The world's first 'clinical grade' human embryonic stem cells have been donated to the UK Stem Cell Bank (UKSCB). The high quality cell lines are expected to become the gold standard for developing new cell-based therapies for serious medical conditions, including spinal cord injuries.
The cells are unique because, unlike 'research grade' cell lines, they have been created without the help of animal products, which are normally used to stimulate cell growth. These 'xeno-free' cells have been described as the 'holy grail' of regenerative medicine.
'We have succeeded where many substantial commercial companies have not', said researcher Professor Peter Braude of King's College London, UK. 'We had to get to the point where everything we're using is animal free, or in some way has been tested to be safe or its provenance known – you can't have something that has been exposed to pig, mouse or cow injected into humans. The 'holy grail' is where you start the [cell] line from the point where it is clean enough to be used for clinical therapy – all the ingredients are clean'.
Some research grade cell lines have previously been re-classified as clinical grade following a vigorous conversion process to remove all traces of animal products. Such re-classified cells are currently being tested in small safety trials but their use is highly restricted and the associated risks are deemed unacceptable for widespread human use.
The ten-year-long research was funded by the UK's Medical Research Council (MRC) and conducted to strict European ethical and quality standards. This means the cells could soon be made available to any European researchers who wish to use them. However, before this can happen the UKSCB will conduct a comprehensive series of tests to ensure the cells are safe for use in humans.
'These lines will be an important resource to fulfil our plan to make available a panel of characterised and tested clinical grade lines within the next three years. The process of testing will be rigorous and not all cells lines received will make the grade', said Dr Glyn Stacey, head of the UKSCB. 'The moment we release them they are ready for use in a clinical trial'.
Dr Rob Buckle, head of regenerative medicine at the MRC, added: 'The development of xeno-free human embryonic stem cells lines is a major step forward in the field as it paves the way for 'gold standard' clinical-grade cell lines suitable for use in humans'.