FROM:     The Daily Record (Baltimore, MD)
 November 5, 2004 Friday
HEADLINE: Proposed legislation in Md. to ban one type of stem-cell
research
causes concern
BYLINE: Robyn Lamb

   A small Maryland biotech firm will soon release a report sure to fuel
the big
dreams of many Americans suffering from incurable diseases and conditions
such
as Parkinson's and paralysis.

   Using fetal-derived stem cells, Neuralstem Inc. recently helped
paraplegic
rats walk again. The Gaithersburg company intends to go public with
results of
its study in the next few weeks.

   "Once we publish, it will be clear that we're hitting something that
is
imminent for the future," said Richard Garr, Neuralstem's president and
chief
executive. "The debate [over stem-cell research] will be very different
when it
is not hypothetical."

   While Garr is obviously enthusiastic about the prospects of stem-cell
research, he and others are increasingly pessimistic about the role
Maryland --
one of the nation's top three biotech hotspots -- will play in the
promising,
yet highly controversial, field.

   The reason: Even as Californians were voting this week to create a
giant $3
billion fund to finance such research, Maryland lawmakers were preparing
legislation to ban an important type of it.

   "You'll see the entire country tilt toward California," warned Garr,
who
himself is considering moving his 8-year-old Montgomery County business
to the
West Coast.

   Considering how much Maryland is counting on biotechnology for its
economic
future, it's nearly impossible to exaggerate the impact such widespread
defections would have, leaving many to wonder and worry: Will they stay
or will
they go?

   Clear as plasma

   Despite the prominence stem-cell research took on during the
just-ended
presidential campaign, there is still considerable confusion about what
it is
and what President George W. Bush's ban really encompasses.

   Stem cells represent the building blocks of the human body. They can
both
convert into other types of cells and tissue and replicate themselves.

   Some scientists believe they can use stem cells to regenerate tissue
and
organs damaged by diseases such as diabetes and Alzheimer's, to repair
spinal-cord injuries, to create dopamine-producing cells that might cure
Parkinson's, and even to grow new organs to replace those that are
failing.

   There are two types of stem cells: adult and embryonic. Adult stem
cells are
harvested from a variety of sources, including umbilical cords, blood and
bone
marrow. Embryonic stem cells are of course harvested from embryos.

   Adult stem cells, many believe, do not have the same capacity for
renewal as
embryonic stem cells, are more limited in terms of uses, and are more
difficult
to grow in a dish. Scientifically speaking, embryonic stem cells seem to
be
superior.

   The controversy arises because harvesting cells from an embryo
requires the
destruction of that embryo, and many pro-life advocates view the
destruction as
murder.

   An opponent of abortion, President Bush limited public funding of
stem-cell
research to existing lines of embryonic stem cells. No other embryonic
stem
cells may be used in federally financed work. The prohibition spurred
complaints
from the scientific community that the president's permitted list is too
short
and includes many lines that are unusable.

   New arena

   Until recently, the fight over embryonic stem cells was taking place
exclusively at the federal level.

   But now state legislatures are taking it upon themselves to regulate
the
technology, which is a blessing or a monstrosity, depending on whom you
ask.

   More than 30 states have either passed or are considering stem-cell
legislation.

   During the 2005 session of the Maryland General Assembly, which starts
in two
months, a group of legislators will submit a bill that would impose a
total ban
on the cloning of human embryos for any purpose.

   That may seem to have little to do with embryonic stem cells, but it
does.
Scientists can create embryonic stem cells through a process called
nuclear
transfer or therapeutic cloning.

   Scientists scoop all the genetic material out of an unfertilized human
egg
and replace it with genes from an adult cell. The egg, stimulated by a
short
electrical impulse, develops into the blastocyst -- the early form of an
embryo.
From that, stem cells can be removed.

   This type of stem cell is the genetic match of its donor, meaning it
can be
transplanted into the donor whose cells are damaged by disease.

   The process is just a step away from so-called reproductive cloning, a
process most scientists do not condone. In reproductive cloning, the
embryo --
instead of being interrupted in the blastocyst stage -- is implanted in a
uterus
to produce a human clone.

   Nevertheless, lawmakers want all types of cloning banned. Maryland's
bill,
modeled after the federal Brownback Bill that has passed the House, would
make
human cloning a crime punishable by up to 10 years in prison and up to
$100,000
in fines. Violators could also face civil fines of $1 million or more.

   "There have always been " ethical problems that exist when independent
labs
and stuff come up with these new types of procedures," said the bill's
sponsor
in the House of Delegates, state Del. Curt Anderson, D-Baltimore. "You
get into
an area that might be ethically questionable. It [the bill] gives bright
lines
of what should and should not be done."

   Proponents of the bill argue a cloned embryo is a human even before
implantation in the womb and to destroy it for research, or "as repair
kits,"
would be immoral.

   "Asexual reproduction is wrong. It is abhorrent. It is immoral," said
Nancy
Fortier, an associate director of the Maryland Catholic Conference, a
group
created by the bishops of Maryland to advocate for the public-policy and
pastoral interests of the archdiocese of Baltimore, Washington and
Wilmington,
Del.

   "The term therapeutic cloning is a wrong term. The definition of
therapeutic
is that it benefits the subject, but when you harvest embryonic stem
cells, you
kill the subject," Fortier said. "It's a misnomer."

   Fortier, who spearheaded the effort to introduce the cloning ban in
the
Maryland General Assembly, fears that allowing the research to go forward
would
result in poor women being encouraged to sell their eggs for research.

   "Where do you think you're going to get these millions and millions of
eggs?
You exploit poor women," she said.

   And for what, asks David Prentice, a cell biologist who plans to
testify in
favor of the Maryland ban.

   "The key word here is the 'potential' benefit to others," Prentice
said.
"There is little evidence that they are going to ever treat a patient."

   So far, every cloned animal has had genetic problems, Prentice said,
adding
that in lab research on animals, embryonic stem cells have been known to
cause
tumors and tissue rejection remains a huge hurdle.

   "I'm not saying that you could never get a treatment. If you pour
enough
time, money and effort into it you might. But in the meantime you're
neglecting
what is working: adult stem cells," he said.

   Viable alternative?

   It is true, doctors have been transplanting adult stem cells found in
bone
marrow to treat blood disorders and cancer for decades. For example,
doctors can
transplant bone marrow stem cells back into patients who have lost
blood-forming
tissue during radiation or high-dose chemotherapy.

   Doctors at the Cedars-Sinai Medical Center in Los Angeles recently
treated a
middle-aged Parkinson's patient with his own brain stem cells, which they
extracted during a routine surgery. Doctors grew the stem cells in a
dish,
ultimately growing mature neurons, a certain number of which produced
dopamine,
a critical substance lacking in Parkinson's patients.

   Cardiac infarct, Chrohn's disease and various blood and skin diseases
are
among other illness treated. More recently, animal tests have shown that
adult
stem cells may have the ability to transform themselves into the cells of
more
organs than previously believed.

   In Baltimore, a team of researchers at the Johns Hopkins Kimmel Cancer
Center
this summer found stem cells taken from the bone marrow of mice developed
into
liver cells and helped restore liver function in mice with liver
injuries.

   The technique -- if proved effective -- could eventually be used to
treat
chronic diseases like diabetes, cirrhosis of the liver, heart disease and
cancer.

   Arguments against the potential of adult stem cells could hurt the
research's
development, some fear.

   "We don't know what our limitations are with adult cells, but we are
doing
more than we thought was possible. People who work on embryonic stem
cells
continue to say you can't use adult stem cells and that's probably not
good for
them either. A lot of those people are looking for funding so they say
that
adult stem cells don't work," said Mark Pittenger, vice president of
research at
Baltimore-based Osiris Therapeutics Inc., which is working to develop
treatments
with adult stem cells.

   After 12 years, Osiris is starting human trials using mesenchymal stem
cells
derived from bone marrow to treat the effects of chemotherapy and
radiation as
well as to improve heart function after heart attacks and heart disease.

   But neglecting embryonic research in favor of pushing adult stem cells
is
shortsighted and irresponsible, according to many research scientists.

   "The ethical issue to me is the slow rate at which we're moving to
cure these
diseases," said John Gearhart, a researcher at the Johns Hopkins School
of
Medicine and one of two scientists who first pioneered the isolation of
human
embryonic stem cells.

   "We have to step back and say, 'why are we doing this,'" said Chi
Dang, vice
dean of research at the Johns Hopkins School of Medicine. "We are doing
this
because, and I put this in quotations, 'the patient is waiting.' The
patient is
waiting for something new and in certain areas we have nothing to offer.
Our
moral obligation is to use science."

   Already a hub for stem-cell research, the university established the
Institute for Cell Engineering in 2001 with an anonymous donation of
$58.5
million. One of only a handful of such centers in the country, the
institute's
mission is to mold engineered human cells into therapeutic transplants
for
neurodegenerative diseases, spinal cord injuries, diabetes and heart
failure.

   "In some diseases, Lou Gehrig's for example, we're talking windows of
five to
10 years," Dang said. "We can't just say that adult stem cells are
efficient. In
five years, if we find out we're wrong, we're five years behind."

   Surely, the fledgling research on embryonic stem cells will take time.

   Neuralstem, for example, started out eight years ago trying to
cultivate
dopamine-producing cells for the treatment of Parkinson's. Initially the
company
could not get enough cells producing the chemical. By the time it did,
Neuralstem did not have the resources or the funds to continue the line
of
study.

   "People still think stem cells are going to become an outlaw
industry," Garr
said.

   But perhaps equally important, he added, many people have the mistaken
idea
that the research follows straight and efficient lines.

   "The popular myth around stem cells is that if it works, it's a magic
bullet
and it works immediately. It's not a one shot, rifle shot deal and to say
that
we're not close just because it hasn't happened is wrong."

   On the outside?

   With the debate in full swing, U.S. states and foreign countries
competing
with Maryland for biotech companies are forging ahead, spending billions
on
embryonic research. Britain, for example, sped ahead to become the first
nation
to legalize human cloning for research.

   In the United States, California is now poised to take the lead.

   This has Maryland's biotech community fearing a loss of its
competitive edge
in the field.

   "Certainly if I was a company and I was locating, I would go to New
Jersey or
California," said Curt Civin, professor of oncology and pediatrics at
Johns
Hopkins University School of Medicine's Sidney Kimmel Comprehensive
Cancer
Center.

   Civin, who invented an antibody that is now the standard for isolating
and
collecting bone marrow stem cells used in cancer therapy, is working with
embryonic stem cells these days to look at, among other things, how they
might
generate a good model for creating blood cells.

   Referring to a recent lecture he gave in Seoul, South Korea, Civin
said, "I
felt like I was tuning the picture on the television that I am going to
be
buying from them."

   "The world point of view of this is important. But from our own
selfish point
of view, there go the jobs and there goes the discovery," Civin said.

   Gearhart, who teaches at Johns Hopkins, said he is already seeing
heavy
recruiting of his students from California and beyond. In fact, two of
his
doctoral students have already made plans to move to Australia and
Britain.

   For Civin it is the research itself at this point that will lead to
treatments.

   "This doesn't have anything to do with transplanting the cells or
creating
limbs," he said. "The most important use of my own invention to purify
adult
stem cells has been the 10,000 papers published. The knowledge that has
come
from that has been far more important to science and patients than the
small
number of patients who have gotten treatment. And that is the way it will
be
with embryonic research."

   That's not necessarily true at Neuralstem.

   "For us, the main point is to get into humans and show we can cure a
disease,
" Garr said.

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