A human tissue-engineered product (hTEP) means any autologous or allogeneic product which:
- contains, consists of, or results in engineered human cells or tissues; and
- has properties for, or is presented as having properties for, the regeneration, repair or replacement of tissue, where the new tissue or cells, in whole or in part, are structurally and functionally analogous to the original tissue that is being regenerated, repaired or replaced.
Engineered means any process whereby human cells or tissues have been substantially manipulated, so that their normal/specific physiological functions have been attained. Human tissue-engineered products are derived from living cells or tissues, with the final product containing viable or non-viable cells. They may, for their function, also contain cellular products, bio-molecules and biomaterials (including chemical substances, scaffolds and matrices).