NASA Light-Emitting Diode Technology Brings Relief In Clinical Trials, page 1

November 13, 2003
Michael Braukus
Headquarters, Washington
(Phone: 202/358-1979)

Jerry Berg
Marshall Space Flight Center, Huntsville, Ala.
(Phone: 256/544-0034)
RELEASE: 03-366

NASA LIGHT-EMITTING DIODE TECHNOLOGY BRINGS RELIEF IN CLINICAL TRIALS

A nurse holds a strange-looking device, moving it slowly
toward a young patient's face. The note-card-sized device
is covered with glowing red lights, but as it comes closer,
the youngster shows no fear. He's hopeful this painless
procedure using an array of lights will help ease or
prevent some of the pain and discomfort associated with
cancer treatment.

The youngster is participating in the second phase of human
clinical trials for this healing device. The first round of
tests, by Medical College of Wisconsin researchers at
Children's Hospital of Wisconsin in Milwaukee, was so
encouraging doctors have expanded the trials to several
U.S. and foreign hospitals.

"We've already seen how using LEDs can improve a bone-marrow
transplant patient's quality of life," said Dr. Harry
Whelan, professor of neurology, pediatrics and hyperbaric
medicine at the Medical College of Wisconsin. "These trials
will hopefully help us take the next steps to provide this
as a standard of care for this ailment."

The light is produced by light emitting diodes, or LEDs.
They are used in hundreds of applications, from electronic
clock displays to jumbo TV screens.

LEDs provide light for plants grown on the Space Station as
part of commercial experiments sponsored by industry.
Researchers discovered the diodes also had many promising
medical applications, prompting NASA to fund this research
as well, through its Marshall Space Flight Center in
Huntsville, Ala.

Biologists have found that cells exposed to near-infrared
light from LEDs, which is energy just outside the visible
range, grow 150 to 200 percent faster than cells not
stimulated by such light. The light arrays increase energy
inside cells that speed up the healing process.

In the first stage of the study, use of the LEDs resulted in
significant relief to pediatric bone-marrow transplant
patients suffering the ravages of oral mucositis, a common
side effect of chemotherapy and radiation treatments,
according to Dr. David Margolis, an associate professor of
pediatrics at the Medical College, working with Dr. Whelan
on the study at Children's Hospital.

Many times young bone-marrow transplant recipients contract
this condition, which produces ulcerations in the mouth and
throat, severe pain and in some cases, inflammation of the
entire gastro-intestinal tract. Chewing and swallowing
become difficult, if not impossible, and a child's overall
health is affected because of reduced drinking and eating.

"Our first study was very encouraging, and using the LED
device greatly reduced or prevented the mucositis problem,
which is so painful and devastating to these children,"
said Whelan. "But we still need to learn more. We're
conducting further clinical trials with larger groups and
expanded control groups, as required by the U.S. Food and
Drug Administration, before the device can be approved and
available for widespread use."

The treatment device was a 3-by-5-inch portable, flat array
of light-emitting diodes. It was held on the outside of a
patient's left cheek for just over a minute each day. The
process was repeated over the patient's right cheek, but
with foil placed between the LED array and the patient, to
provide a sham treatment for comparison. There was no
treatment of the throat area, which provided the control
for the first study.

The researchers compared the percentage of patients with
ulcerative oral mucositis to historical epidemiological
controls. Just 53 percent of the treated patients in the
bone-marrow transplant group developed mucositis,
considerably less than the usual rate of 70-90 percent.
Patients also reported pain reduction in their mouths when
compared to untreated pain seven days following bone marrow
transplant.

The clinical trials are expected to take approximately three
years with a total of 80 patients. Participants currently
include the Medical College of Wisconsin in Milwaukee;
Roswell Park Cancer Institute in Buffalo, N.Y.; and
Instituto de Oncologia Pediatrica, in Sao Paulo, Brazil.
Other domestic and international hospitals have asked to
join the multi-center study.

Quantum Devices of Barneveld, Wis., makes the wound-healing
LED device. The company specializes in the manufacture of
silicon photodiodes, or semiconductor devices used for
light detection, and light emitting diodes, for commercial,
industrial and medical applications.

Supporting materials, including photographs, for this
release are available on the Internet at:

http//www.msfc.nasa.gov/news