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July 13, 2001
Therapeutic Cloning Advances Quietly
In Europe's Biotechnology Laboratories
By GAUTAM NAIK
Staff Reporter of THE WALL STREETJOURNAL

ALICANTE, Spain -- Before showing a visitor his lab one recent
night, Bernat Soria whispered a warning: "Some people don't know
what we're doing here and could get upset. So you can talk about
stem cells, but never use the word human embryo."

Less than 10 minutes later, Dr. Soria placed a petri dish under
a
microscope and there, floating in a reddish liquid, were cells
taken from a
human embryo. He pointed out how several
of these "stem cells" were already starting to become nerve
tissue. Others would later turn into heart tissue and beat even
while sitting in the petri dish.

Dr. Soria, along with a small band of scientists in Europe
and the U.S., are quietly approaching a momentous -- and
controversial -- moment in science: the harvesting of stem cells
from cloned human embryos to treat and perhaps cure diabetes,
heart disease and other ailments.

The process, known as therapeutic cloning, involves two steps:
cloning a human into an embryo, and then using the embryo's
stem cells to create fresh tissue that can be transplanted into that
person. Stems cells have the almost-magical ability to become
a variety of cells, including those that make up muscle, nerve
and heart tissue. Stem cells from a cloned embryo are particularly
desirable because they are less likely to be rejected by the person's
immune system.

The cloning goal was brought closer to reality this week after
a tiny biotechnology company, Advanced Cell Technology Inc.
of Worcester, Mass., said it had begun experiments to clone
a human embryo to obtain stem cells. But the second step --
creating useful tissue from human stem cells -- is a lot further
along, especially in Europe, where objections to such research
aren't as fierce as they are in the U.S.

In January, for example, Britain became the first nation to approve
therapeutic cloning, albeit with safeguards. Britain doesn't permit
"reproductive cloning," in which the cloned embryo would become
an actual baby. Scientists also need to obtain a license before they
can clone embryos for research, and the embryos must be
destroyed after 14 days.

The debate in Britain wasn't very contentious. Religious and
right-to-life groups lodged protests, and anticloning speeches
were made in Parliament. But they were drowned out by two
groups eager to bring therapeutic cloning to Britain: patients
suffering from debilitating diseases, and scientists seeking
to give Britain an edge in this new research area.

"When people think about human clones they think about
identical copies. They don't think about therapy," says
Dr. Soria, a physiologist at the University of Miguel Hernandez
who admires Britain's new law. "That's the new frontier."

Spain's law is less clear-cut, but Dr. Soria is pushing the
envelope as far as he can. His ambition is to use tissue
transplantation to find a cure for diabetes. So far, in an article
in a scientific journal, he claims to have cured diabetic mice.
Now he is trying to do the same with humans. His latest
accomplishment -- so far unpublished -- is coaxing a large
number of stem cells from human embryos to become insulin-
producing cells. If these cells were transplanted into a diabetic
patient, they would have the potential to cure the person,
Dr. Soria says. "Within three years, I should have a human cell
that produces and regulates insulin," he predicts.

Dr. Soria began working with stem cells in 1996. But he was
galvanized into action in early 1997, when researchers at the
Roslin Institute in Scotland introduced the world to Dolly the
sheep. By cloning a mammal, the Roslin scientists also gave
birth to the idea of cloning human embryos and harvesting their
stem cells.

In October 1998, Dr. Soria began a series of experiments. He took
stem cells derived from a mouse embryo, added various lab
chemicals, and converted the cells into insulin-producing cells.
Some months later, he transplanted the insulin cells into a diabetic
mouse. By the next day, the creature's blood glucose level had
normalized -- a sign that enough insulin was being produced.
Even a year later, he says, the mouse's glucose level was normal.

Dr. Soria met Peter Sharp, a Roslin Institute scientist,
at a physiology conference in Spain in September 1999,
and the two researchers began to talk about "nuclear transfer,"
the process that created Dolly. Dr. Soria said he wanted to try it
on humans in order to harvest stem cells.

It was a daunting challenge. Dr. Soria soon discovered that
cloning a human was going to be much harder than cloning
a sheep. In creating Dolly, for instance, the Roslin scientists
wasted more than 200 eggs. "If you're going to use 100 human
eggs you have to think twice," Dr. Soria says.

But Dr. Soria remained hopeful. He sent a grant application to
the Juvenile Diabetes Foundation under the heading,
"Therapeutic Cloning of Human Pancreatic Beta Cells."
The New York-based foundation agreed to give him $650,000
for a three-year project as long as he met two conditions: delete
the word "cloning" from the proposal, and abandon
nuclear-transfer research to focus on stem cells. The reasoning:
While human embryo cloning may be useful, it is only relevant if
scientists first figure out the mysteries of stem cells.

For his project, Dr. Soria picked an unusual partner: Cardion AG,
a Germany-based company with some of the toughest rules about
embryo research. Cardion had a technique that could kill one group
of cells in a lab culture while preserving another. Dr. Soria used
chemical agents to change human stem cells into insulin-producing
cells -- a significant 20% made the transformation, he says -- and
then used Cardion's system to destroy the others.

Dr. Soria plans to grow the remaining human insulin cells and,
by early next year, see if they can produce enough insulin to
cure a diabetic mouse. "If we end up with human
[insulin-producing] cells that can be transplanted into a human,"
he says, "we'd like to do it right away. ... It could happen in three
years."

One Step Forward, Two Steps Back
Scientists hope to use cloning for medical research, but many
countries ban the process altogether. Other nations, including
the U.S., have yet to pass clear legislation to govern how the
technology will be used.

Australia
Human reproductive cloning was forbidden by law last December;
embryo research is illegal in the state of Victoria.

United Kingdom
The British Parliament is the only legislative body that has
explicitly approved therapeutic cloning. Reproductive cloning
is banned. The creation of embryos for research purposes has
been permitted in the U.K. since 1990.

France
The 1994 "bioethics" laws forbid all human embryo research.
Last month, the government of Lionel Jospin dropped a proposal
to allow therapeutic cloning after President Jacques Chirac and
advisory groups objected.

Germany
The Embryo Protection law forbids all human embryo research,
but a new National Ethics Commission is studying whether to
change the law.

Japan
Passed a law in 2000 to ban reproductive cloning, but left the door
open for creating research embryos, including cloned embryos.

U.S.
Embryo research is forbidden with federal government funds.
Nine states (Fla., La., Maine, Mass., Mich., Minn., N.D., Pa., R.I.)
ban all human embryo research. Four states (Calif., R.I., Mich., La.)
have laws preventing human cloning.

Sources: LeRoy Walters, Georgetown University; Lori Andrews,
Chicago-Kent College of Law

Write to Gautam Naik at  [log in to unmask]

SOURCE: Wall Street Journal
http://www.wsj.com/

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