Regulatory Focus™ > News Articles > MHRA Unveils 'Regulatory Ready' Stem Cell Lines

MHRA Unveils 'Regulatory Ready' Stem Cell Lines

Posted 27 February 2017 | By Michael Mezher 

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Monday said it is looking to boost the development of cell therapies through the availability of what it calls "regulatory ready" embryonic stem cell lines.

"The UK Stem Cell Bank (UKSCB) at the National Institute for Biological Standards and Control (NIBSC) is releasing its first stem cell lines suitable for development into novel cell-based medicines to researchers wishing to bring new and innovative therapies to clinical trial," MHRA said on Monday.

The stem cell lines are intended to serve as qualified starting materials for cell therapies looking to enter clinical trials.

"The availability of EUTCD [EU Tissue and Cell Directives]-grade human embryonic stem cell lines via the UKSCB provides an invaluable 'gold standard' starting material; ensuring high quality and ethically-sourced stem cells are widely available to the research community to use in human clinical studies," said Rob Buckle, chief science officer at the UK's Medical Research Council, which is a co-sponsor of the UKSCB.

The stem cell lines will be produced by a handful of UK-based universities and deposited at the UKSCB in compliance with the EUTCD, which establishes quality and safety standards for human tissue and cells.

According to the UKSCB, "EUTCD-grade cell lines undergo a process known as due diligence to ensure they meet the requirements of the EU Tissue and Cell Directives before they are accepted for banking and distribution for human application. The EUTCD-grade cell lines have been derived from embryos under the informed consent requirements of the UK Fertilisation and Embryology Authority (HFEA) and have been reviewed by an independent UK Steering Committee."

In the coming months, MHRA says that stem cell lines produced by the University of Sheffield, University of Manchester and King's College London will be made available, followed by additional stem cell lines from Newcastle University and Roslin Cells by the end of the year.


Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.