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Targeted LystaMab Therapy to Optimize Tissue Engineered Vascular Graft Performance

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HL144143-01
Agency Tracking Number: R41HL144143
Amount: $222,703.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NHLBI
Solicitation Number: PA17-303
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-08-15
Award End Date (Contract End Date): 2019-07-31
Small Business Information
Columbus, OH 43212-1180
United States
DUNS: 079811792
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (614) 355-5754
Business Contact
Phone: (216) 374-4502
Research Institution
COLUMBUS, OH 43205-2664
United States

 Domestic Nonprofit Research Organization

Project Description
Despite significant advances in the surgical and medical management of congenital heart diseasecongenital
cardiac anomalies remain a leading cause of death in the newborn periodMost severe forms of congenital
heart disease require surgical interventionComplications arising from the use of currently available prosthetic
materials in the form of vascular graftspatchesor replacement heart valves are a leading source of morbidity
and mortality after congenital heart surgeryCurrently available prosthetic materials such as
polytetrafluoroethylene are a significant source of thromboembolismhave poor durability due to neointimal
hyperplasiaare susceptible to infectionand perhaps most importantly lack growth capacitywhich results in
the need for additional operations as children outgrow their prostheticsThe development of better biomaterials
with growth potential could substantially improve the outcomes of children requiring congenital heart surgery by
reducing the number of graft related complications and enabling earlier definitive surgical repair without risk of
serial re operationsTissue engineering offers a potential solution to this vexing problemUsing tissue
engineering methodsbioprosthetics can be made from an individual s own cells creating a living material with
excellent biocompatibility and the ability to growrepairand remodelThe goal of this application is to optimize
the design of an improved vascular graft for use in congenital heart surgeryUsing the tissue engineered
vascular graftTEVGas a model for bioprosthetics specifically developed for use in congenital heart surgerywe will rationally design an improved TEVG based on the mechanisms underlying vascular neotissue formationWe will focus our work on developing strategies for inhibiting TEVG stenosis by anti LYST immunomodulationThe successful development of therapeutic strategies for inhibiting TEVG stenosis would overcome a critical
barrier preventing the widespread use of this promising technology Public Health Relevance Statement
Congenital cardiac anomalies are the most common birth defect and a leading cause of death in the newborn
periodThe most effective treatment for congenital cardiac anomalies is reconstructive surgeryUnfortunatelycomplications arising from the use of currently available vascular conduits are a significant cause of
postoperative morbidity and mortalityThe development and translation of an improved vascular graftcreated
from an individual s own cellswith the ability to grow and remodelholds great promise for advancing the field
of congenital heart surgery and improving outcomes of infants requiring surgical intervention

* Information listed above is at the time of submission. *

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