0823701 U.S. Approves Labs With Stem Cells for Federal Use
By NICHOLAS WADE
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.