NCT06715865尚未招募不适用
Clinical Study on Thymus-Kidney Transplantation From Neonatal Donors for the Induction of Immune Tolerance
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Duration of immunosuppressive therapy after surgery
研究概览
简要总结
Thymus transplantation for the induction of immune tolerance in kidney transplantation: This study aims to understand how thymus transplantation can induce immune tolerance in recipients of allogeneic kidney transplants to achieve the discontinuation of immunosuppressive therapy. It will evaluate the safety of thymus transplantation, explore the functional output of thymus tissue, investigate the optimal timing for withdrawal of immunosuppressants, and identify key indicators for the reconstruction of immune suppression capacity.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipients of both thymus and kidney transplants from the same donor.
- •Age between 18 and 65 years.
- •Non-solid organ combination transplant recipients (including heart-kidney or liver-kidney transplants, except thymus).
- •ABO blood type compatibility with the donor.
- •Negative donor-specific antibody (DSA).
- •Negative lymphocyte crossmatch (CDC).
- •Normal cardiac function (confirmed through ECG and echocardiograms).
- •Normal liver function.
- •Bodyweight between 40-100 kg (inclusive).
- •Evidence of prior epstein-barr virus (EBV) infection with positive EBV-specific immunoglobulin G (IgG) and negative immunoglobulin M (IgM).
- •Signed informed consent form.
- •Ability to adhere to regular follow-ups.
- •Normal hematopoietic function.
排除标准
- •Clinically significant genital or urinary tract dysfunction.
- •Underlying kidney diseases with a high risk of recurrence in the transplanted kidney, including:
- •a. Focal segmental glomerulosclerosis (FSGS).
- •b. Type I or II membranoproliferative glomerulonephritis.
- •c. Hemolytic uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP).
- •Any genetic mutation-associated diseases.
- •Presence of infectious diseases:
- •Strongly positive panel reactive antibodies (PRA).
- •History of receiving blood transfusion therapy.
- •Any other conditions that, in the investigator's opinion, are incompatible with participation in the trial.
研究组 & 干预措施
Thymus Transplantation Group
Experimental
干预措施: Thymus Transplantation (Procedure)
结局指标
主要结局
Duration of immunosuppressive therapy after surgery
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
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