Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction Between Matched Sibling Donor-recipient Pairs
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Proportion of transplanted patients who were able to discontinue immunosuppression 12 months after transplantation.
研究概览
简要总结
Combined transplantation of kidney and bone marrow between HLA-matched sibling donor-recipient pairs to induce immune tolerance in order to enable complete discontinuation of immunosuppressive therapy without kidney rejection. Hematopoietic stem cells are collected from the donor 4 to 8 weeks before kidney transplantation, CD34 cells are enriched by positive selection and cryopreserved. The day after kidney transplantation the recipient starts conditioning therapy with thymoglobuline, total lymphoid irradiation, steroids, tacrolimus and mycophenolate mofetil. Eleven days after kidney transplantation the stem cell graft is thawed and infused to the recipient. If mixed donor chimerism is successfully maintained more than 6 months without rejection, then immunosuppression may be tapered off until complete discontinuation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Age older than 18 years
- •Matched siblings
- •No contra-indication to thymoglobuline or total lymphoid irradiation
排除标准
- •Pregnant women or breast feeding
- •Infection with HIV, HBV or HCV
- •Previous or presnt malignancy
结局指标
主要结局
Proportion of transplanted patients who were able to discontinue immunosuppression 12 months after transplantation.
时间窗: 12 months
Proportion of transplanted patients who were able to discontinue immunosuppression 12 months after transplantation.
次要结局
未报告次要终点
研究者
moshe yeshurun
Dr Moshe Yeshurun, Head Bone Marrow Unit
Rabin Medical Center