Third-party Bone Marrow-derived Mesenchymal Stromal Cells to Induce Tolerance in Recipients of Kidney Transplants From Deceased Donors (Phase A)
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Number of adverse events
研究概览
简要总结
The general aim of the present study is to test a cell therapy with third-party ex-vivo expanded bone marrow-derived mesenchymal stromal cells (MSCs) as a strategy to induce tolerance in kidney transplant recipients with a deceased donor. MSCs will be prepared accordingly to established protocols, starting from the remnants in the bag and filter at the end of the bone marrow infusions. 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.
The proposed study will be developed in two phases: i) a pilot explorative safety/biologic-mechanistic phase (Phase A), ii) a pilot efficacy phase (Phase B).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First single kidney transplant;
- •Capable of understanding the purpose and risk of the study;
- •Written informed consent.
排除标准
- •PRA >10%;
- •Specific contraindication to MSC infusion;
- •Any clinical relevant condition that might affect study participation and/or study results;
- •Childbearing potential without effective contraception;
- •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
Number of adverse events
时间窗: Changes from baseline through study completion, up to 12 months after transplant.
At each visit overall clinical condition of the patient will be evaluated and any adverse event will be recorded.
Circulating naive and memory T cell count (CD45RA/CD45RO) (flow cytometry analysis)
时间窗: Changes from baseline at 7, 14, 30 days after transplant and then every six months through study completion, up to 12 months after transplant.
Circulating regulatory T cell count.
时间窗: Changes from baseline at 7, 14, 30 days after transplant and then every six months through study completion, up to 12 months after transplant.
T-cell function in mixed lymphocyte reaction.
时间窗: Changes from baseline at 6 and 12 months after transplant.
IFNg-producing T cells (spots/300.000 cells) and CD8+ T cell-mediated cytotoxicity (percentage of specific lysis) will be measured in mixed lymphocyte reaction.
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
研究者
Monia Lorini
EC Secretary
A.O. Ospedale Papa Giovanni XXIII