The Effect of Intramyocardial Injection of Immunoselected Bone Marrow Cells on Myocardial Function in LVAD Bridge to Transplant Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 14
- 主要终点
- Duration of Time (Minutes) a Patient is Able to Tolerate Wean
研究概览
简要总结
Heart failure is a condition in which the heart is unable to pump enough blood to the body's other organs. A heart transplant may be necessary for some individuals with end-stage heart failure. Left ventricular assist devices (LVADs) can assist the heart in pumping blood, and are commonly used until a donor heart becomes available. Bone marrow cells injected into the heart may improve heart function and may lead to earlier LVAD removal. The purpose of this study is to evaluate the safety and effectiveness of injected bone marrow cells in improving heart function in individuals with LVADs who are awaiting heart transplants.
详细描述
Congestive heart failure affects 5 million people in the United States, and over 60,000 are diagnosed with end-stage heart failure. Treatment options for these individuals are extremely limited. Because of a limited supply of donor organs, fewer than 3,000 people receive heart transplants each year. LVADs are battery-operated devices that can act as a temporary solution until a donor heart becomes available. Upon being surgically implanted into a weakened heart, the LVAD mechanically pumps blood from the heart to the rest of the body. There are, however, serious risks associated with LVADs, including infection, blood clots, and stroke. Early removal of the LVAD may be possible by injecting stem cells to regenerate new heart cells and improve heart function. The purpose of this study is to compare the safety and effectiveness of two types of bone marrow cells -- bone marrow mononuclear cells (BMCs) and immunoselected CD34+ hematopoietic stem cells -- in improving heart function in individuals with end-stage heart failure.
This study will enroll individuals undergoing surgery to receive an LVAD. Participants will be randomly assigned to one of following three groups:
Group 1 (n=30): participants will undergo intramyocardial injection of bone marrow mononuclear cells (BMCs) during LVAD implantation
Group 2 (n=30): participants will undergo intramyocardial injection of immunoselected CD34+ hematopoietic stem cells during LVAD implantation
Group 3 (n=15): participants will undergo LVAD implantation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1
Intramyocardial injection of bone marrow mononuclear cells + LVAD
干预措施: Intramyocardial injection of bone marrow mononuclear cells (Biological)
Group 2
Intramyocardial injection of CD34+ selected bone marrow mononuclear cells + LVAD
干预措施: Intramyocardial injection of CD34+ selected bone marrow mononuclear cells (Biological)
Group 3
LVAD alone
干预措施: LVAD alone (Device)
结局指标
主要结局
Duration of Time (Minutes) a Patient is Able to Tolerate Wean
时间窗: Measured 90 days post-intervention
This defines the functional status. Due to poor enrollment, data was not analyzed.
次要结局
- Prevalence of Normal Echocardiographic Assessments(Measured at baseline, Days 45 and 90 post-intervention, every 60 days thereafter until transplant)
- Number of Patients Who Completed a Six Minute Walk(Measured at Days 45 and 90 post-intervention, every 60 days thereafter until transplant)
研究者
Yoshifumi Naka
Professor of Surgery, Department of Surgery CT
Columbia University