It was only in December 2008 that the European Union regulated the approval procedure for tissue engineered products (TEPs). Due to this regulation, TEP is classified as an advanced therapy medicinal product and as such may be recognized as a tool in pharmaceutical biotechnology. This paper gives a short review of the concept, the experimental evaluation and the clinical potency of tissue engineering (TE), with a particular focus on bone tissue engineered products. After a period of great enthusiasm about TE at the end of the 20th century a slight disappointment followed in the early 2000s. The review refers also to the continuously growing scientific interest, accompanied by the still modest representation of TEPs on the medical market. Some remarks are given on a bench-to-clinic road, including criticism concerning data originating from animal experiments. An attempt is made to foresee the still promising future of bone tissue engineered products (BTEPs) in practical use.
Keywords: Bone, Tissue engineering, Medicinal product, Stem cells, Scaffold, intrinsic bioactivity, cytokines, allogenic transplantation, human periosteal cells, autologous marrow stromal cells, sheep metatarsals, pre-cultured cells, cell-based therapy, bone morphogenic proteins (BMP), calcium phosphate ceramics, human embryonic stem cells (hESCs)
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