The Mayo Clinic in Rochester announced Friday that a decade-long research project on using stem cells to repair damaged heart tissue has won federal approval for human testing, a step that could have implications for millions of Americans with heart disease.

The U.S. Food and Drug Administration has approved a multistate clinical trial of 240 patients with chronic advanced symptomatic heart failure to determine if the procedure produces a significant improvement in heart function.

Safety testing in humans, completed earlier in Europe, showed a preliminary 25 percent improvement in cardiac outflow, according to Dr. Andre Terzic, director of the Mayo Clinic's Center for Regenerative Medicine.

The procedure could be a "paradigm shift" in the treatment of heart disease, Terzic said.

Treatments going forward won't just focus on easing the symptoms of the disease, Terzic said, but rather, on curing it.

The process, developed in collaborations with Cardio3 BioSciences of Belgium, involves harvesting stem cells from a heart patient's bone marrow in the hip, directing the cells to become "cardiopoietic" repair cells, then injecting them back into the heart to do their work.

Mayo researcher Dr. Atta Behfar and other members of Terzic's team isolated hundreds of proteins involved in the transcription process that takes place when stem cells are converted to heart cells. They identified eight proteins that were crucial in the development of heart cells and used them to convert stem cells into heart cells.

"This is unique in the world," Terzic said.

Forty hospitals in Europe and Israel are enrolling heart patients in human trials to test Mayo's new treatment regimen for heart failure. Enrollments are expected to be completed by the end of the year, and early results should be available in 2015, according to Dr. Christian Homsy, CEO of Cardio3 BioSciences.

If things go well, patients could start being treated with the new technology by the end of 2016 in Europe, and perhaps a year later in the United States.

Read more:
Mayo wins FDA approval to test stem-cell technique for heart patients

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