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Wednesday, September 29, 2010 // The Statement B
months until they complete phase one
of the trial, and it's uncertain how long
phases two and three may last. And
after researching ALS for the last 20
years, Feldman wants to get it right.
HOW THEY GOT HERE
It wasn't long ago, however, that
researchers like Feldman couldn'ttouch
stem cells without fear of landing in jail.
Before the passage of the Michi-
gan Stem Cell Amendment - a bal-
lot initiative referred to as Proposal
2 - in November 2008, fertility clinics
were forced to throw away unwanted
embryos. The 53-47 voter approval
gave women in the state the opportu-
nity to donate their unwanted embryos
to research. The proposal also permit-
ted the creation of new embryonic stem
cell lines to study diseases and allowed
University researchers to transfer their
work to the state.
Before the proposal passed, Feldman
worked three months out of the year in a
lab at the University of California at San
Diego. Feldman said she made "great
strides" in California, where she laid the
groundwork for her current ALS clini-
cal trial.
"But it was difficult managing a labo-
ratory nearly 3,000 miles away," she
said. "It slowed progress and added
unnecessary costs."
Besides Election Day, March 9, 2009
stands out as an equally important day
for most University researchers. On
that Monday, the University announced
the opening of the A. Alfred Taubman
Medical Research Institute Consortium
for Stem Cell Therapies - a $2 mil-
lion center housed in the BSRB where
University researchers can develop
new stem cell lines. Earlier that morn-
ing, President Barack Obama issued an
executive order that would lift restric-
tions on embryonic stem cell research.
His announcement overturned former
President George Bush's executive
orders that limited stem cell research
and funding.
"This is a great day for America, and a
great day for science, and a great day for
the University of Michigan," Morrison
said in an interview with The Michigan
Daily at the time.
Today, Feldman calls Obama's deci-
sion "a huge triumph for anyone inter-
ested in medical science."
"It means we can obtain funding for
research that will eventually lead to eas-
ing the suffering of millions of people
afflicted with currently untreatable dis-
eases," she said.
Before the Michigan Stem Cell
Amendment passed, University
researchers were only allowed to use
human embryonic stem cell lines that
had been derived outside of Michigan.
Morrison said the regulation posed
major problems for research because
groups of people like African Ameri-
cans, Native Americans and indigenous
populations from North and South
America were underrepresented in
these lines.
"The existing embryonic stem cell
lines that had been derived in other
states don't come close to mirroring the
diversity that's present in our society,"
Morrison said.
More than a year and a half old, the
consortium is one of a few centers
ing research that creates or destroys
embryos.
The U.S. Justice Department is cur-
rently appealing the decision that Mor-
rison called a "nuclear bomb" for human
embryonic stem cell research.
"It's a far more extreme position than
we've ever encountered before," Morri-
son said. "If that injunction remains in
place for a significant period of time, it
will destroy the field because there will
be no federal support."
Wicha also said the injunction is "a
big blow" for stem cell research in the
United States. If the ruling isn't over-
turned, he said, scientists will take their
work outside the country.
Last year, the National Institutes
of Health gave $6.8 million in stimu-
lus funds to 13 stem cell research proj-
ects at the University. But at least five
NIH grants for projects related to the
treatment of human diseases will be
suspended this year if the injunction
"If I'mG going to spend years of mly life trying
. p,.e
to an swer a q ue stion, I really wa nt people
to Care what the answer is"
is dangerous for researchers because it
requires them to list their names and
addresses.
"Giving information about the
researcher allows some person with a
gun and a grudge to come to the lab and
start shooting," he said.
Any violation of the law would be a
felony, punishable up to five years in
prison. There would also be a $5,000
fine for failure to submit a report or
obtain written consent from an embryo
donor.
Goldman, who has analyzed the stem
cell legislation and has written recom-
mendations to Congress, said these
additions create a "chilling effect" that
will deter researchers from studying
stem cells.
"Why would someone want to do this
research with a possible felony charge
hanging over their heads if there was a
bookkeeping error?" he said.
According to Goldman, no state that
permits stem cell research requires the
amount of documentation proposed in
the bills, nor do any states impose sig-
nificant monetary fines for violations.
If passed, the amendments may
intimidate researchers and force them
to again move their work to one of the
other 45 states that allow stem cell
research, Goldman explained. He added
that this would only worsen Michigan's
"brain drain" and destroy the opportu-
nity for economic gains.
The 2008 Michigan Stem Cell Eco-
nomics Study, sponsored by the non-
partisan public policy institute The
Michigan Prospect, found stem cell
research could add nearly 4,000 new
jobs in the state. University Regent Oliv-
ia Maynard (D-Goodrich) is president
of The Michigan Prospect.
The study also reported that stem
cell research has the potential to treat
more than 770,000 Michigan residents
who suffer from diseases like diabe-
tes, ALS, Parkinson's and Alzheimer's.
For patients who often take time off
from work, stem cell therapies have
the potential to cut down sick days
and increase employee productiv-
ity. According to the study, if annual
employee absences decreased 2 per-
cent, the state would generate $19.2
million each year. Over 30 years, this
would total $576 million.
See STEM CELLS, Page 8B
* ta 5 a.m. and Eva Feldman is head-
ing to her office to devour a hearty
breakfast of scientific articles. Over
the next two hours she'll sample a bit of
cell biology, molecular biology and, her
favorite, neurodegenerative diseases.
By 8 a.m. Sean Morrison and Max
Wicha arrive, and all three begin
the tedious task of responding to the
hundreds of e-mails they've received
through the night. As the morning pro-
ceeds they visit their respective labora-
tories, which house not only their life's
work but also "their people," without
whom there would be no work at all.
The three, all top scientists at the
University, make up some of the prin-
cipal players in the most innovative
research in the world. Trying to solve
more than simple scientific questions,
they are on a mission to cure the most
torturous and fatal diseases that strike
mankind.
Wicha runs the University's Com-
prehensive Cancer Center. Morrison
directs the University's Center for
Stem Cell Biology Research as well as
the International Society for Stem Cell
Research. When they're not on cam-
pus they can most always be found in
Washington, D.C., Europe or Asia, pre-
senting their research at conferences
or meeting with international col-
leagues - Morrison traveled 135,000
miles least year alone.
But Feldman's day, it seems, can be a
bit more hectic.
On Tuesday she can be found in the
Neurology Clinic. Wednesday she's in
the Motor Neuron Disease-ALS Clinic
treating patients. Other afternoons
she's directing the A. Alfred'Taubman
Medical Research Institute.
For Morrison, Wicha and Feldman,
time is their enemy. While they're
barely afforded enough of it to breath,
the real challenge is working against
the clock to develop treatments that
may ease the pain and save the lives of
millions of people.
The answer, they believe, lies in
stem cells - microscopic units pres-
ent in all multi-cellular species that
can regenerate and morph into dif-
ferent cells, tissues and organs. While
scientists believe stem cells have the
potential to treat dozens of diseases
and conditions like Alzheimer's, diabe-
tes and spinal cord injuries, no one yet
knows their full potential.
And as researchers try to find out,
the clock keeps ticking.
"It takes years of your life to answer
a scientific question," Morrison says.
"So if I'm going to spend years of my
life trying to answer a question, I real-
ly want people to care what the answer
is."
Feldman doesn't mind the life com-
mitment that eats up her days, hours
and seconds.
"I don't really have a job,' " she
said. "I have a passion. And if you want
to call it a job, it's the best job in the
world."
CLOSE TO A CURE
In a laboratory on the fifth floor
of the Biomedical Science Research
Building, 30 students, Ph.D.s and life-
long researchers work ferociously to
find a treatment for a ruthless disease
- one that creeps through the body,
weakening tissues so that victims are,
quite literally, unable to move a mus-
cle. Even the seemingly most invinci-
ble athletes don't sta-d a chance.
Meet amyotrophic lateral sclerosis
- more commonly known as ALS - or
Lou Gerhig's disease, named after the
legendary New York Yankees baseball
player who suddenly came down with
the disease at the height of his career.
ALS damages nerve cells and motor
neurons in the spinal cord that control
muscle movement. The disease tends
to strike people in their 30s and 40s,
and once a patient is diagnosed it may
take only three to five years for the dis-
ease to take over the body and kill its
host. It's a painful process - as most
victims lose the ability to walk, talk
and even breath.
Feldman, who has seen thousands
of ALS patients die from the currently
untreatable disease, is on a medical
mission to find a cure.
"I would say on a near-weekly basis
one of my patients will pass away from
this disease," she said. "I am very
impassioned about understanding
ways and means to develop new treat-
ments."
The 30,000 people in the United
States diagnosed with ALS have reason
to remain hopeful, however, because
Feldman claims she's not too far from
a potential cure.
In January, Feldman started the
first human clinical trial approved by
the U.S. Food and Drug Administration.
to apply stem cells to treat ALS. Five
ALS patients have since volunteered to
receive injections of neural stem cells
into their spinal cords. Researchers at
the University of Michigan study and
approve the cells before shipping them
to Atlanta where the patients undergo
the stem cell transplants at Emory Uni-
versity.
The majority of the work occurs in
Feldman's lab in the Biomedical Sci-
ence Research Building, where bottles
of solutions, petri dishes and test tubes
clutter shelves and rows of DNA-filled
refrigerators line the hallways.
"I've got more refrigerators than
I have shoes," Feldman joked while
strutting down a corridor lined with
white refrigerators.
The trial is still in its first phase and
can only move onto phase two when
researchers prove the injections cause
no harm to the patients. Once safety
is established, Feldman and her team
will enter the next phase, where they
will watch to see if the stem cells actu-
ally benefit patients by slowing the
progression of the disease. If success-
ful, Feldman can recruit more patients
for phase three, which, she said, must
confirm both safety and efficacy.
The goal is to enter 18 patients in
the trial, which is receiving stem cells
and funding from Neuralstem Inc., a
biotech company in Rockville, Md. In
an interview in July, Feldman said she
was not allowed to comment about the
five current patients in the trial. How-
ever, she spoke with optimism as she
relayed her progress, noting she antici-
pates no trouble finding the remaining
volunteers.
"I think the one really amazing
thing about this patient population is
how willing they are to step forward
and really do something that is brand
new, that is clearly experimental - it
has never been done before - and they
realize that it may not necessarily
help them, but it will potentially help
other patients with the disease in the
future," she said.
Feldman believes it may be 14
in the nation where researchers can
derive new human embryonic stem cell
lines. Since Proposal 2 passed, donated
embryos have been slowly trickling
through the door.
According to Gary Smith, co-director
of the Consortium for Stem Cell Thera-
pies and an associate professor in the
Department of Obstetrics and Gyne-
cology, the consortium has received
approximately 20 donated embryos
from four couples.
THE CONTROVERSY ISN'T OVER
Though voters approved the 2008
ballot initiative, the fight to impose stem
cell research restrictions in Michigan
and across the country continues.
In August, U.S. District Court Judge
Royce Lamberth issued a ruling that
blocked federal funding for human
embryonic stem cell research. Lam-
berth decided that Obama's March
2009 statement violated the Dickey-
Wicker Amendment - a federal law that
prohibits the government from fund-
remains in place, according to Morri-
son, who testified before the U.S. Senate
this month about how to change federal
law to prevent the judge from blocking
funding.
As researchers await a final decision,
the U.S. Court of Appeals ruled yester-
day that the government can continue
funding human embryonic research
while the appeal is pending.
Meanwhile, the Michigan state Sen-
ate passed a bill in April that amends the .
stem cell research guidelines spelled out
by Proposal 2. The bill, currently being
reviewed by a state House of Represen-
tatives committee, proposes new docu-
mentation requirements that mandate
researchers to write reports about each
donated embryo - tracking informa-
tion about when it was received, what
research was performed and the out-
come of any experiments.
Ed Goldman, an associate profes-
sor in the Department of Obstetrics
and Gynecology and an opponent of
the legislation, said this type of report
Top Photo: JED
MOCHDaily
Bottom photos
from tuft to
right: courtesy
of Sue OShe
MARISSA
MCCLAIN/
Daily,. JED
MOCH/s L
MARISSA
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Daily