NCT00838019Unknown4 期
Pilot Study About Viability and Efficacy of Intrabone Administration of Umbilical Cord Blood for Allogeneic Stem Cell Transplantation
适应症
干预措施
试验速览
- 阶段
- 4 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Kinetics of hematopoietic engraftment
研究概览
简要总结
The purpose of this study is to evaluate the viability of intrabone administration of umbilical cord blood as allogenic transplantation for the treatment of hematologic malignancies.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hematological malignancies
- •Indication of allogenic transplantation
- •No suitable donor (related/unrelated)
- •No suitable cord blood unit with enough cellularity for standard transplant
- •Written informed consent
排除标准
- •ECOG > 2
- •Co-morbidities
- •HIV positive serology
- •Pregnancy or breastfeeding
- •Psychiatric illness
研究组 & 干预措施
Cord blood
Experimental
干预措施: Intrabone administration of umbilical cord blood (Procedure)
结局指标
主要结局
Kinetics of hematopoietic engraftment
时间窗: days 14, 21, 28 after administration
次要结局
- Dynamics and chimerism of hematological engraftment(days 14, 21, 28 after administration)
研究者
研究点 (1)
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