Why the Senate should ease stem cell restrictions

Madison, Wis. - Dr. Jamie Thomson and his colleagues at Madison's WiCell Research Institute announced early this year they had developed two new lines of stem cells "fed" through a culture medium free of animal proteins. The breakthrough was hailed in scientific circles because it moved stem-cell research a step closer to clinical trials.

But there was a catch: Even though Thomson and others derived the new stem cell lines from previously approved colonies of cells, the new lines don't qualify for federal research funding under restrictions set by President Bush five years ago.

Loosening those restrictions will be the subject of a U.S. Senate vote this week on a bill, already passed by the House of Representatives, to allow scientists to use federal money to conduct research on new colonies of medically promising cells. The bill and two companion pieces of legislation would override rules put in place by Bush in August, 2001, that restricted federal funding only to those embryonic stem cell lines in place at the time.

The rights to some of those lines are held by the Wisconsin Alumni Research Foundation, a private, non-profit patent and license affiliate of the University of Wisconsin-Madison. It was WARF that created WiCell to continue stem cell research, using only those lines approved in 2001.

Bush's policy was aimed at protecting human embryos, but advocates say the net effect has been to slow basic research - historically conducted at major universities or federal labs - on uses of stem cells to diagnose, treat, or even cure chronic diseases. While research into adult stem cells continues, most scientists agree those cells lack the research potential of embryonic stem cells. Building blocks of life

Stem cells are the building blocks of human life; all organs and tissues "stem" from these basic cells. Given time and more resources, scientists believe stem cells will eventually yield knowledge that could help victims of diabetes, Alzheimer's, Parkinson's, spinal cord injuries, and heart disease, for example.

Opponents have dwelled on the fact that embryonic stem cells come from donated embryos produced by in-vitro fertilization clinics, which have been commonplace in the United States for more than 25 years. Such clinics help childless couple conceive, but excess embryos are produced in the process. While a few are frozen and stored, most are discarded. Stem cells used for research come from embryos that would otherwise be thrown away.

UW-Madison professor Thomson is renowned as the pioneer of human embryonic stem cell research; he was the first to keep such cells in a perpetual state. So when his team announced the creation of lines WA 15 and WA 16 in January, other researchers took notice. The discovery underscores why it's time to lift the 2001 restrictions.

By completely ridding the culture medium (a blend of nutrients, hormones, growth factors, and blood serum) of animal cells, stem cell research moved a step closer to clinical reality. Scientists are concerned that human stem cells grown in cultures that included animal cells might become contaminated with animal viruses or other agents. Now, it is possible to develop lines that could be used for therapy without fear of animal taint.

"Derivation and culture in serum-free, animal product-free, feeder-independent conditions means that new human cell lines could be qualitatively different from the original lines, and makes current public policy in the United States increasingly unsound," concluded a paper on the findings published early this year in Nature Biotechnology.

Much work remains to be done before Thomson and others fully understand the chromosome stability of stem cells during long-term culture, and that challenge cuts to the heart of current restrictions on federally funded stem-cell research. Researchers across the United States have called for opening up new stem cell lines for federal research funding because the older lines have been shown to accumulate genetic mutations. Those mutations don't prevent research, but they stand in the way of future clinical uses. New lines would also provide additional genetic diversity to the mix.

The Senate may pass the bill with a veto-proof majority, but a veto would be unlikely to stand up in the House. That's unfortunate. While researchers in other nations move ahead, researchers in the United States - where stem cells were first isolated - are fighting with one hand tied behind their collective backs. When politics trumps responsible science, ordinary people are often the losers.


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