Using patient blood cells to test whether PIP-2 calms immune activation in ARDS
Blood-based Biomarkers of Acute Lung Injury/Acute Respiratory Distress Syndrome
This project will test whether a drug called PIP-2 can calm overactive immune cells taken from people with ARDS.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 36 (estimated) |
| Ages | 21 Years to 90 Years |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07125079 on ClinicalTrials.gov |
What this trial studies
Researchers will collect blood from adults with mild to severe ARDS and isolate peripheral blood mononuclear cells (PBMCs). In the laboratory, they will measure immune cell activation and reactive oxygen species production in these patient-derived cells. The isolated cells will be treated in vitro with the experimental agent PIP-2 to see whether it reduces markers of activation and oxidative stress. No investigational drug will be given to patients; all testing is performed on cells in the lab.
Who should consider this trial
Good fit: Adult patients with ARDS (PaO2/FiO2 approximately 100–300 mmHg, covering mild to severe cases) who can provide blood samples and are not pregnant are the intended participants.
Not a fit: Pregnant people, children, individuals without ARDS, or those unable to give blood are not eligible and would not receive any direct benefit from this in vitro work.
Why it matters
Potential benefit: If PIP-2 lowers harmful immune activation in patient cells, it could point to a new treatment approach that reduces immune-driven lung injury in ARDS.
How similar studies have performed: Targeting reactive oxygen species and immune overactivation has shown benefit in animal and laboratory models, but PIP-2 itself is a novel agent not yet tested in patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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. \-
Where this trial is running
Philadelphia, Pennsylvania
- Hospital Of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Shampa Chatterjee, PhD — University of Pennsylvania
- Study coordinator: Shampa Chatterjee, PhD
- Email: shampac@pennmedicine.upenn.edu
- Phone: 215-898-9101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.