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Human Corneal Model for Ocular Irritation Assay

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
Program Year/Program:
2011 / SBIR
Agency Tracking Number:
R44ES020074
Solicitation Year:
2011
Solicitation Topic Code:
NIEHS
Solicitation Number:
PA09-080
Small Business Information
MATTEK CORPORATION
200 HOMER AVE ASHLAND, MA -
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Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2011
Title: Human Corneal Model for Ocular Irritation Assay
Agency: HHS
Contract: 9R44ES020074-02
Award Amount: $924,517.00
 

Abstract:

DESCRIPTION (provided by applicant): Replacement of the Draize rabbit eye test for ocular irritancy testing remains an elusive goal. Many believe a corneal full thickness (CFT) model is necessary to completely model the interaction of exogenous chemicals with human cornea. During Phase 1, human corneal epithelial, stromal, and endothelial cells were isolated from native tissue, expanded in monolayer culture, and cryopreserved. Culture conditions were identified to produce highly differentiated 2-layer (corneal epithelium and keratocyte-containing stroma) and 3- layer (epithelium, stroma, and endothelium) CFT tissues. The CFT tissues exhibited improvements over epithelial tissues in terms of barrier and differentiated phenotype. An assay and prediction model(PM) was developed which allowed the CFT tissue to distinguish between irritants and non-irritants with 100% accuracy. Other functional studies showed that the CFT tissue appears suitable to evaluate time to recovery (TTR) and depth of injury (DOI) following chemical injury. Finally, an analysis of CFT tissue production showed that the economics of CFT are favorable. Phase II will expand upon the Phase 1 result to further develop the CFT tissue model. Initial goals will focus on preparing the CFT tissue model for commercial production - cell stocks will be expanded to insure a stable cell supply and quality control parameters will be developed. The database of materials tested using the CFT will be expanded, the PM for irritant/non-irritant classification will be finalized, and inter-laboratory transferability of the assay will be demonstrated. Finally, the CFT tissues will be used for TTR and DOI measurements and an assay and prediction model for replacement of the Draize test will be developed. Due to theseenhanced capabilities, the CFT will provide toxicologists and scientists with a tool that will dramatically decrease, if not entirely eliminate, the need for animal testing to determine ocular irritancy. PUBLIC HEALTH RELEVANCE: Safety assessment of all new chemicals and products requires evaluation of potential ocular irritancy in case of intentional or unintentional exposure to the eye. Current animal-based test methods are suboptimal because of animal welfare concerns and in vitro methods lack the complexity required to completely model in vivo responses. We will develop a corneal full thickness tissue and in vitro test methods that will dramatically reduce or eliminate the need to use animals to assess ocular irritancy of chemicals and products.

Principal Investigator:

Yulia Kaluzhny
508-881-6771
ykaluzhny@mattek.com

Business Contact:

Mitchell Klausner
508-881-6771
mklausner@mattek.com
Small Business Information at Submission:

MATTEK CORPORATION
200 HOMER AVE ASHLAND, MA -

EIN/Tax ID: 104287774
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No