用于 CD34+ 细胞选择的 Miltenyi 设备的同情访问
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).
研究概览
详细说明
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.
Before the infusion, you will receive Tylenol (acetaminophen) by mouth and Benadryl (diphenhydramine hydrochloride) by mouth or vein about 30-60 minutes before the infusion. These drugs will be used to help lower the risk of side effects. If side effects occur during the infusion, the doses of the drugs may be adjusted (up or down) until the symptoms are gone. Also, if you have side effects during the infusion, you will be observed for 2 hours after it is given or until the symptoms have stopped completely (whichever is later). During this time, your blood pressure, heart rate, breathing rate, temperature, and the level of oxygen in your blood will be checked every 15-30 minutes.
About 4-6 weeks after the first infusion, you may receive an additional infusion, if your doctor thinks it is needed.
Clinic Visits:
One (1) time a week after the infusion, until your doctor thinks it is no longer clinically needed, you will have the following tests:
- Blood (about 1 teaspoon) will be drawn for routine tests.
- You will be checked for signs of graft versus host disease (GVHD). Symptoms of GVHD include skin rash, nausea, vomiting, diarrhea, and abnormal liver function.
This is an investigational study. The CD34 positive stem cell infusion to help boost cell counts is not FDA approved.
Up to 75 patients will be enrolled on this treatment.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Elizabeth Shpall, MD
- 电话号码：713-745-2161
- 邮箱：eshpall@mdanderson.org
学习地点
-
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Texas
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Houston、Texas、美国、77030
- 招聘中
- University of Texas MD Anderson Cancer Center
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
1) Patients who have poor or no graft function post stem cell transplantation.
Exclusion Criteria:
N/A
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
Participants infused by vein with around 1 - 4 million/kg CD34+ selected cells. Miltenyi device is used for CD34+ cell infusions) to patients who experience poor graft function after stem cell transplantation (SCT).
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Increased Graft Function after Stem Cell Transplantation (SCT)
大体时间：4 weeks
|
Blood drawn for signs of graft versus host disease (GVHD). |
4 weeks
|
合作者和调查者
调查人员
- 首席研究员：Elizabeth Shpall, MD、M.D. Anderson Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.