NCT00151164终止2 期
Thymic Tolerance in Pediatric Heart Transplantation
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Determine if intra-thymic inoculation of donor bone marrow cells at time of heart transplantation in children will reduce frequency of acute rejection as well as long-term requirements of immunosuppressive medications when compared to control patients
研究概览
简要总结
The investigators hypothesize that injecting donor bone marrow cells into the recipient thymus gland at the time of heart transplantation in children will prove to be feasible and safe. They further hypothesize that recipients receiving donor bone marrow will experience less acute rejection events with reduced long-term requirements for immunosuppressive medications when compared to controls who do not receive marrow but who are managed under an identical immunosuppressive protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 1 Day 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Less than 21 years of age at listing
- •Listed for primary orthotopic heart transplant at Children's Hospital of Pittsburgh, between 04/01/04 and 03/31/08
排除标准
- •History of prior transplant
- •Listed for multi-organ transplant
- •Sensitized against human HLA tissue types
- •Documentation of total thymomectomy during a prior surgery
结局指标
主要结局
Determine if intra-thymic inoculation of donor bone marrow cells at time of heart transplantation in children will reduce frequency of acute rejection as well as long-term requirements of immunosuppressive medications when compared to control patients
次要结局
- Compare results of serial in vitro immunological monitoring among patients receiving intra-thymic bone marrow and controls
研究者
研究点 (2)
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