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US Stem Cell Researchers Chafe ... NIH Chief Zerhouni's Comments On Adequacy Of Available Lines Questioned
By Merrill Goozner

December 5, 2003

US stem cell researchers are questioning last week's assertion by National Institutes of Health director Elias Zerhouni
that the embryonic stem cell lines that have been made available to government-funded researchers are sufficient to
meet their needs.

Zerhouni's comments came in response to a recent study by a panel of medical ethicists, which suggested the 78 approved
lines, a dozen of which are now available for use, will never be used in human clinical trials. The main concern
expressed by the panel, which was organized by Johns Hopkins University and included scientists, philosophers, and
lawyers, was that human embryonic cells that have been amplified with murine feeder layers might contain unrecognized
contaminants.

Zerhouni said those concerns were overblown since no research has yet shown stem cells will be medically useful.
Moreover, the Food and Drug Administration has said it has adequate guidelines for human safety in clinical trials that
can be applied to those lines, he said.

“The feeling in the [stem cell research] community is that both those arguments are weak,” John Gearhart, a professor
of medicine at the Institute for Cell Engineering at Johns Hopkins Medical School and developer of one of the world's
first human embryonic stem cell lines, told The Scientist. “It's clear no one will use those lines in humans.”

The biggest fear among researchers is that mouse-fed cell lines, which include all the lines approved by President
Bush's August 2001 edict, may contain unidentified retroviruses that can cause havoc if they cross species. “Probably
none of those cell lines should go into clinical studies,” said Eugene Redmond, director of the Neural Transplantation
and Repair Program at Yale University School of Medicine. “Why spend money and waste time with a cell line that you're
not going to be able to use for therapy?”

Instead, the more ambitious researchers in the field are looking for alternatives to government funding so they will
not be limited to its approved cell lines. Harvard biologist Douglas Melton, whose two children suffer from type I
diabetes, announced at a major stem cell research conference held in Singapore in late October that he has developed 17
new embryonic cell lines that used human feeder layers. He has agreed to share the lines with other researchers.

His work on those lines, which were derived from embryos discarded by fertility clinics, was funded by the Howard
Hughes Medical Institute and the Juvenile Diabetes Research Foundation. “I am hoping that by providing more stem cell
lines without restrictions, we will encourage more research in the stem cell field,” he told the conference.
Transplanting pancreas islet cells made from human stem cells may one day free diabetes sufferers from taking insulin
or risking organ transplants and their attendant immunosuppressive drugs.

Redmond told The Scientist that he would like to have “one or more” of the lines cited by Zerhouni. “But I couldn't use
any of the resources in my other (government-funded) stem cell programs,” he said. “I would have to find another source
of money.” The US government is spending only $30 million per year on stem cell research, and stem cell research isn't
far enough advanced to draw much attention from the biotechnology or pharmaceutical industries.

The Bush administration's continuing restrictions are feeding a brain and resource drain, other researchers warned. The
Singapore conference where Melton unveiled his new cell lines was called to highlight that island's growing investment
in stem cell research as a way of boosting its biotechnology industry. One of the conference's other major surprises
was a decision by the New York–based Juvenile Diabetes Research Foundation to invest $3 million in the Singapore
program.

The University of California at San Francisco, which lost senior researcher Roger Pedersen to Cambridge University in
the United Kingdom in the immediate wake of the Bush decision, this past October announced a major grant from a private
philanthropist to shore up its stem cell research program. “Without private support, this nation's leading researchers
are drawn to continue their research elsewhere,” said Jeffrey A. Bluestone, the interim director of the school's
Developmental and Stem Cell Biology Program.

Links for this article

P. Recer, “Restrictions not slowing stem cell research, NIH says,” Contra Costa Times, November 28, 2003.
http://www.bayarea.com/mld/cctimes/news/7369217.htm

R. Lewis, “John Gearhart,” The Scientist, 16:64, December 9, 2002.
http://www.the-scientist.com/yr2002/dec/nprofile_021209.html

Eugene Redmond
http://info.med.yale.edu/psych/research/people/r/redmond.html

Roger Pedersen
http://www.ucsf.edu/pibs/faculty/pedersen.html

University of California, San Francisco, Stem Cell Research
http://www.ucsf.edu/research/stem_cells.html

Jeffrey A. Bluestone
http://diabetes.ucsf.edu/bios/bluestone.html

SOURCE: The Scientist /  BioMed Central News
http://www.biomedcentral.com/news/20031205/05

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