Regulatory barriers to tissue-engineered products.
Autologous tissue-engineering technology uses the body's own regenerative capacity to solve clinical problems. Human cellular- and tissue-based products include an array of medical products for repair, reproduction, replacement and other therapeutic purposes. However, the lack of European Union regulation for these products is putting the future of the technology at risk in Europe.
Schutte
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IsoTis NV, Bilthoven, The Netherlands. eliane.schutte@isotis.com
D003365:Costs and Cost Analysis; D005062:European Union; D006801:Humans; D007391:International Cooperation; D010330:Patents as Topic; D014015:Tissue Banks / Q000331:legislation & jurisprudence*; D023822:Tissue Engineering / Q000191:economics / Q000331:legislation & jurisprudence*; D014182:Transplantation, Autologous; D014481:United States