NCT02026934No Longer Available不适用
CliniMACS® CD34+ Reagent System for Expanded Access Use
Joseph Antin1 个研究点 分布在 1 个国家开始时间: 2013年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- 试验地点
- 1
研究概览
简要总结
CliniMACs is an investigational device used to select and enrich stem cells. The device will select the stem cells with CD34+ protein. The participant will be infused with the CD34+ selected cells in the hopes that it will help the participant engraft. Engraftment is when transplanted stem cells resume production of healthy blood cells.
详细描述
- After the screening procedures confirm that the participant is eligible to participate in the research study: If the participant takes part in this research study, the participant (and their donor) will have the following tests and procedures:
- Donor Graft Collection: The participant's cell donor will undergo stem cell collection. The cells collected will be sent to the laboratory for processing.
- Donor Graft Processing: In the laboratory the CliniMACS device will be used to separate the CD34+ stem cells from the other types of cells in the graft. After completing the necessary safety tests, the CD34+ selected donor graft will be ready for administration.
- Donor Graft Infusion: The CD34+ selected donor graft will be infused through an intravenous (I.V.) catheter. The day of this infusion is called Day 0.
- Follow-Up Visits: Approximately 3, 6 and 12 months after the donor graft infusion, the participant will return to clinic for follow-up visits. At each of the visits, the participant will have a physical exam and asked questions about your general health. The participant will also have routine blood tests performed (approximately 1 tablespoon of blood).
- At times more cells are collected from a donation than are needed to do the transplantation. If your physician determines that it is preferable to administer a dose of cells that is less than the complete collection, the extra cells may be frozen and stored in our freezers for the participant's future use. If the cell counts do not improve, the participant will be given the remaining cells through an intravenous (I.V.) catheter.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged >18 years
- •Diagnosis is graft exhaustion.
- •Ability to understand and willingness to sign a written informed consent document
- •Matched related or unrelated donor must consent to provide an allograft.
排除标准
- •Symptomatic or uncontrolled cardiac failure or coronary artery disease.
- •Karnofsky performance status < 60%.
研究者
Joseph Antin
Sponsor/Co-Investigator
Dana-Farber Cancer Institute
研究点 (1)
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