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Monday August 27 08:51 AM EDT
U.S. Approves Labs With Stem Cells for Federal Use
By NICHOLAS WADE  The New York Times

The National Institutes of Health (news - web sites) will announce
the names today of 10 organizations that possess stem cells eligible
for use by federally financed researchers.

The National Institutes of Health will announce the names
today of 10 organizations that possess human embryonic
stem cells eligible for use by federally financed researchers.

The list has been keenly awaited by scientists since Aug. 9,
when President Bush announced that the federal government
would finance research on such cells — which are created by
destroying human embryos left over from fertility treatments —
but only with cell cultures established before that date.

Some biologists expressed considerable skepticism at the time
that as many as 60 cell cultures had been established, as the
administration said was the case, because only a handful had
been described in the scientific literature.

According to a document made available to The New York
Times, there are 10 universities and companies that derived
cell cultures from 64 embryos before the cutoff date, and that
have told the National Institutes of Health they will make the
cells available to researchers.

The list includes four organizations in the United States and
six in Sweden, Australia, India and Israel.

As to the quality of the embryonic cells, another issue that
has worried many scientists, the agency says there is not yet
any agreed-upon standard. But it said most of the cells were
known to have the right set of proteins, or "markers," on their
surfaces, and to be capable of developing into the three
separate tissues of the early embryo.

Scientists hope that embryonic cells can be used to regenerate
the tissues damaged in diabetes, Alzheimer's, Parkinson's,
heart disease and other diseases.

Though the stem cell colonies were all derived from embryos
left over from in vitro fertility treatments, opponents of abortion
have condemned the research because it requires destruction of
the embryos from which the cells are derived.

But despite President Bush's months of agonizing over these
objections, his administration now appears eager to push ahead
with the research as quickly as possible. The National Institutes
of Health, the document says, will "ensure that the scientific
community has an opportunity to fully and swiftly investigate
the promise of human embryonic stem cell research."

The N.I.H. is part of the Department of Health and Human
Services. Tommy G. Thompson, the department's secretary,
has long been regarded as a supporter of this research.

The agency says it will make a registry of human embryonic
cell lines available on its Web site as soon as possible.
Until it does so, scientists will be uncertain whether the cells
will be available in sufficient quality and without excessive
restrictions.

Dr. Paul Berg of Stanford University, a leading biologist who
was consulted by the administration, said that until the registry
is posted, "it's hard to comment on where things stand." But,
he added: "In my view if we have 60 lines that's an enormous
opportunity. I think some of the fuss about whether the cells
are suitable for therapeutic use is simply premature. I suspect
it will take three to five years before anyone is ready to propose
a clinical trial."

Dr. Michael Ross, chief executive of CyThera, a San Diego
company that has derived cells from nine embryos in the hope
of curing diabetes, said his scientists needed to study and
understand the cells better before making them available to
others.

The organizations that have derived the human embryonic
stem cell lines, and the number of different embryos reported
in each case, are:

BresaGen, Athens, Ga. (4);

CyThera, San Diego (9);

the Karolinska Institute, Stockholm (5);

the Monash Institute of Reproductive Biology,
Melbourne, Australia (6);

the National Center for Biological Sciences,
Bangalore, India (3);

Reliance Life Sciences, Bombay (7);

the Technion-Israel Institute of Technology, Haifa (4);

the University of California, San Francisco (2);

Goteborg University of Goteborg, Sweden (19);

the Wisconsin Alumni Research Foundation,
or WARF, of Madison (5).

Researchers have expressed concern that the Geron
Corporation of Menlo Park, Calif., which financed the first
derivation of human embryonic stem cells at the University
of Wisconsin, might control access to the cells or impose
unacceptable conditions on their use. But Geron is only a
licensee, though an important one, of the patent held by
WARF, which has said it wants to make the cells widely
available. The only restrictions are that the cells should
not be made into viable embryos or used for human cloning.

Carl Gulbrandsen, the managing director of WARF, said
yesterday that he was negotiating with the N.I.H. over the
terms under which the foundation's cells would be made
available to the agency's researchers, and that "both of us
are pretty confident that this will get done soon and that
scientists are going to be happy with it."

Some scientists fear that WARF's patent will give it a
dominant position, but Mr. Ross of CyThera said his
company's lines were derived by an independent method.
Mr. Gulbrandsen said that any discussions between the
foundation and other derivers over commercial applications
needed not affect the distribution of cells to academic
researchers. He said that he hoped to reach a research-friendly
agreement with the N.I.H., and that if other derivers of the cells
did the same, "they don't have to worry about our patents."

An administration official said yesterday that the impending
publication of the embryonic cell registry "should put a lot
of the skepticism to rest."

"Basically it's time to go to work and start doing some of the
research," the official said.

SOURCE: Yahoo Daily News / The New York Times
http://dailynews.yahoo.com/h/nyt/20010827/ts/u_s_approves_labs_with_stem_cells_for_federal_use_1.html

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