Autologous/Allogeneic Progenitor Stem Cell Therapy for Congestive Heart Failure
Phase 1 Study: Autologous/Allogeneic Bone Marrow Progenitor Cell Treatment for Heart Failure
This research study is being performed to find out more information about the safety and effectiveness of injecting bone marrow progenitor cells (BMPCs) from one's own hip bone into one's heart muscle. The BMPCs are the cells from which the different types of blood and other cells grow.
In patients with heart failure, the heart muscle does not pump well. Over a period of years, this continues to get worse until the patient dies of heart failure. The investigators are trying to find out if the injection of these BMPCs can make a change in the functioning of these areas of the heart muscle. Data from studies around the world have suggested that when patients with heart failure receive these cells by direct injection into their hearts they show signs of recovered heart function, however, there has been no evidence from actual studies of the cells of the patient's hearts to show how this process works. It is the investigator's plan to inject an eligible participant's heart with cells that are from one's own bone marrow during an operation to receive a ventricular assist device (VAD) or partial artificial heart and then to study the function of the heart while awaiting a heart transplant. The investigators will then examine the heart after it has been removed as part of the regular heart transplant operation for any microscopic changes (changes too small to be seen by the unaided eye but large enough to be studied under a microscope) at the site where the cells are injected. Participants will have no change in the chances of receiving a heart transplant by agreeing to participate in this study. There will also be no delay in receiving a VAD operation while waiting to participate in this study. This Phase I study has been cleared by the Food and Drug Administration (FDA) to enroll and treat patients. The Center for Biologics Evaluation and Research Investigational New Drug number (IND BB #) is 12304. (A Phase I trial is a research study using techniques or products in the first-stage or for the first time in human subjects).
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 阶段1
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age >=18 years.
- Congestive heart failure with ejection fraction <= 35.
- Candidates for ventricular device placement as a bridge to transplant.
- Serum bilirubin, SGOT and SGPT <= 2.5 times the upper level of normal.
- Serum creatinine < 2.0 times normal or no dialysis.
- New York Heart Association (NYHA) performance status > 3.
- Negative pregnancy test (in women with childbearing potential).
Exclusion Criteria:
- Pregnant or breastfeeding women.
- History of prior radiation exposure.
- History of bone marrow disorder.
- History of abnormal bleeding or clotting.
- History of liver cirrhosis.
- Inability to obtain 1 x 10^6 CD 34+ cells after bone marrow processing.
- Acute myocardial infarction < 6 days from acute event.
- Prior malignancy in the 5 years before treatment in this study (other than curatively treated carcinoma in-situ of the cervix or non-melanoma skin cancer).
- Inability or unwillingness to comply with the treatment protocol, follow-up, research tests, or give consent.
- Eligible for destination ventricular assist device placement.
- Unable to have 250cc bone marrow harvested.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 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:open
open treatment
|
Biological implant into the heart
Biological implant into the heart
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Heart function at 3 months after implant
大体时间:3 months
|
3 months
|
次要结果测量
结果测量 |
大体时间 |
---|---|
毒性
大体时间:3个月
|
3个月
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
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)
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
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