Carcinogenicity
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Carcinogenicity
Contract number
BRE2-CT94-0607 Proposal number
BE-8000
Start date
01-May-94 Duration
3 years
RTD programme
Brite-EuRam
Budget ECU
0
Coordinator
Dr R Eloy

Organisation
Biomatech SA

Street
Zone Industrielle de l'Islon
Street
Rue Pasteur
City
Chasse sur Rhône
Country
France Postcode
F-38670
Telephone
33 4 78079234 Fax
33 4 72240812
Email
n/a
Web_address
n/a
Partner
n/a
Partner
n/a
Partner
n/a
Summary
The project is concerned with understanding the factors involved in

carcinogenicity and the potential of biomaterials to initiate tumour

formation. It also is aimed at developing and validating a reliable test

procedure that assesses carcinogenic risk. The general objectives are

focused on the development and validation of:

1. an early molecular or cellular criteria of tumo-rigenesis

2. an in vitro assay for early screening of risk

3. an adequate in vivo protocol to confirm in vitro results using

developed tools

4. a proposal for revision of the relevant European and/or

International Standards and/or guidelines for assessment of

carcinogenic risk.
Achievements
A range of biomaterials, already in clinical use, have been selected as

“reference” materials, and chemically characterised and implanted in

animal models. The provision of molecular markers which can detect

changes in cells (around the sites of implantation) at the molecular and

gene expression level has been examined. Retrospective analyses of

explant tissues have been made in order to investigate “real” cellular

reactions and, potentially, allow correlations to be drawn. The products

of in vitro corrosion around metals, with associated levels of cytoxicity,

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