Allogenic Transplantation of Ex-vivo Expanded CB Progenitors for Haematological Disorders
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- GVHD
研究概览
简要总结
The aim of this study is to evaluate the safety profile and tolerability of infusion of cord blood cells expanded in the lab and to evaluated whether through the infusion of expanded cells it is possible to expedite engraftment time after transplantation.
详细描述
Stem cell transplantation is a curative approach for patients with hematological malignancies. Umbilical cord blood is a source of stem cells for transplantation in patients with no related donor. However, in adults, the number of stem cells in a single unit, may be too low to allow engraftment, and the time to engraftment may be prolonged, increasing the risks of the transplant. In this study, we expand part of the cord blood unit, in the lab, trying to increase unit size, such that it would be suitable for adults, and would allow safe engraftment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •hematological malignancy
- •standard indication for allogeneic transplantation
- •expected survival time over 12 weeks
- •no related or unrelated donor
- •availability of a cord blood unit of compatible placental blood cryopreserved in at least 2 different bags; one of the two units should have a cellular content at least equal to the minimum dose of 2 x 107 nucleated cells per kilogram of body weight
排除标准
- •Eastern Cooperative Oncology Group (ECOG) performance status >2
- •Prior allogeneic transplantation
- •Pregnant or nursing women
- •Positive serology for hepatitis B or C
- •HIV positive
- •Left ventricular ejection fraction < 50%
- •DLCO < 50%
- •Psychiatric, addictive, or any disorder/disease which compromises ability to give informed consent for participation in this study
- •Treatment with other investigational drugs within 4 weeks of enrolling in this protocol
结局指标
主要结局
GVHD
时间窗: 1 year
Number of patients with acute and chronic GVHD after transplantation
treatment-related toxicity
时间窗: 3 months
Type and severity of adverse events after transplantation using the NCI CTC scale
Safety
时间窗: 1 month
Number of patients with adverse events during infusion
engraftment
时间窗: 3 months
Time to engraftment
次要结局
- relapse(5 years)
- Immunological reconstruction(5 years)
研究者
Dr. Avichai Shimoni MD
Dr. Avichai Shimoni, hematologist
Sheba Medical Center