Assessment of a Therapeutic Device for Treatment of Acute Lung Injury Using a Combat-Relevant Porcine Model
Abstract
Purpose: Acute lung injury (ALI) occurs in >30 percent of combat casualties. Inflammation is a key component and therapeutic strategies to block it are expected to decrease morbidity/mortality. Investigations directed at ways to limit activation and accumulation of leukocytes at sites of inflammation may prove clinically effective. Scope/Aims: Modulating neutrophil and monocyte/macrophage activity, the effector cells of the innate immune system, is a novel approach to diminish inflammation-induced disease processes without interfering with other immunologic activity, thereby avoiding adverse side effects. Innovative BioTherapies developed a selective cytopheretic device (SCD) therapy (Rx), to address this unmet medical need. SCDRx has been shown to improve clinical outcomes of critically ill patients with multi-organ failure by mitigating the inflammatory cascade. Specific Aim 1. Optimize a two-hit porcine ALI model relevant to combat situations. Specific Aim 2. Assess efficacy of 24h SCDRx in the porcine model. Progress to date. Yr 1: Animal approvals obtained. 17 studies conducted yielding study and analysis protocols (Aim 1 met). Yr2: Began assessment of SCDRx efficacy in porcine model. 17 studies conducted and significant therapeutic benefit was observed (Aim 2 initiated). Yr3: Continued assessment of SCDRx efficacy (18 studies planned). 5 studies were conducted using a larger device and even greater benefit was observed. A corporate restructuring resulted in loss of personnel and interrupted the work. A 1 year no cost extension has been requested to complete the project.
Document Details
- Document Type
- Technical Report
- Publication Date
- Dec 01, 2019
- Accession Number
- AD1088155
Entities
People
- Angela Westover
- H. D. Humes
- Jeffrey Curtis
- Kimberly A Johnston
Organizations
- Innovative BioTherapies (United States)