Tolerance Induction in Living Donor Kidney Transplantation With Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Immune Suppression Withdrawal
研究概览
简要总结
Kidney transplantation (KT) requires a life-long immune suppression (IS). It has been well-known that long-term IS inevitably causes various complication e.g. infection, toxicity, diabetes, osteoporosis, avascular necrosis of hip joint, cataract, acne, and malignancies and so on. Tolerance induction showing graft function without maintenance IS has been considered as a final solution in the transplantation recipients. Tolerance induction can be achieved in KT recipients with donor hematopoietic stem cell transplantation (HSCT).
In this study, adult patients (18 and more years of age) with a human leukocyte antigen (HLA)-haplotype match donor are enrolled. Patients receive preconditioning treatment for HSCT 1week prior to KT. Bone marrow is harvested from donor under general anesthesia at the time of nephrectomy for transplantation in donor. Donor BM is infused immediate post-transplantation at intensive care unit (ICU). Immunologic measurements including microchimerism study and protocol biopsy will be followed at several time points. IS will be tapered slowly and withdrawn over a period of several months.
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
- •All consenting adult (18 and more years of age) living donor kidney transplant recipients who have a one haplotype match donor.
- •Patients who have no known contraindication to administration of rabbit anti-thymocyte globulin (ATG) or radiation.
- •Patients who agree to participate in the study and sign an Informed Consent.
排除标准
- •Presence of previous episode of transplantation including kidney
- •Simultaneous multi-visceral transplantation
- •Demonstration of donor specific antibody (DSA) or panel reactive antibody(PRA) greater than 20%
- •ABO blood type incompatible
- •Previous treatment with rabbit anti-thymocyte globulin or a known allergy to rabbit proteins.
- •History of malignancy with the exception of non-melanoma skin malignancies.
- •Uncontrolled systemic or concomitant unstable infection
- •Serological evidence of Hepatitis B or Hepatitis C or HIV infection.
- •Severe psychiatric disease
- •Leukopenia (with a white blood cell count < 3000/mm3)
- •Disagreement to participate in the study and sign an Informed Consent.
结局指标
主要结局
Immune Suppression Withdrawal
时间窗: Immune Suppression Withdrawal within 18 months post-transplantation
Immune suppression will be tapered-off and withdrawn over the period of 6 to 18 months post-transplantation under the monitoring of graft function and immunologic measurements.
次要结局
- Graft failure(At the post-transplantation 18 months)
- Allograft Rejection(At the post-transplantation 18 months)