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Mayo Clinic to Test Stem-Cell Heart Therapy
FDA gives the okay (January 17)
Mayo Clinic research into using stem cells to repair damaged heart tissue has won FDA approval for human testing in a pivotal phase III trial.
The CHART-2 study will evaluate cardiopoietic (cardiogenically instructed) stem cells designed to improve heart health in people with heart failure. The U.S. trial aims to recruit 240 patients with chronic advanced symptomatic heart failure.
Safety testing in humans, completed earlier in Europe, showed a preliminary 25% 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.
Going forward, treatments won’t focus just on easing the symptoms of heart disease, but rather on curing it, he said.
The process involves harvesting stem cells from the patient’s bone marrow in the hip, directing the cells to become cardiopoietic repair cells, and then injecting them back into the heart to do their work.
Source: Medical Xpress; January 17, 2014.