Hospital Of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
NCT Number: NCT07125079
Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) is a condition where high levels of inflammation damage the lung. This is a highly morbid condition with no specific pharmacologic therapies. The investigators posit that ARDS is caused due to an exaggerated activation of immune cells and that blockade of this activation may reduce lung damage/injury and help in ARDS management and possibly recovery. To test this hypothesis, the investigators propose to generate an in vitro immune cell model and test a novel (reactive oxygen species) blocking agent PIP-2 on this model. The investigating team will obtain blood of ARDS patients and isolate immune cells (specifically peripheral blood mononuclear cells or PBMC) and monitor the activation of these cells and their blockade by PIP-2. This is entirely an in vitro study.
Interested in participating?
Request Info21 year–90 year
All sexes
Observational
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
The research study is being conducted to understand the behavior of immune cells in a patient with Acute Respiratory Distress Syndrome (ARDS). Immune cells protect humans from external threats like infection. However, if these cells are overactive, they can lead to an infection progressing into ARDS. ARDS arises as a result of extensive damage possibly due to overactivated immune cells. This project aims to understand the link between immune cell activation and ARDS.
To do so, the investigators will isolate immune cells specifically peripheral blood mononuclear cells (PBMC) from blood of ARDS patients. These cells will be utilized for in vitro experiments by checking for overactivation. Cells in vitro will also be treated with a novel synthetic agent PIP-2 (being developed Peroxitech Inc. a Collaborator of this study) to check if PIP-2 can reduce overactivation as monitored by the production of reactive oxygen species.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
ARDS patients with mild and moderate to severe ARDS. This will be based on PaO2/FiO2 in the range of 100 mmHg (severe) and moderate (100-200 mm Hg) and mild (200-300 mm Hg) -
Exclusion criteria
Pregnant women, children will be excluded.
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Time frame: From enrollment until 21 days
Peripheral Blood Mononuclear cells (PBMC) isolated
Contact information is provided by the study sponsor or research team.
Christian Bermudez, MD
CONTACT
Shampa Chatterjee, PhD
CONTACT
University of Pennsylvania
Other
Blood-based Biomarkers of Acute Lung Injury/Acute Respiratory Distress Syndrome
Acronym: ALI/ARDS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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