FROM: The Associated Press State & Local Wire
March 18, 2002, Monday, BC cycle
HEADLINE: UK announces innovative experimental treatment for Parkinson's
BYLINE: By STEVE BAILEY, Associated Press Writer
DATELINE: LEXINGTON, Ky.
" Researchers at the University of Kentucky are set to begin an
innovative
clinical trial of a device they believe can reverse the degenerative
neurological effects of Parkinson's disease.
The device is an implantable pump that delivers a naturally occurring
protein
that helps grow dopamine neurons in the brain, by catheter directly into
the
part of the brain that is damaged by Parkinson's.
Current treatments of Parkinson's focus only on improving the symptoms
of the
illness but do nothing to actually restore function to the parts of the
brain
ravaged by the disease, Greg Gerhardt, director of the school's Morris K.
Udall
Parkinson's Disease Research center of Excellence, said during a news
conference
Monday to announce the trial.
Parkinson's disease is a neurological condition most often seen in
older
people that progressively destroys brain cells and impairs control of
body
movement and speech.
Symptoms of the disease include tremors, stiff limbs, slow or absent
movement, a lack of facial expressions a shuffling gait, stooped posture,
depression and, in some cases, an impaired ability to think.
According to the National Institute of Neurological Disorders and
Stroke,
Parkinson's disease affects more than 500,000 and as many as 1 million
Americans. It is estimated that 20,000 Kentuckians have the disease.
The protein being used in the study is called Gail cell line-derived
neurotrophic factor (GDNF).
"GDNF is a very important compound in our world," Gerhardt said. "In
animal
models, we've shown that the direct infusion of GDNF into the section of
the
brain affected by Parkinson's can actually restore function to brain
cells that
are damaged or dying."
The study is a Phase I clinical research trial, meaning that
researchers
primarily will be investigating the safety of the device on participants.
Researchers will be looking for 10 subjects who will have the device
implanted and then studied for side effects or any other irregularities.
"The patients will be studied for about nine months after the pump and
catheter are implanted," said principal investigator Dr. John Slevin, a
professor in the UK College of Medicine's Department of Neurology. "Once
we
prove that it is safe, we will expand the study to look more closely at
its
efficacy, how it actually works."
GDNF is found naturally in the human brain but tends to decrease as a
person
ages. It is believed that the destruction of dopamine neurons, which are
aided
in growth by the protein, causes the symptoms of Parkinson's disease.
Laboratory studies have shown that GDNF both protects and promotes
regeneration of injured dopamine neurons and may directly influence the
degenerative disease process.
"Basically, what we're trying to do is improve, or even restore,
normal
circuitry in the brain that has been cut off by Parkinson's," said Don
Gash, a
professor in the college's Department of Anatomy and Neurobiology.
"We've seen very profound improvements in motor function of animals
who had
shown symptoms of late-stage Parkinson's. We have actually seen that
injured
neurons that have shrunk grow back to normal size range when treated with
GDNF."
The battery-powered pump, about the size of a small yo-yo and
refillable, is
implanted into the abdomen of the patient with a tiny tube connecting it
with a
small catheter in the brain.
The pump's programmable computer precisely regulates the flow of a
four-week
supply of GDNF directly into the brain via the catheter.
The pump currently is approved for delivery of drugs directly to the
fluid
around the spinal cord in patients with some conditions and the delivery
of
chemotherapy agents to treat colorectal cancer that has spread to the
liver.
The Udall Parkinson's Research Center is one of only 11 such centers
in the
nation.
The foundation for the new investigational treatment came from basic
research
done by Gerhardt and Gash at the center, and the trial is being funded by
a $5
million grant from the National Institute of Neurological Disorders and
Stroke,
a division of the National Institutes of Health."
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