A biotech company based in Singapore has produced the first human embryonic stem cell (ES cell) lines specifically designed for clinical use. The cell lines have been developed using the principles of 'Good Manufacturing Practice', which describe how pharmaceutical products ought to be manufactured to minimise contamination under carefully controlled laboratory conditions. The cells do not rely on any animal products, unlike most established ES cell lines which are grown on mouse 'feeder' cells. The presence of any animal products could trigger an immune response if transplanted into humans. ESI, the company that has derived the new cell lines, plans to make two grades of cells available - a 'research grade' line which will be provided for a modest fee to cover administrative costs, and a more expensive clinical grade line. The company's objective is to generate enough interest in the research cell lines such that a demand will be created in the future for the more expensive clinical grade sibling lines.
Regulatory agencies have not yet defined what standard ES cell lines would need to achieve to be used in human trials. Peter Andrews of the University of Sheffield and Head of the International Stem Cell Consortium, admitted that this may be a problem but that it is, 'the nature of the beast. They say 'tell us what you've got and we'll tell you whether it's OK'. A second company Geron, based at Menlo Park, California, has also been working to produce embryonic lines suitable for clinical trials once a therapeutic use for the cells has been established. Unlike ESI, who have derived new lines from blastocysts provided by a Sydney embryonic stem cell clinic, the US company has purified well-characterised cell lines that, as they were derived before 2001, are registered for use with federal funds. The H1 and H9 cell lines have been cultivated free of animal cells for a number of years and 'have passed every single test that the regulatory agencies mandate for human use', said Tom Okarma, Geron's president and Chief Executive. The company plans to apply for FDA approval to begin clinical trials on glial cells derived from the lines in 2007.