Assessment of a Therapeutic Device for Treatment of Acute Lung Injury Using a Combat-Relevant Porcine Model
Abstract
Problem: This proposal addresses the Fiscal Year 2015 Peer Reviewed Medical Research Program Topic Area of "Acute Lung Injury." A gap in clinical treatment for acute lung injury has been identified. This disease has been of great interest to the medical community since its clinical recognition in the late 1960s by both civilian physicians and military surgeons treating casualties of the Vietnam War. Acute lung injury affects more than 190,000 Americans every year and occurs in greater than 30% of combat casualties. Mortality rates from acute lung injury are as high as 58%. Despite clinical advances in supportive care, there are no therapeutic interventions that treat the body s response that occurs during acute lung injury. Solution: The focus of this proposal is to determine if a device that was developed by Innovative BioTherapies can prevent or treat acute lung injury. This device, called the SCD, works by taking a type of blood cell that becomes very active when someone gets sick and making it less active. These special blood cells are called leukocytes. There is more than one type of leukocyte. The types that the SCD act on are called neutrophils and monocytes. The SCD is hooked up to a person, similar to kidney dialysis, by a tubing and blood pump system. This system pumps blood (less than 5% of the total amount of blood in one s body) out of the patient s body, into the tubing system and through the SCD; the blood then is returned to the body. The SCD has special fibers that allow the neutrophils and monocytes to attach to them, where an agent is infused into the SCD and causes the blood cells to be less active, so when the blood cells are released from the fibers they are no longer harmful to the sick patient. The SCD has been used to treat patients in a clinical trial that was approved by the Food and Drug Administration (FDA). The patients in the clinical trial had acute kidney injury and two other organs (such as lung and heart) that were injured. In the most recent clinical trial, there were only 16% of the SCD-treated patients who either did not survive 60 days or needed to be on kidney dialysis at 60 days after therapy, compared to 58% of the untreated patients. This difference of 16% compared to 58% shows how much of a positive impact the SCD had in these very sick patients. Project Plan: These excellent clinical results support the evaluation of this technology in other patient populations that have acute organ injury. The study plan has two main goals: (1) Develop a pig model of acute lung injury that causes a similar degree of injury as that seen under combat conditions. (2) Use this pig model to determine if the SCD positively affects the acute lung injury condition. Short-Term Outcome: The combat-relevant acute lung injury pig model will be able to be used by doctors and scientists for testing a variety of drugs or devices for the treatment of acute lung injury. The studies with the SCD will help detail how the SCD works to make leukocytes be less harmful during the disease state of acute lung injury. Long-Term Outcome: The successful completion of this preclinical evaluation of the SCD in this military-relevant porcine model of acute lung injury will result in a submission to the FDA to evaluate the safety and efficacy of this device in patients with acute lung injury arising in combat casualty, older Veterans at Department of Veterans Affairs (VA) facilities, and the general population in non-military/VA medical facilities. The transfer of the work from this proposal to the clinic will be a critical step to developing a targeted therapeutic immunomodulatory approach (one that allows/helps the body s natural defense to fight a disease) to treat and improve clinical outcomes of patients suffering from acute lung injury, a disease currently lacking any specific therapeutic intervention.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 31, 2017
- Source ID
- W81XWH1610463
Entities
People
- H. Humes
Organizations
- Innovative BioTherapies (United States)
- United States Army