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Wednesday, 14 November 2007

A Stem-Cell Prospect for Ailing Hearts





Wednesday, Nov. 14, 2007

By MATTHEW KALMAN/Jerusalem

Valentin Fulga dropped out of medicine twice to pursue more-challenging research, but now it looks as though his change of heart could result in saving the lives of thousands--perhaps millions--of cardiac patients. Dr. Fulga, 47, is the scientific brain behind a new treatment for heart disease that is exciting the medical world even though it has yet to undergo full clinical testing.

More than 60 people in need of heart transplants or major surgery have been treated using the new procedure. That's a small number, but the results are nonetheless stunning: all of them improved. That's why TheraVitae, the privately owned company set up by Fulga and his Thailand-based partner Robert Clark, is being hailed as a potential giant.

Fulga's treatment repairs damaged or inactive heart tissue using adult stem cells harvested from the patient's blood and processed outside the body by mimicking the body's environment. Unlike other stem-cell therapies, which make use of bone marrow or--more controversially in the U.S.--the blood of human embryos, Fulga believes the procedure patented by TheraVitae is simpler, safer and less invasive. "The patient is effectively treating himself with his own blood, so there is very little danger of rejection," says Fulga, an ophthalmologist. "It's the safest kind of stem cell you can get."

The procedure takes about a week, including the time needed to fly the blood to TheraVitae's laboratories in Israel. There, a small number of natural cells are exposed to conditions that normally occur inside the human body. The process causes the stem cells to multiply and differentiate into cells that restore damaged heart tissue. The final product, called VesCell, is then injected into the patient's heart, where it appears to trigger the body's natural healing mechanisms, helping the heart tissue recover some of its function.

"We don't actually know the basis of the science," Fulga cheerfully admits, but his research team knows it is on to something. Soon it plans to reveal other discoveries made during its research that Fulga believes will open the way for the use of stem-cell therapy in more areas.

The company treats patients in Bangkok, where medical standards are top-notch and interest in high-tech treatment and medical tourism is booming. The process costs about $30,000 per patient, plus physician's and travel expenses, but Fulga hopes the figure can be reduced to less than $10,000.

And it's good business. Fulga and his colleagues are tapping into the estimated $54 billion--a-year market of cardiac patients in need of treatment. The company projects that it will break even soon. "We want to be the Intel of cell therapy," says Fulga.

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