Trial to Test Stem Cells for Heart Attacks



I'm surprised they are only getting around to this now. But, thinking back, I
believe there were other tests of this technique.

Bill

_____________________


Trial to Test Stem Cells for Heart Attacks
By RANDOLPH E. SCHMID, Associated Press WriterMon Jul 25, 8:21 PM ET

A clinical trial to test the safety of treating heart attack damage with stem
cells is about to get under way, following a study that showed the therapy
helped in pigs.

Two patients have been enrolled so far at Johns Hopkins Hospital in Baltimore,
and a total of 48 are expected to take part across the country, said Dr.
Joshua M. Hare, who is leading the study.

"Anytime something new comes along there is a sense of excitement and that's
the feeling that we have. And we obviously hope it will be borne out by the
results," Hare said in a telephone interview.

The process uses adult stem cells taken from the bone marrow. These cells,
called mesenchymal cells, have been shown to give rise to a variety of cell
types. While they don't have the potential to develop into as many cell types
as embryonic stem cells, using them avoids the controversy over taking cells
from a human embryo.

In tests in pigs, stem cells taken from another pig's bone marrow were
injected into the animal's damaged heart. After just two months, the stem
cells had helped restore heart function and repaired damaged heart muscle by
50 percent to 75 percent.

Those results are reported in Tuesday's issue of Proceedings of the National
Academy of Sciences.

The work is an early indication that stem cells may have therapeutic value in
treating heart attacks, but a lot of work remains to be done, said Dr. Sidney
Smith, cardiology chief at the University of North Carolina at Chapel Hill.

It is a long way between successful work in a few pigs and a therapy that
could benefit thousands of humans, said Smith, a spokesman for the American
Heart Association. In the meantime, he said, efforts such as stopping smoking
and controlling cholesterol can help prevent many of those heart attacks.

The planned tests in humans are a Phase I trial, meaning that the goal is
merely to make sure the procedure is safe in humans. Only after safety is
established will the scientists move on to a Phase II trial to see if it works
as well in people as in pigs.

But researchers will be checking to see if the procedure is helping the
people. Hare said study participants will be watched for two years. At six
months after the treatment they will undergo an MRI scan to check their heart
function.

Hare said he hopes that will be taking place by mid-2006.

In the initial trial, he said, the cells will be infused into the blood
stream. In the Phase II trials, a variety of methods would be used to deliver
the cells, he said.

In the pig study, the researchers studied 14 animals that had had heart
attacks. Seven were given the stem-cell therapy and seven were not. The adult
stem cells were directly injected into the heart muscle through a catheter.

The seven treated pigs had their heart muscle contraction restored to levels
that existed before the heart attacks and dead scar tissue nearly disappeared
after therapy, the researchers said.

In the seven other pigs, which were injected with an inert placebo, no
recovery was observed and the animals' condition worsened, leading to the
development of congestive heart failure within two months after heart attack,
according to the researchers.

The research was funded by the Johns Hopkins University School of Medicine,
Osiris Therapeutics, The Donald W. Reynolds Foundation and the National
Institutes of Health.

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