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New Studies Indicate Stem Cells Assist Heart Failure Patients

The findings were also published online in the Journal of the American Medical Association.

Another presentation at the meeting discussed a Phase II study sponsored by Mesoblast Ltd. (MSB), which found that patients with heart failure can reduce future occurrences by as much as 80 percent using an experimental stem cell treatment developed by MSB. The experimental drug, Revascor, is derived from mesenchymal stem cells taken from another person.

The trial involved patients between the ages of 20 and 80 who were tracked for at least 12 months. It included 45 patients with a history of moderate to severe congestive heart failure who were given a shot of Revascor along with standard medicines and a negative control group of 15 who did not receive Revascor. The results indicated the therapy was safe and well-tolerated at all doses, and that the overall risk of a major adverse cardiac event was cut by 78 percent.

During the follow-up period of 22 months, one patient in the group receiving Revascor died, while three fatalities were recorded in the control group.

Also shared during the AHA meeting were the results of a study in which patients who suffered from heart failure due to a heart attack showed an average of 12 percent improvement in heart function one year after they underwent an investigative treatment that involved infusing them with their own stem cells.

This Phase I clinical trial is called "SCIPIO" — an acronym for "Cardiac Stem Cells in Patients with Ischemic CardiOmyopathy." It involved 16 patients who had received diagnoses of heart failure after a heart attack and who had a left ventricular ejection fraction (LVEF) of 40 percent or lower. The normal LVEF is 50 percent or higher.

SCIPIO took place at the University of Louisville, with Dr. Roberto Bolli as lead investigator, and at the lab of Piero Anversa at Brigham and Women's Hospital/Harvard Medical School in Boston. Anversa developed the technology to grow new cardiac stem cells from a patient's existing ones.

Investigators harvested c-kit positive cardiac stem cells from each subject during coronary bypass surgery, which were then purified in Anversa's lab in Boston and allowed to grow. Once an adequate number of stem cells were produced - about 1 million - Bolli's team in Louisville reintroduced them into the region of the patient's heart that had been scarred by the heart attack.

Besides better-than-expected heart function (pre-trial projections were for a 4 percent improvement), the research team also found that the size of the scarred areas had decreased — a result that seemingly begins to disprove the long-held belief that once scarring occurs, the heart tissue is forever dead.

The results are the first report from a trial that involved administering a human subject's own cardiac stem cells; previous studies have used stem cells harvested from bone marrow. The researchers stressed that they are preliminary and larger-scale studies must be conducted before the therapy can be used widely.

The study, which was supported by the National Heart, Lung and Blood Institute, was also published November 14 in The Lancet.

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