T cell conts (CD45RA/CD45RO)(flow cytometry analysis)
时间窗: Changes from baseline at 6 and 12 months after transplant, then every 6 months till the first 3 years after transplant and then yearly up to 120 month.
Number of adverse events
时间窗: Changes from baseline up to 120 month.
At each visit overall clinical condition of the patient will be evaluated and any adverse event will be recorded.
Liver tissue mRNA level of Transferrin receptor CD71 (TFRC) and Hepcidin antimicrobial peptide (HAMP) genes
时间窗: At 12 and 60 month.
T-cell function in mixed lymphocyte reaction
时间窗: Changes from baseline at 6 and 12 months after transplant, then every 6 months till the first 3 years after transplant and then yearly up to 120 month.
次要结局
未报告次要终点
研究者
Monia Lorini
EC Secretary
A.O. Ospedale Papa Giovanni XXIII