First Human Trial Tests Stem Cell Based Treatment for Heart Attacks (3/28/2007)

Despite the enduring controversy surrounding the use of embryonic stem cells for disease research, scientists continue to evaluate therapeutic potential of other types of stem cells. Previous research on the efficacy of stem cell therapy for heart repair has shown possible benefit from mesenchymal cells (MSCs) - cells found in bone marrow that create connective tissue, bone and cartilage. A study presented Mar 25th, 2007 at the American College of Cardiology's Innovation in Intervention: i2 Summit, reveals the results of the first human trial using MSCs for the treatment of myocardial infarction (MI, or heart attack).

Innovation in Intervention: i2 Summit is an annual meeting for practicing cariovascular interventionalists sponsored by the American College of Cardiology in partnership with the Society for Cardiovascular Angiography and Interventions.

As a cell-based therapy, MSCs have a number of unique advantages: they can be taken from genetically distinct donors, are easy to prepare, and have a tendency to collect within injured areas. In animal models, MSCs not only home to regions of MI, but reduce infarct size and improve ejection fraction - the portion of blood that is pumped out of the heart as a result of a heartbeat, and a primary indicator or the heart's health.

Researchers from ten medical centers across the United States, led by Joshua Hare, M.D., of the University of Miami, Miller School of Medicine, conducted a Phase 1 trial to assess the safety and efficacy of infusing MSCs intravenously to 53 patients within ten days of a heart attack. In the trial, patients were randomized to one of three doses: 0.5, 0.6 or 5 million MSCs/kg, and each dose was compared with placebo. The occurrence of treatment-related serious adverse events was evaluated over a six-month period, and efficacy was assessed using echocardiography.

Over the six month follow-up period, the stem cell-treated patients had lower rates of side effects such as cardiac arrhythmias, and had significant improvements in heart, lung and global function. Echocardiography showed improved heart function, particularly in those with large amounts of cardiac damage.

"This trial makes an important contribution in the field of stem cell-based treatments for hear disease by providing safety and efficacy data for a unique and promising type of stem cell to treat cardiac damage," said Joshua Hare, M.D., of the University of Miami and lead author of the study. "It's important to note that this study represents a first step, and, as in other disease categories, we must perform additional, larger trials to determine the real world application of mesenchymal cell therapy to fight heart disease."

Note: This story has been adapted from a news release issued by the American College of Cardiology

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