Innovative procedure could help millions with heart disease
Nov. 16, 2001

PHOTO BY A.ENRIQUE VALENTIN / SOUTH FLORIDA SUN-SENTINEL Bioheart CEO Howard J. Leonhardt shows the equipment used to rejuvenate heart tissue.

By NANCY MCVICAR
South Florida Sun-Sentinel

With her failing heart pumping at only 20 percent of normal capacity, a 78-year-old woman in the Netherlands became the first person in the world to get a new treatment designed to rejuvenate damaged heart muscle.

Doctors working with Bioheart, Inc., a Weston, Fla., biotech company, took immature muscle cells from her thigh, cultured them in the laboratory to increase their numbers into the millions, then injected them into scar tissue in her heart.

This week at the American Heart Association annual meeting in Anaheim, Calif., the results of her case were to be presented, and the news is likely to excite experts in heart disease.

“I can’t share the data with you yet, but it’s good data,” said Harold Haimes, Bioheart’s vice president of strategic operations at the firm’s Framingham, Mass., office.

Millions of people potentially could be helped by the technique, said Dr. Barry Katzen, medical director at Miami Cardiac and Heart Institute.

“The mechanical heart (first implanted into a Kentucky man) is a great technological advance and I don’t want to diminish it, but imagine how much simpler it would be to repair the heart from within,” Katzen said.

“Many patients who have heart failure from poorly functioning ventricles could benefit from this,” Katzen said.

Haimes said Bioheart planned to file two applications with the U.S. Food and Drug Administration this week seeking to begin testing the innovative procedure on patients in this country — one using the catheter technique and one for implanting the cells during open-heart surgery. If clinical trials prove the technique effective, it could be in widespread use in three to four years.

In the procedure performed May 25 in Rotterdam, a catheter was threaded up from an artery in the patient’s groin into her heart, where a special needle injected the cells at a dozen locations in the heart’s scar tissue.

The theory, proven effective in animal testing, is that the muscle cells will take hold, mature into heart muscle and strengthen her heart’s pumping ability to at least 40 percent of normal, said Howard J. Leonhardt, co-founder and CEO of Bioheart.

Patients whose hearts are pumping at only 20 percent of normal capacity are generally expected to live no more than two years, while a person whose heart is pumping at 40 percent or more is expected to have a normal life span, he said.

Because the procedure does not require open-heart surgery, recovery is quick, and because the cells are taken from the patient’s own body, there is no danger of rejection. The first patient was released from the hospital the next day, Leonhardt said.

The cells can also be implanted during open-heart surgery done to clear blocked arteries.

Bioheart has collaborated with the Biomedical Engineering Institute at Florida International University in Miami-Dade and other scientists in culturing the cells called myoblasts — adult stem cells destined to become muscle tissue.

The company also developed the catheter and specially designed needle to inject the myoblasts.

“If this cell therapy lives up to its promise, we will look back to (the first procedure) the way we look back to the first balloon angioplasty,” said Dr. Patrick Serruys, who led the team that performed the procedure and will report the results at the heart association meeting.

“This may be one of the most significant developments in the history of treating heart disease,” said Serruys, professor of interventional cardiology at Erasmus University in the Netherlands.

Subsequent patients have received varied numbers of cell injections during the procedure, Leonhardt said, as researchers try to determine the optimum number needed to boost the heart’s pumping ability.

Dr. Phillipe Menasche performed the first injections of myoblasts into a patient’s failing heart in France in June 2000, during an open-heart surgical procedure. The 72-year-old man also had new vessels grafted to improve blood flow to the heart.

Menasche, professor of surgery at Bichat Hospital, in Paris, reported in The Lancet medical journal in late January that the patient is doing well.

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Leonhardt credits Dr. Doris Taylor, a researcher at Duke University Medical Center, who now serves on Bioheart’s board of directors and scientific board, with pioneering the work.

“She was the first to prove that muscle cells were the only kind of cells that would get the scar tissue to contract,” Leonhardt said. “Clinically, we need the scar to stretch with the heart muscle.”

Leonhardt said the researchers experimented with stem cells and found that when they were placed in scar tissue, they took on the characteristics of the scar tissue instead of turning into heart muscle. It was necessary to use cells that had already received the biological signal to become muscle tissue, he said.

Taylor said she has been working on the problem of restoring function to damaged hearts for 11 years.

“It’s really exciting to see it coming to fruition,” Taylor said. “In early animal studies, we took cells from the leg and transplanted those into injured regions of heart. We found we could get the cells to survive in the injured area, and the hearts got better. And not only did the hearts get better in their ability to relax, but also in their ability to contract, so they were beating stronger.”

The earliest work was in rabbits, then pigs, and later mice.

“We’ve been trying to improve (the technique) and make it more reproducible, and now there are enough pre-clinical data out there to go forward into (human) clinical trials,” she said.

Leonhardt was familiar with Taylor’s work and wanted to get her involved in Bioheart. The two met for the first time at an American Heart Association conference two years ago and later agreed to collaborate.

If a Phase I clinical trial is given the go-ahead by the FDA, about 30 patients would get the cell injections to make sure the technique is safe. If so, the trials would be expanded to several other locations and involve many more patients.

“It’s an exciting time to be involved in this field, and more and more people are getting involved, but we can’t let our excitement override good science,” Taylor said.

“It’s critical that we do these trials properly because this is all about patient care, and it’s all about coming up with a better treatment for heart disease,” she said. “Doing it wrong will doom the field and we’ll never realize the potential that’s out there. It’s important that we let the science drive this forward.”