Scientists Chafe at Restrictions on New Stem-Cell Lines

The California Institute of Regenerative Medicine is rethinking its rules in the wake of a recent breakthrough involving the creation of stem-cell lines from a cloned human embryo

By David Cyranoski and Nature magazine

Many US centers prohibit research on embryonic stem cells. Image: OHSU Photos

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The announcement last month of a long-awaited breakthrough in stem-cell research the creation of stem-cell lines from a cloned human embryo has revived interest in using embryonic stem cells to treat disease. But US regulations mean that many researchers will be watching those efforts from the sidelines.

The US National Institutes of Health (NIH), which distributes the majority of federal funding for stem-cell research, prohibits research on cells taken from embryos created solely for research a category that includes the six stem-cell lines developed by Shoukhrat Mitalipov, a reproductive-biology specialist at the Oregon Health and Science University in Beaverton, and his colleagues. The team used cloning techniques to combine a donor cell with an unfertilized egg whose nucleus had been removed, creating a self-regenerating stem-cell colony that is genetically matched to the cell donor.

Mitalipovs cell lines are also off limits to researchers funded by the California Institute of Regenerative Medicine (CIRM), which was created in part to support stem-cell work that is restricted by the NIH. CIRM funds cannot be used for studies that pay women for their eggs or rely on cell lines produced using eggs from paid donors. That rules out Mitalipovs lines, because his team paid egg donors US$3,0007,000 each, says Geoffrey Lomax, senior officer to the standards working group at CIRM, which is based in San Francisco. That amount is above and beyond any out-of-pocket costs to donors, he says.

The end result, says Mitalipov, is that a dozen or so universities are struggling to negotiate material transfer agreements to receive the new cell lines without running afoul of CIRM or the NIH. Interest in the new cell lines is high, especially since the identification of errors in images and figures in Mitalipovs research paper shortly after its publication in Cell. But regulations would require laboratories to use only dedicated, privately funded equipment to study the new cells, a condition that only a fewresearchers such as George Daley, a stem-cell expert at Boston Childrens Hospital in Massachusetts will be able to meet.

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Scientists Chafe at Restrictions on New Stem-Cell Lines