NCT01086787Unknown不适用
Paracrine Mechanisms of Bone Marrow Stem Cell Signalling in Chronic Heart Failure
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Paracrine properties of bone marrow cells from patients with heart failure
研究概览
简要总结
The investigators hypothesize that chronic heart failure is associated with a general stem cell dysfunction, which translates into reduced paracrine function of adult stem cells from patients with chronic heart failure as compared to patients with preserved systolic function.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •For all participants:
- •Before any study-specific procedures, the appropriate written informed consent must be obtained.
- •Male and female older than 18 years of age.
- •For the cardiac patients:
- •Being accepted for cardiothoracic surgery with the use of open chest surgery
- •A known left ventricular ejection fraction, either assessed by echocardiography, MUGA or MRI. If LVEF <40% a subject will be assigned to the chronic heart failure group, if LVEF >40% a subject will be assigned to the control group.
- •For the non-cardiac patients:
- •Accepted for orthopedic surgery (e.g. total hip replacement) at the department of orthopedic surgery.
排除标准
- •An unstable medical condition, defined as having been hospitalized for a non-cardiac condition within 4 weeks of screening, or otherwise unstable in the judgment of the investigator (e.g. at risk of complications or adverse events unrelated to study participation).
- •Younger than 18 years of age.
- •Clinical history of chronic kidney disease (at any point prior to registration).
- •Any known hepatic disease.
- •Recent (within 3 months) history of alcohol or illicit drug abuse disorder, based on self-report.
- •Clinically significant abnormality in chemistry, hematology, or urinalysis parameters performed within the screening period.
- •Participation in any investigational device or drug trial(s) or receiving investigational agent(s) within 30 days.
- •Any condition (e.g. psychiatric illness, etc.) or situation that, in the investigator's opinion, could put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
- •Legally incompetent adults, for which reason what so ever.
- •For the non-cardiac patients:
- •A known history of cardiovascular disease.
结局指标
主要结局
Paracrine properties of bone marrow cells from patients with heart failure
时间窗: 1 day
To compare the paracrine properties of bone marrow-derived stem cells harvested from patients suffering chronic heart failure vs healthy subjects. In particular, we aim to determine if the cytoprotective, pro-angiogenic and anti-fibrotic effects mediated by bone marrow stem cells of heart failure patients are similar to those from healthy patients.
次要结局
- To study preconditioning of different bone marrow stem cells with different cytokines(1 day)
- To study in detail the temporal and spatial expression of paracrine factors in bone marrow stem cells in vitro, and to study the differences between bone marrow stem cells from patients with and without chronic heart failure(1 day)
- To evaluate potential molecular mechanisms involved(1 day)
- To find mechanisms to enhance expansion of different bone marrow stem cells in vitro(1 day)
研究者
研究点 (2)
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