Amit Patel Pioneers Heart Repair With Stem Cells

By Francis C. Assisi
INDOlink

27 September 2005 -- For the first time, scientists have
discovered that injections of bone marrow stem cells can
help rebuild weakened heart muscle, thanks to a technique
pioneered by Dr. Amit Patel, one of the leaders in stem
cell therapy for heart disease, at the University of
Pittsburgh Medical Center.

Stem cells are primal undifferentiated cells which retain
the ability to differentiate into other cell types. This
ability allows them to act as a repair system for the
body, replenishing other cells as long as the organism is
alive. Medical researchers believe stem cell research,
also called regenerative medicine, has the potential to
change the face of human disease by being used to repair
specific tissues or to grow organs. Still, as government
reports point out, "significant technical hurdles remain
that will only be overcome through years of intensive
research."

Patel is director of the Center for Cardiac Cell Therapy
at UPMC and the University of Pittsburgh McGowan
Institute for Regenerative Medicine and is making the
news these days with his pioneering work. .

For example, recently, it was discovered that a
Pennsylvania woman with heart failure has significantly
improved after undergoing a stem cell treatment in
Thailand via the direct injection technique pioneered by
Dr. Patel.

Jeannine Lewis suffered from non-ischemic cardiomyopathy.
She was in Class III-IV heart failure (the borderline of
needing a heart transplant) and on maximal oral medical
therapy. After three months, MRI and echocardiogram
results showed improvement and doctors have reclassified
her to Class I heart failure – a significant improvement.
Her shortening fraction and stroke volume have also
increased.

In May Lewis became the first patient in the world to
receive therapy using minimally invasive, direct cell
injections to the heart. Dr. Patel accompanied Lewis to
Bangkok in order to oversee her procedure.

Post-treatment, Lewis was in less pain and her exercise
tolerance had increased greatly, "within weeks, my
symptoms had greatly decreased while my energy level
simultaneously increased. I am now able to clean my
house, do my shopping and actively care for and play with
my young child." Lewis said. The recent quantitative test
results now confirm what Lewis seems to have known from
the beginning.

It's unclear if the stems cells used in the UPMC trials
might become transformed into new heart muscle tissue or
instead fuse with the patients' own damaged cells to help
them work better. Alternatively, the stem cells could act
like homing signals to attract other repair substances to
the heart.

Last month, Dr Patel launched a second clinical trial to
see if injections of bone marrow stem cells can improve
the function of a weakened heart.

The trial will involve patients with ischemic heart
disease who are scheduled for off-pump (beating heart)
coronary artery bypass grafting surgery. In addition to
assessing the safety and feasibility of using a patient's
own stem cells as a potential therapy for heart disease,
researchers also will be trying to determine just how
many stem cells are needed to produce the best results.

Patients who give their consent to participate will be
randomized to one of four treatment groups and neither
they nor the researchers will know into which group they
are assigned until the conclusion of the study.
Researchers hope to enroll a total of 24 patients -- six
in each group -- who they will follow over the course of
one year.

"Stem cell therapy as an adjuvant to traditional bypass
surgery is the next step to help determine the best way
to help very sick heart failure patients. This is the
first randomized study in the U.S. to evaluate the
combination of cell therapy with traditional surgical
revascularization and may help answer a number of key
questions," explained Dr. Patel.

"When you inject these cells in, they act like a homing
beacon to the heart," said Dr. Patel. "The heart's just
sending out an SOS signal saying 'Here! Come help me,' "
he said. The adult stem cells then enlist other cells
that deliver building blocks needed to partially restore
heart function.

"Standard surgical and catheter-based treatments are
reasonably effective for treating chest pain, reducing
the risk of heart attack and improving heart function.
But none has the ability to actually restore or repair
damaged heart tissue. The aim of stem cell therapy is to
repopulate the ailing heart muscle with cells that may
help restore blood supply and help the heart regain its
ability to contract more effectively and efficiently,"
added Joon S. Lee, M.D., clinical director of UPMC's
Cardiovascular Institute and assistant professor of
medicine and associate chief, division of cardiology,
University of Pittsburgh School of Medicine.

Various studies that have been conducted around the
world, including a limited number performed in the United
States, have suggested that when patients with heart
failure receive stem cells taken from their bone marrow,
their hearts show signs of improved function and
recovery. However, most of these clinical studies did not
control for variables that may have influenced patients'
clinical improvements, and all but a very few were
designed as a randomized and double-blinded trial, the
most rigorous method for evaluating clinical
interventions.

UPMC researchers expect to ask about 75 patients to
participate in the new trial in order to enroll and
randomize six patients into each of the four study
groups. A person not involved in the study will select a
card from 24 numbered one through four to determine which
group a patient is to be assigned. Then, with the patient
under anesthesia, Dr. Patel's team will harvest bone
marrow from the patient's hipbone. While the bypass
operation is taking place, the patient's stem cells will
be isolated from the bone marrow and prepared
accordingly, depending on the patient's random
assignment. Patients may be randomly selected to one of
three groups that will receive varying concentrations of
stem cells or to a fourth group receiving their own blood
serum void of stem cells.

Though researchers have speculated that human embryonic
stem cells might someday be used to regenerate either the
heart muscle or the arteries feeding the heart muscle,
the bone marrow stem cells being used in the UPMC studies
likely would not work that way, Patel said. Rather, the
stem cells may help the heart by fusing with injured
cells and helping them function better. Another, even
more likely mechanism -- but harder to prove -- is that
the injected stem cells secrete growth factors or other
substances that harness and redirect the body's healing
powers.

Dallas-born Patel's interest in Stem Cell research stems
from having seen "so many cardiac patients that we
couldn't help with surgery or with traditional
medications." Patel, 33, earned his undergraduate degree
(B.S. 1993) and graduate (M.S. 1994) from Youngstown
State University and then went on to earn his M.D. (1998)
with distinction from Case Western Reserve University. He
received additional training at Baylor University Medical
Center and University of Pittsburgh Medical Center. Among
the many awards Patel has received, is the Most
Distinguished Resident Award from the American
Association of Physicians of Indian Origin (AAPI) at the
21st Annual Convention, Orlando, FL.

francisassisi@hotmail.com

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