Stem Cells Used To Try To Save Patient's Legs
ScienceDaily (Jan. 23, 2008) —
A Northwestern University Feinberg School of Medicine researcher has
launched the first U.S. trial in which a purified form of subjects'
own adult stem cells was transplanted into their leg muscles with
severely blocked arteries to try to grow new small blood vessels and
restore circulation in their legs.
The first two subjects in the 20-site national trial recently
underwent the stem cell transplant process at Northwestern Memorial
Hospital.
Severely blocked arteries in the leg and sharply diminished blood
flow can result in wounds that don't heal, the breakdown of tissue
and gangrene. This painful condition is called critical limb ischemia
(CLI) and results in the amputation of more than 100,000 limbs every
year in the United States. It's a serious, emerging health problem
that affects 1.4 million people. An estimated 15 percent of the
population will have this disease by the time they reach age 70.
The Northwestern-
people with CLI around the country -- targets patients who have
exhausted all other medical options including angioplasty, stents and
bypass surgery to repair blocked circulation in their legs.
"They're at the end of the therapeutic road and they're ultimately
facing potential amputation," said Douglas Losordo, M.D., the Eileen
M. Foell Professor of Heart Research and principal national
investigator for the study. "This is hopefully a way to help them
avoid that."
Losordo is director of the university's Feinberg Cardiovascular
Research Institute and director of cardiovascular regenerative
medicine at Northwestern Memorial Hospital.
"The stem cells themselves can assemble into blood vessels," Losordo
said. "They can also secrete growth factors that stimulate and
recruit other stem cells to come into the tissue and help with the
repair. It's an amazing biology we're trying to leverage in these
folks."
He said preclinical studies transplanting stem cells into the limbs
have shown this approach to be effective in mice and rats. "Based on
that, we think it has a good chance of helping humans," Losordo noted.
"This is a dreadful disease in which the profession has failed to
offer much in the way of relief for these patients," Losordo
said. "We're hoping this will have some impact."
Critical limb ischemia is the result of advanced peripheral artery
disease, which affects about 10 million people in the United States.
In peripheral artery disease, people develop blockages in their
arteries and vessels that slow or stop the blood flow to their legs.
When they have pain at rest in their lower legs and wounds on their
legs or feet that will not heal, the condition is called CLI. If left
untreated, CLI can result in a patient having toes, a foot or even a
leg amputated.
As CLI progresses, people begin to experience pain when they walk,
then when just sitting. The worst pain is at night because blood flow
is decreased when people lie down. Some have to sleep in chairs to
aid the blood flow and lessen the pain.
"Peripheral artery disease is a big health problem," Losordo
said. "There is an emerging awareness of this disease on public
health."
High blood pressure, high cholesterol, smoking and diabetes all raise
the risk of having the condition. But some people don't smoke, have
diabetes or high blood pressure and can still have blocked arteries
in their legs, Losordo said.
For the randomized, double blind, placebo-controlled trial, Losordo
uses the subject's own purified stem cells. The subject first takes a
drug for five days to stimulate the release of his or her stem cells,
called CD34+ cells, from bone marrow. An intravenous line is then
inserted into a subject's vein to collect blood through a machine
that removes a population of blood cells that contains the CD34+ stem
cells. Losordo further selects and enriches the cells to select only
CD34+ cells.
Losordo's study is supported by Baxter Healthcare Corporation, which
manufactures the Isolex 300i Magnetic Cell Selection System machine
used in this investigational study. The Isolex 300i Magnetic Cell
Selection System, which is approved for use in oncology patients,
purifies the subject's stem cells to provide only the CD34+ stem
cells. Losordo is also a paid consultant to Baxter.
Adapted from materials provided by Northwestern University.
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StemCells subscribers may also be interested in these sites:
Children's Neurobiological Solutions
http://www.CNSfoundation.org/
Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123
The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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