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 The use of MucilAir^TM in carcinogenicity studies in vitro

The aim of the study

The aim of this research project is to develop and prevalidate a long-term carcinogenicity test based on MucilAir™, to replace the 2-year-bioassay on animals. MucilAir™ is an in vitro test-system of primary human respiratory epithelium, developed by Epithelix Sàrl, mimicking the in vivo tissue of the human respiratory epithelium.

Background

The existing scheme for carcinogenicity testing, comprising in vivo and in vitro genotoxicity testing as a first step and the 2-year-bioassay as the second step, demands toxicological tests with a substantial number of animals by law. At least for the 2-year-bioassay 800 animals are consumed and 4 to 6 years duration has to be calculated for one substance-testing only. Disadvantages are of economical, societal and scientific nature. Costs amount to 1,5 Mio. Euro per substance, using an assay that due to the scarification of animal is not well tolerated by the society and controversially discussed because of well known and described differences between the species used and man.
Until today the only non-animal alternative to study carcinogenic effects is the transformation assay. Its development lasted over two decades and culminated in a first validation step by the ECVAM with so far seven (7) compounds. The major disadvantage of this system is the lack of morphological resemblance to any human tissue and the use of permanent, genetically stable cell lines.
MucilAir™ is the first pure in vitro test model that overcomes the major obstacles in testing toxicity in vitro. It comprises human primary cells instead of cell lines, it resembles the native tissue with all its physiological characteristics and it has a shelf life of about one year, a unique characteristic in the field of in vitro tissue reconstitution. Therefore, this system is the first one that enables substance testing specific for all phases of carcinogenesis described so far in the animal experiment, starting with initial events causing DNA lesions, promoting substance effects and progressive outcome at the end of this process and thereby saving test animals, time and costs. It can be conducted during a manageable period of few weeks, which can keep the financial costs comparatively low and it finally meets the criteria of the 3R-concept in carcinogenicity testing.
Taking into account the very high costs of cancer treatment as well as the increasing number of humans suffering on cancers, an additional step for the future might be the evaluation of our test system for its potential as measures for prevention.

Project partners

Epithelix Sarl, Gent (CH), British American Tobacco (BAT), Southampton (GB), zet-LSL

Grants

British American Tobacco (BAT), Southampton (GB)