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Validation of a Human In Vitro Vaginal Irritation Test

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
85744
Program Year/Program:
2009 / SBIR
Agency Tracking Number:
HD050023
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
MATTEK CORPORATION
200 HOMER AVE ASHLAND, MA -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2009
Title: Validation of a Human In Vitro Vaginal Irritation Test
Agency: HHS
Contract: 2R44HD050023-02
Award Amount: $1,205,751.00
 

Abstract:

DESCRIPTION (provided by applicant): During Phase 1 research, the effects of 6 model test materials on a highly differentiated vaginal- ectocervical (VEC) tissue model were studied. Effects on tissue viability, structure, barrier function, and inflammatory cytokine release were monitored. Many of the assays gave results which supported one another and increased confidence in the in vitro results. For instance, histological damage and cytokine release paralleled losses in tissue viability. In addition, decre ases in barrier function were measured when tissue viability decreased although the data indicated that barrier function was a more sensitive endpoint (i.e. decreases in barrier function occurred at lower concentrations that did not decrease tissue viabili ty). Importantly, the one material which was mildly irritating in the rabbit vaginal irritation test induced significant decreases in tissue viability and barrier function and increased inflammatory mediator release. In addition, an economic analysis showe d the in vitro method to be a cost-effective alternative to the currently used rabbit vaginal irritation test methodology. During Phase 2, the utility of the in vitro assay system will be further expanded to predict vaginal irritation following chronic, re peat exposure. Using the endpoints developed in Phase 1, a prediction model will be developed to accurately assess the in vivo vaginal irritation of test materials and formulations. The method will be transferred to outside contract testing labs and a mult i-lab GLP validation study will be performed. In addition, the short and long term reproducibility of the assay will be assessed, and a high throughput version of the assay method will be developed. PUBLIC HEALTH RELEVANCE: A predictive test system for ass essing the vaginal irritation potential of chemicals and formulations will have far reaching application in industries involved in women's care products, microbicide, contraceptives, excipient development, and topical pharmaceutical products. Evaluation of vaginal irritation is important to minimize chemical hazards to millions of women. The proposed human reconstructed tissue based system will provide a sensitive and validated assay method for screening of chemicals/formulations with vaginal irritation pot ential. Furthermore, the assay method will be cost effective and reduce the use of laboratory animals for experimentation.

Principal Investigator:

Seyoum Ayehunie
5088816771
SAYEHUNIE@MATTEK.COM

Business Contact:

Seyoum Ayehunie
mklausner@mattek.com
Small Business Information at Submission:

MATTEK CORPORATION
MATTEK CORPORATION 200 HOMER AVE ASHLAND, MA -

EIN/Tax ID: 042877744
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No