Chemotherapy: Open Access
Open Access

Yamato M

Publications

• Commentary
  Diverse Approval Systems for Autologous Human Cells and Tissue Products
  Author(s): Yano K, Watanabe N and Yamato MYano K, Watanabe N and Yamato M
  
  Human cells and tissue products are newly categorized products which are containing, consisting of, or derived from cells or tissue that are intended for implantation, transplantation, infusion, or transfer into human recipient. The human cells and tissue products are divided as autologous or allogeneic based on their origin. Since another product fabricated with patient?s own limbal epithelial stem cells, was approved as conditional approval for therapeutic indication which is the treatment of adult patients with moderate to severe limbal stem cell deficiency in the European Union, we reviewed the European Public Assessment Report. Of the ten autologous human cells and tissue products, the five products were evaluated using the clinical data with clinical experiences as well as retrospective observatory study or registry, or open clinical trials with small subjects, although for the res.. View More»
  DOI: 10.4172/2167-7700.1000157

  Abstract PDF

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