SUNDAY, April 20, 2003 (HealthDayNews) -- Can a vial of a heart-failure patient's blood -- zapped with heat, radiation and ozone gas, then injected back into the body -- reduce the risk of death?
The developer of an experimental treatment thinks so, and now the theory's about to be put to its first large-scale test.
It's called "immune-modulation therapy," an unconventional approach to fighting heart failure by tricking the immune system into reducing inflammation.
The therapy yielded impressive results in a pilot trial of 73 patients with advanced heart failure. During the six-month review, about half the patients received the immune-modulation therapy; the other half, placebos. All the patients also received their normal medications.
Only one patient receiving the therapy died during the course of the study, compared with seven deaths among the patients who were given placebos. And 21 patients who received placebos had to be hospitalized, compared with 12 of those who got the therapy.
Dr. James B. Young, head of the heart failure and cardiac transplant medicine section at the Cleveland Clinic, participated in the pilot and is to serve as principal investigator in a yearlong, 2,000-person study beginning this spring.
Noting that a few previous attempts to treat heart failure with anti-inflammation drugs have failed, Young says, "I entered the original pilot study pretty skeptical."
The results of the initial trial, however, convinced him immune-modulation therapy -- developed by Toronto-based Vasogen Inc. -- merited a large-scale test.
"What we saw was a highly statistically significant reduction in death rates as well as a statistically significant reduction in hospitalizations," Young says.
Nearly 5 million Americans suffer from congestive heart failure, which weakens the heart so it doesn't pump blood efficiently. About half of these patients die within five years of diagnosis.
Effective new drug treatments have been elusive in recent years, and if the coming study proves fruitful, it could represent a treatment breakthrough, Young says.
"If you look at where we are with new medications, I think we are at our limit with new drugs," Young says. "I just don't think we're going to have a lot of hits as far as new drugs are concerned. What this has led a lot of us to do is focus on alternative measures that can be combined with traditional therapies."
In immune-modulation therapy, about 10 cubic centimeters of blood are drawn from the heart-failure patient, then exposed to 108-degree heat, radiation from ultra-violet light and ozone gas. The computer-controlled process stresses the cells, causing cell death. When the blood is injected back into the body, it alters the immune system and, through a variety of signaling processes among cells, reduces inflammation, which is associated with heart failure.
In the trial beginning this spring, patients will receive immune-modulation therapy for a year -- twice weekly at first, then weekly, then monthly. As with the pilot, the therapy will be in addition to the patients' regular medications.
"The immune system is an unbelievably powerful ally if we learn to harness it and appropriately activate it when necessary and suppress it when we need to," Young says.
Still, he acknowledges the small sample size in the pilot study, and says judging success would have to await results of the larger test. /p>
Dr. Clyde Yancy, an associate professor of medicine at the University of Texas Southwestern Medical Center, says immune-modulation therapy appears to be based on "sound science" and the preliminary test yielded encouraging results.
That said, he cautions against concluding the therapy works based on the small pilot study. "We have many times before seen pilot trials not pan out in a larger study," says Yancy, a spokesman for the American Heart Association.
Yancy says inflammation, which the therapy targets, is associated with heart failure, but experts remain uncertain whether it causes the disease or is a symptom.
"We are still looking for that initial problem that occurs that sets up this whole cascade of events that is known as heart failure," Yancy says. "We need to find that single focus that identifies how this whole thing gets started."
The experimental therapy, he says, may help determine whether inflammation is the root cause of the disease.
Yancy stresses that highly effective medications already exist for all but the most severely ill heart patients. But he says many patients who could benefit from medications, including angiotensin-converting enzyme (ACE) inhibitors and beta blockers, do not take them.
More information
For more on heart failure, visit the American Heart Association or the Heart Failure Society of America.
