Compassionate Access of the Miltenyi Device for CD34+ Cell Selection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Increased Graft Function after Stem Cell Transplantation (SCT)
研究概览
简要总结
Objectives:
Primary Objective
To provide compassionate access to the Miltenyi device for CD34+ cell infusions to patients who experience poor graft function after stem cell transplantation (SCT).
详细描述
The therapy that you will receive involves you being given an infusion of CD34 positive stem cells.
Below is a detailed explanation of the therapeutic procedures that will be performed.
CD34 positive stem cells infusion:
The CD34 positive stem cells are collected from a donor's blood. The blood cells go through CD34 (stem cell) selection process that collects the stem cells that are needed for the infusion. This process collects the early immune cells your body will need to regrow your immune system, and makes sure that other cells will not be infused. This process will decrease (but not eliminate completely) the other types of cells. If you agree to receive this treatment, the CD34 cells will then be infused into your body.
The CD34 positive cells will be given by vein in either an inpatient or outpatient treatment area. The infusion will last about 10-30 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) Patients who have poor or no graft function post stem cell transplantation.
排除标准
- 未提供
研究组 & 干预措施
CD34 Positive Stem Cell Infusion
Participants infused by vein with around 1 - 4 million/kg CD34+ selected cells. If the first infusion is not effective, an additional infusion may be given 4 - 6 weeks after the first infusion.
干预措施: CD34 Positive Stem Cell Infusion (Biological)
CD34 Positive Stem Cell Infusion
Participants infused by vein with around 1 - 4 million/kg CD34+ selected cells. If the first infusion is not effective, an additional infusion may be given 4 - 6 weeks after the first infusion.
干预措施: Miltenyi device (Device)
结局指标
主要结局
Increased Graft Function after Stem Cell Transplantation (SCT)
时间窗: 4 weeks
Blood drawn for signs of graft versus host disease (GVHD).
次要结局
未报告次要终点