<b>September 18 2003</b> – The facilities for research-grade stem cells at the UK's stem cell bank are ready for use, but it will be several months before the same can be said of facilities for lines for therapeutic purposes, a London-based conference heard this week. The director of the new stem cell bank, Glyn Stacey, told the Medical Research Council's international stem cell conference that the first applications to deposit and access the research-grade stem cell lines are currently being processed.
But work on the facility for clinical grade stem cell lines, which could be used for the production of human therapeutic materials, is still ongoing.
The three clinical-grade laboratories, which will conform to EU pharmaceutical standards, should be finished next month and operational by early next year.
"There is a perception in some outside groups that you can set up a GMP [Good Manufacturing Practice]&#8211;grade facility in months, but it just doesn't work like that. We have done extremely well to get it up in 12 months," Stacey told The Scientist.
Applications to access or deposit stem cell lines will all go to the bank's high-level steering committee. The committee's decision will be informed by an independent scientific review of the research proposal, an assessment by the MRC secretariat, and a review of safety and technical issues by the bank itself. Stacey said the steering committee is currently considering allowing researchers the right to appeal if an application is rejected.
The application process will take some months while the bank finds its feet. But Stacey said this would improve. "Lord Patel, the chair of the steering committee, is very keen to speed things up, and I can see the process becoming really quite fast. But we have to accept there will be issues to resolve as we go along," he said.
There will be no restrictions as to which countries can use the bank, although they will be expected to abide by the bank's code of practice. Regardless of their own country's regulations, researchers will be expected to demonstrate that they have acquired appropriate ethical consent for any donated cell lines and that their research project has been ethically agreed before they access cell lines.
"We have to be careful with countries like the US," Stacey said. "If we supplied an embryonic stem cell line to a US group who were receiving government funding, we would be acting illegally. But of course, we could supply whatever we like to commercial companies in the US."
UK science minister, David Sainsbury, told delegates the United Kingdom's stance on stem cells "allows for potential breakthroughs in medical science, but only with a comprehensive and rigorous scheme of regulation and control."
Links for this article
S. Pincock, "UK's first human ES cell line," The Scientist, August 13, 2003.
http://www.biomedcentral.com/news/20030813/05/
The UK Stem Cell Bank, National Institute for Biological Standards and Control
http://www.nibsc.ac.uk/divisions/cbi/stemcell.html
Stem Cells: Shaping the Future, September 15&#8211;16 2003, London, England
http://www.livegroup.co.uk/stemcellsconference2003/index2.php
P. Hagan, "Stem cell forum launched," The Scientist, July 17, 2003.
http://www.biomedcentral.com/news/20030717/04/
P. Brickley, "US stem cell rules clarified," The Scientist, August 9, 2002.
http://www.biomedcentral.com/news/20020809/04/
M. Habeck, "DFG seeks to clarify stem cell rules," The Scientist, July 22, 2003.
http://www.biomedcentral.com/news/20030722/04/
E. Ungar, "There ought to be a law," The Scientist, June 25, 2003.
http://www.biomedcentral.com/news/20030625/02/
