Assessment of a Therapeutic Device for Treatment of Acute Lung Injury Using a Combat-Relevant Porcine Model
Technical Report,01 Sep 2016,31 Aug 2019
Innovative BioTherapies, Inc. Ann Arbor United States
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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 morbiditymortality. Investigations directed at ways to limit activation and accumulation of leukocytes at sites of inflammation may prove clinically effective. ScopeAims Modulating neutrophil and monocytemacrophage 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.