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EUTCD-Grade lines: an innovative approach to creating and supplying clinical hESC lines

Posted: 14 September 2017 | | No comments yet

The ever-increasing pressure to turn bench-top discoveries into new therapies has led to the re-purposing of embryonic stem cell lines, originally intended for basic research, for clinical applications…

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However, within the European Union any donated human tissue intended for use in patient treatment must comply with European Tissues and Cells Directive (EUTCD) requirements to ensure quality and patient safety. Initiatives are being undertaken to ensure that human pluripotent stem cell lines intended for use in future clinical therapies also follow these directives.

In February 2017, the UK Stem Cell Bank (UKSCB) released the first of a panel of 37 EUTCD-Grade human embryonic stem cell (hESC) lines for use in developing novel advanced therapies to be brought to clinical trial. Derived and banked under a licence from the UK regulator, the Human Tissues Authority (HTA), it is hoped these lines will set a benchmark in standards for clinical stem cell lines. Here we explore what EUTCD-Grade means, and outline the processes behind producing and accessing the UKSCB’s panel of hESC lines suitable for the development of cellular therapies.

The UKSCB is a world-leading, not-for-profit, stem cell bank distributing pluripotent stem cell lines qualified for use in clinical trials. Funded by the Medical Research Council (MRC) and the Biotechnology and Biological Sciences Research Council (BBSRC), the bank was established in 2003 at the National Institute for Biological Standards and Control (NIBSC), a centre of the Medicines and Healthcare products Regulatory Agency (MHRA).

What are EUTCD-grade lines?

In 2006 the European Tissues and Cells Directive (EUTCD) was introduced to…

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