Osiris's Adult Stem Cells Help Heart Attack Patients in Study

Osiris Therapeutics Inc.'s easy-to-administer stem cell treatment helped patients recover after a heart attack and eased their symptoms in a study.

The cells were given intravenously to patients who had a heart attack within the past 10 days, researchers said. The hearts of those who got the cells pumped 25 percent more efficiently both three months and six months after treatment, according to research presented today at a science meeting.

The study, using adult cells gathered from bone marrow, is the first to transfer stem cells from donors to heart patients. Since an IV line delivers the cells, rather than a complex heart procedure, ``they could be given at a community hospital'' rather than an academic center, said Marc Penn, director of the Bakken Heart Brain Institute at the Cleveland Clinic.

``It's very exciting, perhaps a sea-changing trial for the field,'' said Penn, who was not involved with the study and has no relationship with Osiris. Because the cells don't come from the patients themselves, they can be made in large batches ``offering the chance for an off-the-shelf product,'' he said.

Two-thirds of 53 patients in the study, reported at the American College of Cardiology meeting in New Orleans, got stem cells. The others got a look-alike solution. Patients who didn't get the cells were four times more likely to have problems with irregular heartbeats and five times more likely to have premature contractions, the research found.

Osiris, based in Baltimore, is one of dozens of companies conducting or getting ready to begin studies of adult stem cell- based products to treat diseased hearts. Most will use patients' own cells and require the use of catheters threaded from the groin to the heart to deliver the cells.

Unique Treatment

The hope is that stem cells can provide the field of cardiology something it now lacks: a unique, new treatment for the industrialized world's deadliest disease. In the U.S., 1.2 million people have a heart attack each year, more than 5 million have chronic heart failure and almost 16 million have clogged arteries, according to the American Heart Association.

While positive study results on stem cells are drawing increasing interest from researchers, it will take years of time and research before cardiologists will routinely use stem cells for heart disease, said Gregg Stone, director of cardiovascular research at Columbia University Medical Center in New York.

``It's a significant hurdle to be able to do the right kind of studies, and be able to show improvement'' in pumping efficiency and that it makes a real difference in how patients feel and function, Stone said in a March 24 interview.

Potential

Interest in the potential of adult stem cells to treat heart disease developed in the late 1990s after research showed the cells could be coaxed into forming cardiac muscle cells that actually beat in a dish, contracting rhythmically.

In subsequent studies, stem cells delivered to the damaged hearts of mice, dogs, pigs and sheep survived in the animals' hearts and appeared to reduce the amount of scar tissue.

Companies using adult cells avoid the controversy that surrounds cells from embryos. Embryonic stem cells are among the first cells created after conception and have the potential to turn into any other cell type. Scientists hope they may one day be used to repair or replace damaged material in the brain, heart and immune system to cure Alzheimer's, heart disease, diabetes and other diseases.

Because embryos are destroyed in the process of extracting the stem cells, though, many oppose the research on ethical grounds. President George W. Bush issued an executive order in 2001 barring the use of federal funds for research on all but a few embryonic cell lines.

Hidden Cells

Adult stem cells are hidden in tiny numbers in developed organs where they can grow into specific cell types as needed to replace or refurbish damaged tissue.

The Osiris study was led by Joshua Hare, chief of cardiology at the University of Miami's Miller School of Medicine. Hare does not own shares in Osiris and was not paid to conduct the trial, he said.

Before the trial, some experts were concerned that the cells, given intravenously, might migrate to the lungs and cause problems or be treated as foreign invaders, triggering an immune reaction, Hare said.

``They may not get to the heart; they may get trapped in the lungs'' were among the concerns, he said.

The treated patients, though, also did better on tests that measured their lung function, perhaps because the cells reduced inflammation and scarring in the lungs, Mills said.

``We went into this trial looking to see if we have a cardiac drug,'' Mills said. ``We confirmed that, and we also found out that we might have a drug for'' respiratory disorders like chronic asthma or emphysema.

Larger Trial

The company is now working to start a larger trial for heart attack patients, focusing on people who had serious attacks, and may also set up a separate study for patients with pulmonary problems, Mills said. Osiris is developing the heart treatment, which it calls Provacel, with Boston Scientific Corp., the Natick, Massachusetts-based maker of medical devices.

Shares of Baltimore-based Osiris rose 59 cents, or 3.4 percent, to $17.90 on March 23 in Nasdaq Stock Market composite trading. The stock has risen 63 percent in the last six months.