DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

Clinical Development of a Novel Pleural and Tracheal Sealant

Principal Investigator: WEISS, DANIEL
Institution Receiving Award: VERMONT & STATE AGRICULTURAL COLLEGE, UNIVERSITY OF
Program: PRMRP
Proposal Number: PR181641
Award Number: W81XWH-19-1-0313
Funding Mechanism: Expansion Award - Funding Level 2
Partnering Awards:
Award Amount: $1,721,432.47


PUBLIC ABSTRACT

A variety of lung diseases such as emphysema, infections, and lung cancers as well as lung injury from trauma, including battlefield trauma, can result in lung collapse that can be immediately life-threatening or result in chronic leaking of air or fluid out of the lung. These remain challenging medical problems for which few good options are currently available and result in significant morbidity, mortality, hospital stays, healthcare costs, and other complications. New options are thus desperately needed.

In parallel, tracheal injuries are less common but can be immediately life-threatening. These defects, which result from trauma, including battlefield, or disease, can be difficult to manage and require invasive surgery to repair the defect. In addition, congenital pediatric tracheal defects are difficult to treat with limited options for promoting normal growth and development as the patient ages.

We have developed a novel, easy-to-apply sealant patch that can repair lung and tracheal leaks and potentially also be used in congenital tracheal defects. This compound involves use of a modified form of alginate, a naturally occurring seaweed derivative, increasingly being explored for a variety of biomedical applications, conjugated with dopamine, the major component of adhesive proteins that allow mussels to attach to rocks. Particular attributes include easy availability, low manufacturing cost, easy use, and lack of toxicity. This is a simple and powerful new potential approach for treating lung and tracheal injuries.

The proposed studies will define optimal manufacturing and storage conditions for the sealant patch and will define long-term efficacy and safety in animal models of pleural and tracheal injuries. We will also explore efficacy and safety in animal models of pediatric tracheal injuries to assess potential use in congenital tracheal defects. Finally, we will assess initial efficacy in human lungs obtained from autopsy as a further step towards entering into discussions with the U.S. Food and Drug Administration (FDA) for design of initial clinical trials. The sealant patch also has commercialization potential that will be further explored for both military and civilian use.