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Regulatory challenges for autologous tissue engineered products

In Europe TEPs, somatic cell therapy medicinal products, and gene therapy medicinal products are summarised under the term advanced therapy medicinal products (ATMP) [1,2]. TEPs contain viable autolo- gous, allogenic or xenogenic cells. While somatic cell therapy medicinal products are intended to treat or prevent a disease or to make a diagno- sis through pharmacological, metabolic, and/or immunological action, the claim of TEP is to regenerate, repair, or replace human tissue [1,2]. TEPs are based on living cells and may additionally contain natural or synthetic extracellular components. Due to availability and regenerative capability of cells, tissue engineering (TE) presents new opportunities for physicians to help patients in various indications.

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