Non-interventional Single-center Study of the Contribution of DP8α Regulatory T Cells Induced by a Gut Microbiota Bacterium to Kidney Transplant Tolerance.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- To test the role of donor-specific DP8α Tregs in preventing kidney transplant rejection.
研究概览
简要总结
Prospective experimental study using PBMC from a limited number of adult patients (15) treated at Nantes University Hospital for a kidney transplant from a related living donor.
The study will be carried out on PBMC from both donors and recipients, collected during visits scheduled as part of the clinical management of the donor/recipient pair.
The study will test the hypothesis that DP8α Tregs expressing CD73, whose frequency in blood increases stably after non-rejected kidney transplants, but not when patients have undergone or will subsequently undergo rejection, are enriched in donor-specific cells, which would be a strong argument in favor of a direct role for these Tregs in preventing transplant rejection, through their ability to inhibit immune responses directed against donor alloantigens.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Adult donor-recipient pair.
- •First or second kidney transplant from a related ABO-compatible living donor.
- •BMI < 35 for recipients.
- •Adult patients.
- •Patients weighing over 50 kgs.
排除标准
- •Donor/recipient ABO incompatibility
- •BMI > 35 for recipients
结局指标
主要结局
To test the role of donor-specific DP8α Tregs in preventing kidney transplant rejection.
时间窗: 3 months
Measurement at D0 and 3 months post-transplant, and comparison, of the frequency of DP8a Tregs expressing CD73 among circulating T lymphocytes and the frequency of donor-reactive DP8a Tregs (identified in culture by their proliferative response to donor monocytes and clonal validation of DP8a Treg anti-donor reactivity at the 3-month post-transplant stage.
次要结局
- Determine whether the increased anti-donor reactivity of the patient's DP8α Tregs after transplantation results from the amplification among them of clones and establish, if possible, the anti-donor reactivity of amplified clones.(3 months)
- Determine whether clones of DP8α Tregs (reactive or not to donor antigens) are reactive to F. prausnitzii bacteria.(3 months)