By Tim Bonfield
The Cincinnati Enquirer

A Tristate man on Thursday joined a handful of patients worldwide who have received muscle cell transplants in hopes of repairing their damaged hearts.

Charles Emmerick, 71, of Middletown, was the first of up to 10 patients nationwide to get millions of leg muscle cells injected into their scarred hearts in an effort to improve the organ's beating power.

If successful, experts say this closely watched technology could lead to longer life for hundreds of thousands of Americans who suffer from heart failure but rarely qualify for hard-to-get heart transplants.

"The implications of this process and study are immense," said Dr. Dean Kereiakes, medical director of the Lindner Center for Research and Education and principal investigator of the study.

About 4.6 million Americans have heart failure, with about 550,000 new cases diagnosed each year, according to the American Heart Association. About 2,500 a year get heart transplants, while the rest rely on an array of medications and devices that help maintain heart function.

If the muscle cell transplants work, many people with heart failure could benefit from a treatment that would be cheaper than a heart transplant, would have far shorter waiting lists and would not require living on anti-rejection drugs.

"This is extremely exciting technology. But it's also a very early study. Phase 1 trials are done primarily just to see if the treatment is safe. It will require more study to see how well it works," said Dr. J. Michael Smith, a surgeon with Cardiovascular & Thoracic Surgeons Inc. "If this reaches Phase 2, we will be very interested in participating."

The muscle cell transplants being studied through the Lindner Center use a process developed by Massachusetts-based Diacrin Inc. The method is one of several possible approaches to cardiac cell transplantation.

The transplant performed Thursday actually was the end stage of a five-week process.

Emmerick qualified for the study because a prior heart attack had caused significant scarring in one area of his heart. The damage was severe enough that his ejection fraction - a key measure of heart pumping power - was below 30 percent.

He learned about the study from doctors who were preparing him for a second bypass operation, intended to route as much blood as possible to the still-functioning parts of his heart.

Once he was enrolled, doctors removed a golf-ball sized chunk of muscle from one of his thighs. That tissue was sent to Diacrin, where the cells were grown in a lab dish for about three weeks - until the researchers were confident they had at least 300 million cells to inject. After another two weeks of purification and processing, the cells were sent back to Cincinnati.

At Christ Hospital, surgeons Donald Mitts and Thomas Ivey performed open heart surgery to complete the second bypass. During that procedure, the doctors made about 30 injections to insert the healthy muscle cells into a scarred region at the bottom of Emmerick's heart.

If successful, the leg muscle cells will graft themselves into the heart tissue and begin contracting - adding to the heart's pumping power, improving Emmerick's ability to exercise without shortness of breath and potentially extending his life.

Ivey, who has performed numerous heart transplants, said, "This is one of the most exciting things I've been able to participate in during my entire career."

Emmerick and others will be monitored for two years. No one knows how long the transplanted cells will function, nor precisely how many cells are needed to produce a benefit, or what side effects might occur. The biggest concern: The new muscle cells might trigger an irregular heartbeat, which might require a defibrillator to correct.

The technology is so new that researchers also aren't sure what kind of cell transplant will work best.

Besides using leg-muscle cells, other early studies involve using stem cells from bone marrow, which could transform into actual heart muscle cells and might function better than the leg-muscle cells.

Some researchers also say fetal stem cells - which can transform into any kind of cell - could be used to repair hearts. But fetal stem cell transplants face a potential rejection risk and remain the topic of intense ethical debate. No such studies are active in humans in the United States.

Dr. Eugene Chung, director of the heart failure program at the Ohio Heart Health Center, said many cardiologists have high hopes for cardiac cell transplantation.

"This really is the next generation of heart failure therapy. The first generation was medications. The second was devices," Chung said. "The gold standard is still heart transplantation, but clearly, heart transplantation has hit its peak. We're all looking forward to alternatives."

E-mail tbonfield@enquirer.com