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 Japanese researchers harvested tissue from patients' thigh muscles
to grow sheets of cells that were then affixed to patients' hearts
during surgery.
The main point of the study was to evaluate the safety and
feasibility of the procedure. But the research team also found that
a year after the surgery, some patients had improvements in their
exercise capacity and heart function.
The results must now be confirmed with more research and larger
studies, Dr. Yoshiki Sawa of Osaka University Graduate School of
Medicine and colleagues write in the Journal of the American Heart
Association.
Nearly 6 million people in the United States have heart failure,
according to the Centers for Disease Control and Prevention (CDC).
The condition occurs when the heart can't pump enough blood to the
body.
Treatment for heart failure ranges from a combination of diet
changes, medications and physical activity to surgery. In the 27
patients in this new study, traditional treatments for heart failure
hadn't worked.
The patients had class II or III heart failure, which typically
means everyday activities left them tired, with heart palpitations
and shortness of breath.
Researchers extracted cells from a small piece of muscle taken from
each patient's thigh. They grew these cells in culture, testing for
signaling molecules that indicate the likely presence of skeletal
muscle stem cells in the mix. Then they grew the cultured cells into
small, thin sheets.
After surgery to apply the patch, patients were watched at the
hospital for complications and discharged about 50 to 60 days later.
None of them showed complications related to the surgery.
The researchers note that in previous studies, when stem cells were
injected into the heart - rather than applied as a patch - some
patients developed dangerous heart rhythms. In the new study, three
patients had irregular heart rhythms after the cell sheets were
implanted, but those rhythms were not life threatening and were
present before their surgeries.
A year after surgery, 96 percent of patients were alive. About 84
percent were alive three years after surgery.
People with heart failure caused by an enlarged or weakened chamber
of the heart - known as dilated cardiomyopathy - did not seem to
improve as much after the surgery as people whose condition was
caused narrowed blood vessels - known as ischemic cardiomyopathy.
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On average, people with ischemic cardiomyopathy improved from class
III heart failure before the surgery to class II a year later.
Additionally, during tests to see how far patients could walk in six
minutes, the group with ischemic cardiomyopathy went from an average
of 416 meters before the procedure to an average of 484 meters one
year later .
They also improved on a number of other measures, including a blood
test that shows how well the heart is working.
The researchers did not compare the patches to other treatments such
as surgery to bypass a poorly functioning blood vessel.
Dr. Eiran Gorodeski, a cardiologist at the Cleveland Clinic and a
expert on heart failure, pointed out that all the patients were
taking medications for their heart failure.
"They are being treated with other things," he told Reuters Health.
"It’s hard to know without a control group if the cells are why
these patients got better."
Larger clinical trials that include a control or comparison group
need to be performed, said Gorodeski, who wasn't involved in the new
study.
"I’m willing to buy in that this approach is feasible and safe," he
said.
Gorodeski says if the sheets of cells work, it may be due to their
hormones sending signals to the heart to repair itself.
He noted that stem cell therapy for heart failure is not approved by
the Food and Drug Administration.
"For now, treatment with stem cells remain firmly in the
experimental realm," said Gorodeski. "There are intriguing and early
signals that they may work, but we don’t have a slam dunk yet."
SOURCE: http://bit.ly/1EZ8ITx Journal of the American Heart
Association, online April 5, 2017
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