Apoptotic Cell (AC) Uptake by Human Alveolar Macrophages (AM)
2016年1月4日 更新者:VA Office of Research and Development
Apoptotic Cell Ingestion by Normal Human Alveolar Macrophages
The purpose of this study is to compare the ability of two types of white blood cells to eat dead host cells, and how this process affects their ability to protect the body from infection.
The two cell types are monocytes, a cell in the bloodstream, and alveolar macrophages, a cell in the lung that is ultimately derived from monocytes
研究概览
详细说明
Volunteers, who may be Veterans or non-Veterans, will be screened by a series of questionnaires, chest X-ray, spirometry, EKG, blood work, and a complete history and physician examination by a study physician.
Those who qualify for the study and agree via informed consent, will undergo a fiberoptic bronchoscopy on a separate day for the initial visit.
Bronchoscopy is a procedure in which a flexible video instrument is passed via the nose or mouth, through the vocal cords and into the lungs.
During the procedure, portions of the lungs will be washed ("lavaged") with a salt water solution, to collect the alveolar macrophages.
This procedure involves conscious sedation, so that a driver is required on the day of the bronchoscopy.
The entire procedure, including placement of an intravenous line to administer medications, local anesthetics, the bronchoscopy itself, and the recovery period, takes about 2.5-3 hours.
The cells collected by bronchoscopy will be studied in the research laboratory, and used entirely in that procedure.
研究类型
观察性的
注册 (实际的)
17
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Michigan
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Ann Arbor、Michigan、美国、48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
概率样本
研究人群
Volunteer subjects recruited from the community; may be current or ex-smokers or never-smokers, but must be healthy enough to undergo research bronchoscopy safely.
描述
Inclusion Criteria:
- Veteran or non-Veteran
- Able to give informed consent
Exclusion Criteria:
- Unstable heart disease
- Other systemic disease and unlikely to survive at least 2 years
- Mental incompetence
- Prednisone >20 mg/day
- Participation in another interventional protocol within last 6 weeks
- Asthma
- Cystic fibrosis
- Clinically significant bronchiectasis
- Lung cancer or any cancer not in remission for at least 5 years
- Other inflammatory or fibrotic lung disease
- Use of antibiotics for a lung infection within the past 4 weeks
- Autoimmune disease, i.e., Rheumatoid arthritis, systemic lupus erythematosus, autoimmune hepatitis, Crohn's disease or other
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
---|---|
Group 1
volunteer subjects
|
which a flexible video instrument is passed via the nose or mouth, through the vocal cords and into the lungs.
During the procedure, portions of the lungs will be washed ("lavaged") with a salt water solution, to collect the alveolar macrophages.
This procedure involves conscious sedation, so that a driver is required on the day of the bronchoscopy.
The entire procedure, including placement of an intravenous line to administer medications, local anesthetics, the bronchoscopy itself, and the recovery period, takes about 2.5-3 hours.
Blood will be collected at the enrollment visit to test the subject to exclude disorders that would make it unsafe to perform the bronchoscopy, including severe anemia, infection, or disorders of kidney or liver function.
An intravenous catheter is placed on the day of the bronchoscopy to permit administration of sedative medications.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
macrophage uptake of apoptotic cells in vitro
大体时间:1-7 days
|
1-7 days
|
次要结果测量
结果测量 |
大体时间 |
---|---|
spirometric measurement of lung function
大体时间:1-30 days
|
1-30 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Jeffrey L Curtis, MD、VA Ann Arbor Healthcare System, Ann Arbor, MI
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Bourdonnay E, Zaslona Z, Penke LR, Speth JM, Schneider DJ, Przybranowski S, Swanson JA, Mancuso P, Freeman CM, Curtis JL, Peters-Golden M. Transcellular delivery of vesicular SOCS proteins from macrophages to epithelial cells blunts inflammatory signaling. J Exp Med. 2015 May 4;212(5):729-42. doi: 10.1084/jem.20141675. Epub 2015 Apr 6.
- Todt JC, Freeman CM, Brown JP, Sonstein J, Ames TM, McCubbrey AL, Martinez FJ, Chensue SW, Beck JM, Curtis JL. Smoking decreases the response of human lung macrophages to double-stranded RNA by reducing TLR3 expression. Respir Res. 2013 Mar 9;14(1):33. doi: 10.1186/1465-9921-14-33.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年2月1日
初级完成 (实际的)
2015年6月1日
研究完成 (实际的)
2015年12月1日
研究注册日期
首次提交
2010年3月30日
首先提交符合 QC 标准的
2010年4月5日
首次发布 (估计)
2010年4月7日
研究记录更新
最后更新发布 (估计)
2016年1月6日
上次提交的符合 QC 标准的更新
2016年1月4日
最后验证
2016年1月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- Curtis 0015
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.