Texas Heart(R) Institute at St. Luke's Episcopal Hospital Initiates First Clinical...

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Mon Apr 14, 2008 2:29pm EDT

Texas Heart(R) Institute at St. Luke's Episcopal Hospital Initiates First
Clinical Trial in the World to Treat a Heart Attack Patient with a Special
Stem Cell Type

HOUSTON, April 14 /PRNewswire-USNewswire/ -- Physician scientists at the Texas
Heart Institute (THI) at St. Luke's Episcopal Hospital announced they have
begun the world's first clinical trial to treat heart attack patients with a
special type of stem cell to promote better healing and to prevent congestive
heart failure, which many patients develop following a heart attack.

Almost six million Americans have congestive heart failure, a progressive form
of cardiovascular disease that inhibits the heart from pumping blood
throughout the body, and 550,000 new cases are diagnosed each year. About half
of these patients die within five years after receiving a diagnosis of severe
heart failure. 

Stem cell transplantation offers new hope for treating heart failure. Stem
cells are "generic" cells that can regenerate themselves and develop into
specialized cells, such as cardiac cells. In stem cell therapy, stem cells are
typically removed from another part of the patient's body -- usually the bone
marrow or the blood, both of which contain a variety of stem cell types. The
cells are then transplanted into the heart, where they can lead to the growth
of new heart muscle and blood vessels to replace damaged tissues. 

The special stem cells used in this study, known as mesenchymal precursor stem
cells, are allogenic, meaning that they have been taken from the bone marrow
of a healthy donor and grown in cultures to provide a plentiful supply. These
cells, which are injected directly into the heart with a special catheter,
appear not to provoke rejection by the recipient or cause inflammation. 

The first patient to receive the treatment is a 65-year-old man. The man's
heart attack was treated with angioplasty to open the obstructed vessel, and
he received a stent, a spring-like device, to keep the vessel open. He had the
stem cell procedure in the catheterization laboratory ten days after having
his heart attack, and he was discharged from the hospital two days after
receiving this experimental treatment.

"Our pre-clinical trials have established that ten days after the heart attack
is the optimal time to give this treatment. The heart is still inflamed in the
days just after a heart attack. If we wait too late, the heart will have too
much scar tissue and its ability to pump will already be compromised," said
Emerson Perin, M.D., Ph.D.  Dr. Perin is the director of the Texas Heart
Institute's Stem Cell Center and he was recently appointed Director of
Clinical Research for Cardiovascular Medicine at THI. 

This randomized Phase I trial will include 25 patients in three phases in
which the patient receives 25, 75 or 150 million stem cells. Physicians use a
3-D imaging technology which maps the electrical and mechanical function of
the left ventricle, the main pumping chamber of the heart. The stem cells are
injected into damaged but still viable areas of the heart muscle. The study is
sponsored by Angioblast Systems, a company which provides the proprietary
cells.

"This is a major milestone in the adult stem cell research we began eight
years ago. Our challenge remains to identify the very best types of stem
cells, refine our delivery techniques, and establish the most effective doses
of stem cells. We also have much work to do in understanding the molecular
mechanisms by which stem cells differentiate into specific organs and tissue,"
said James Willerson, M.D., president-elect and medical director of the Texas
Heart Institute at St. Luke's. He is also President of The University of Texas
Health Science Center at Houston.

Dr. Willerson made the point that every person is a product of two cells which
develop into billions of stem cells that have the innate ability to form our
bodies. 

"All of us have stem cells in our bodies, just not in sufficient numbers to
perform the healing we need. I believe we were meant to learn of the powerful
potential of stem cells and build on it. In the coming years, this could be an
accepted stem cell therapy at hospitals.  Ultimately, stem cell research could
give us the ability to regenerate whole hearts," said Dr. Willerson.

Drs. Perin and Willerson and their team have developed a network of several
hospitals to identify patients who may fit the criteria to be enrolled in this
trial.

"We're already seeing promising results from treating patients with severe
heart failure with their own stem cells. With this study, we hope to find a
way to help patients before they get so sick," said Dr. Perin.

For more information about this clinical trial or others underway at the Texas
Heart Institute, contact the Stem Cell Center at 866-924-7836 or email
stemcell@heart.thi.tmc.edu. There is also information on all the trials at
www.texasheart.org.


SOURCE  Texas Heart Institute

Kathy Watson of Texas Heart Institute, +1-832-355-6569,
kwatson@heart.thi.tmc.edu or Melinda Muse of St. Luke's Episcopal Hospital,
+1-832-355-3040, mmuse@sleh.com
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