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Clinical trials test power of stem cells to help damaged hearts recover

Just in time

Michael Johnson would have been shocked to learn last summer that his heart would fail by fall.

Michael Johnson hopes that participating in an innovative clinical study—along with exercising and eating right—will help him continue to recover after his heart attack. [Photo by Scott Streble]

A seemingly healthy 66-year-old businessman, Johnson had been a patient in the hospital only once: at birth. Then came September 6, 2010, when he suffered a massive heart attack. An emergency angioplasty and stent procedure opened the blockage that caused his heart attack, but only 35 percent of his heart function remained.

“They told me if I wouldn’t have come into the hospital, I would have been dead by the next morning,” Johnson recalls. “I was in disbelief that my heart could suffer so much damage.”

While recovering at Fairview Southdale Hospital and facing a future limited by significant heart failure, Johnson got another surprise: University of Minnesota researchers asked him to participate in an innovative cell therapy study that might improve his prognosis. If he agreed, he would be randomly assigned to receive either an injection of stem cells derived from his own bone marrow into his heart or a placebo injection as part of a double-blind clinical trial. Johnson signed up, and 10 days after his heart attack, he received his injection.

The study in which Johnson is participating, known as Late TIME (Transplantation in Myocardial Infarction Evaluation), is designed to evaluate the safety and effec- tiveness of infusing stem cells into a patient’s heart two to three weeks after a heart attack. Another similar study, known simply as TIME, evaluates the success of this therapy three to seven days after the patient’s heart attack. Both are funded by the National Institutes of Health.

Since the two multicenter trials began last year, more than 200 people have enrolled nationwide. Ten of them are at the University.

“The University of Minnesota has a long-standing tradition in both transplantation and cell therapy initiatives,” explains Daniel Garry, M.D., Ph.D., chief of the Medical School’s Division of Cardiology and executive director of the Lillehei Heart Institute. “Our goal with these studies is to look critically at the benefits of using a patient’s own cell therapy following a heart attack.”

Ganesh Raveendran, M.D., holds hope that cell therapy can help improve patients’ heart function after significant damage.

Led by interventional cardiologist Ganesh Raveendran, M.D., the cardiac cell therapy research team includes Garry, cardiologist Cindy Martin, M.D., and cardiothoracic surgeon Ranjit John, M.D.

“There is no doubt that in recent decades we have continued to significantly improve treatments for patients who have had heart attacks. Despite this, their heart function doesn’t recover as well as it should,” says Raveendran. “Ultimately, we hope that cell therapy will improve health outcomes and quality of life for these patients.”

In addition to helping to boost heart function after heart attacks, stem cell therapy may also increase the effectiveness of treatments for heart failure.

The U.S. Food and Drug Administration has recently authorized the team to conduct another study, in which patients in severe heart failure receive injections of their own stem cells during the implantation of a left ventricular assist device (LVAD), a device that pumps blood for a heart that is too weak to do so on its own. (An LVAD can allow the heart to rest for a time, or it can serve as a “bridge” therapy until a patient receives a transplant.)

“The holy grail of end-stage heart failure remains myocardial recovery, so our hope is that this therapy will help the heart recover better,” says John, who directs the University’s Ventricular Assist Device Program. “After a period of three to six months, we will gradually wean down the support given by the LVAD—then determine whether the function of the native heart is improving.”

Johnson believes the injection he received is helping. Nine months after signing on to participate in the study, his heart function has improved to 58 percent—just 2 percent below what is considered normal.

And after recently climbing a staircase with a load of briefcases, he noticed his heart pumping—and felt stronger.

“I think it has definitely helped me,” Johnson says of the study. “I feel like I’ve done something really proactive—in addition to exercise and eating better—that gives me the extra edge I need to have the best possible outcome.”

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