US-based scientists working on embryonic stem cell (ES cell) research are relieved that the most important cell lines in their field have been approved for research by new government guidelines.
During the Bush administration, US government funding for research involving ES cells was restricted to just 20 cell lines, all of which were in existence before 9 August 2001. The Directive to this effect, passed by George W Bush in 2001, was repealed by the Obama administration in March 2009.
Executive Order 13505 ('Removing Barriers to Responsible Scientific Research Involving Human Stem Cells'), was supposed to facilitate future work but it also introduced much more strict guidelines regarding obtaining consent for donation of cells from embryos. Numerous cell lines had been obtained using various different consent procedures, so a panel was set up to verify which lines could be said to fall within the new guidelines. In the meantime, federal funding for research involving those cell lines was halted.
Serious concerns were raised about disruption to research involving five cell lines from the nonprofit WiCell organisation at the University of Winsconsin in particular. All five were previously approved but fell foul of the new regulations.
The H1 cell line, derived from an embryo donated by patients of a Winsconsin IVF clinic, was approved in January 2010. The H7, H9, H13 and H14 lines were only approved under the new rules at the end of April 2010. The delay was due to them being generated in institutes in Israel; finding the consent forms and translating from Hebrew to English took considerable time. The H9 cell line alone made up almost 40 per cent of orders from the now defunct National Stem Cell Bank, and was used for studies in over 500 journal publications.
The US National Institutes of Health (NIH) also recently approved nine other cell lines, bringing the total number in the NIH Stem Cell Registry to 64, according to the Washington Post. There are still 100 other cell lines waiting to be approved.
There was some criticism aimed at the delays introduced by the new bureaucracy, but NIH Director, Francis S Collins, said that the 'action should provide welcome reassurance to the many researchers who have been working on lines developed in the early days of stem cell research. Scientists can continue their studies without interruption, and we can all be assured that valuable work will not be lost.'