Apoptotic Cell (AC) Uptake by Human Alveolar Macrophages (AM)
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Purpose
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
| Condition | Intervention |
|---|---|
|
Chronic Obstructive Pulmonary Disease |
Procedure: Fiberoptic bronchoscopy Procedure: blood draw Procedure: intravenous catheter |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Apoptotic Cell Ingestion by Normal Human Alveolar Macrophages |
- macrophage uptake of apoptotic cells in vitro [ Time Frame: 1-7 days ] [ Designated as safety issue: No ]
- spirometric measurement of lung function [ Time Frame: 1-30 days ] [ Designated as safety issue: No ]
Biospecimen Retention: None Retained
whole blood, white blood cells, serum, bronchoalveolar lavage fluid
| Estimated Enrollment: | 33 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Group 1
volunteer subjects
|
Procedure: Fiberoptic bronchoscopy
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.
Procedure: blood draw
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.
Procedure: intravenous catheter
An intravenous catheter is placed on the day of the bronchoscopy to permit administration of sedative medications.
Other Name: IV
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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.
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
Contacts and Locations| Contact: Lisa M McCloskey, RRT | (734) 769-7100 | lmcclosk@med.umich.edu |
| Contact: Jeffery L Curtis, MD | (734) 845-3457 | jlcurtis@umich.edu |
| United States, Michigan | |
| VA Ann Arbor Healthcare System | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Lisa M McCloskey, RRT 734-769-7100 lmcclosk@med.umich.edu | |
| Principal Investigator: Jeffery L. Curtis, MD | |
| Principal Investigator: | Jeffery L. Curtis, MD | VA Ann Arbor Healthcare System |
More Information
Additional Information:
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01099410 History of Changes |
| Other Study ID Numbers: | Curtis 0015 |
| Study First Received: | March 30, 2010 |
| Last Updated: | April 5, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
macrophages, alveolar monocytes Receptor Protein-Tyrosine Kinases Humans |
Phagocytosis Lung in vitro |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013