HUMAN TISSUE MODEL FOR VAGINAL IRRITATION STUDIES.

Recently, EpiVaginal™, a tissue culture-based model of the vaginal epithelium, has been developed. Normal, human ectocervico-vaginal (ECV) epithelial cells were induced to form a three-dimensional tissue using specially formulated serum free medium. The in vitro tissue reproduces many of the histological, ultrastructural, and protein expression properties of native tissue, including a multilayered three-dimensional morphology, inter-digitation of cells, glycogen production, and cytokeratin expression. Initial experiments by scientists at Johnson & Johnson (Personal Products Company) and MatTek Corp. investigated the use of this tissue model and the MTT tissue viability assay for predicting ECV irritation. Vaginal anti-fungal products, contraceptives and lubricants were exposed to the tissue model and the exposure time which causes a 50% reduction in tissue viability (ET-50) was determined. The ET-50s were compared to rabbit vaginal irritation scores for 7 products which are currently marketed or in clinical trials. Using an ET-50 cutoff of 9.0 hrs, the products could be successfully categorized into minimal or mild irritation classes. Based on these results and the problems associated with obtaining and the handling of human vaginal tissue, it is anticipated that the EpiVaginal tissue model will be very useful in assisting product development scientists in developing safe, efficacious products.

Anti-fungal, Anti-inflammatory, Contraceptives, ECV tissue, Ectocervical, Ectocervico, Ectocervix, EpiVaginal, Glycogen production, Irritation (skin), Lubricant, MTT, MTT ET-50 tissue viability assay, MTT assay, Moisturizer, Rabbit vaginal irritation, Vaginal epithelium, Vaginal irritation