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Stem Cell News
U.S. Researchers Still Question Stem Cell Therapy,
But Can't Deny Effectiveness
By Jennifer Booth Reed, News-Press, May 20, 2007
Some U.S. researchers warn that much remains
unknown, still, local patients are going overseas to
put their hopes and spend their money on stem cell
treatment.
Currently, adult stem cells are being used in
numerous clinical trials worldwide to establish their
effectiveness in treating patients with cardiovascular
diseases. 67 trials are acknowledged by the National
Heart, Lung, and Blood Institute for investigating how
to regenerate damaged heart tissue. But a
biotechnology firm is saying that they have already
accomplished just that.
The company TheraVitae operates in Thailand and
Israel, with pre and post treatment care performed by
Dr. Zannos Grekos, a Bonita Springs cardiologist.
Stem cell researchers said that before putting
their confidence in procedures like the ones Southwest
Floridians are seeking, they want to discern much more
about stem cells. The cardiovascular experts contacted
for this report did not want to discuss TheraVitae
directly.
"There are little niches here and there doing
various types of treatments without much
science," said Dr. Carl Pepine at the University
of Florida. UF is part of the Cardiovascular Cell
Therapy Research, a five-member consortium conducting
research with the backing of the National Heart, Lung
and Blood Institute.
Treating those diagnosed with heart failure and
those who have had heart attacks using stem cells is
the focus of Pepine's research.
"Nobody knows what the proper dose is,"
Pepine said. "How many cells should you
give?"
How soon a patient should receive cells following a
heart attack will also be investigated by Pepine's
study.
Sonia Skarlatos says that researchers are trying to
determine which variety of stem cell is really
responsible for tissue regeneration. Sonia is the
acting director for the division of cardiovascular
diseases at the National Heart, Lung and Blood
Institute.
"We are still not sure what is the right cell,
what is the right delivery and what is the right
dose," Skarlatos said.
Skarlatos says that it is tough to draw conclusions
from the small-scale studies that have been conducted
all over the world. Various doses of cells and
different types have been used on patients who all
have varying degrees of heart functionality.
"It makes it very hard to compare all the
trials," Skarlatos said.
But the one thing that Skarlatos does agree with is
that stem cell treatment is safe. And that is good
news for patients wanting to at least give the cells a
shot at healing their ailments.
Part of the explanation that patients see progress
could be due to the development of new vessels that
stem cells encourage says Dr. Johnny Huard, the
director of stem cell research at the Children's
Hospital of Pittsburgh. Huard said that too much
vascular growth could also be a problem.
Huard is also curious to find out if other parts of
the body could also be affected by stem cells injected
into the heart.
"One thing is very important: You may inject
cells in the heart, but are they migrating?" he
said.
50-year-old Neim flew to Bangkok last November for
stem cell treatment to heal his deteriorating heart.
He has gotten used to people and their questions
about the treatment.
"(My cardiologist) just kept hoping for
improvement. Finally, he broke the news. He gave me my
time — five years," Malo said.
Neim co-owns a 6,000 square foot restaurant with
his brother, and he couldn't walk around it without
stopping at least once to catch his breath. His viper
sports car was not being driven. Even tying his shoes
was impossible because he couldn’t bend down due to
his weakness. It was all because half of Neim's heart
tissue was dead.
"I felt myself going downhill. I was so tired
out," he said.
Since he would be leaving behind two daughters and
his wife, he started to make arrangements, and began
to get his finances in order.
As fortune would have it, Neim came to know of the
stem cell treatment in Bangkok from a customer at his
restaurant. Before he knew it, he had been accepted as
a patient after he did his research and sent his
medical records to Thailand.
Neim sent $34,000 in advance for the procedure by
electronic check.
"I had nothing to lose — nothing but the
money," Malo said.
Grekos, who is an acquaintance, accompanied him on
the trip.
He leans over to tie his shoe with a grin now, six
months following the procedure. Frequent breaks are a
thing of the past, and he can now manage his Watermark
Grille more effectively. His Viper doesn't get the
best gas mileage, but he'd rather be driving it around
like he does now instead of having it sitting in the
garage cold.
Before he left for Bangkok, his ejection fraction
(a measure of how forcefully blood pumps) was 26.
Normally it should be 55 to 65, and Neim has made it
all the way back to 40 so far. He says that the proof
is undeniable and in the numbers.
"I've got life again — I'm excited,"
Malo said.
It is too early to tell if he will need another
injection of cells, or if he will continue to improve
without further treatment. Those questions are still
unanswered sine the procedure is so new.
Regardless, Neim thinks he has found a new lease on
life.
"I'm just the luckiest man in the world,"
he said.
More than 2,00 cardiac patients have received stem
cells worldwide, with many procedures being performed
in Brazil or Germany. But Grekos says that Thailand is
more open to medical tourism than the other nations.
Grekos said he's confident in the procedure, but does
agree that more research is still needed. He plans to
contribute data on stem cell therapy by measuring his
patient's every three months.
"As our experience grows, our need for
knowledge grows," Grekos said.
Grekos hopes that the United States plays host to
FDA approved trials using methods that are the same as
those used in Bangkok. Some researchers feel that the
protocols are difficult to get set, but many of Grekos'
patients feel that the FDA is being lazy about this
matter. Either way, some individuals argue that before
a patient pays $40,000 for the treatment, they should
wait for the FDA clinical trials to validate the
procedure. But few have the time to wait.
"The worst thing that could happen is you
start a trial and you have a side effect, or, God
forbid, a patient dies," Huard said. "You're
not only going to slow down your work, you're going to
slow down the entire field."
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