Dr. Aidan R. Raney performs a checkup on heart attack patient Mark Athens, 52, on Tuesday, Dec. 17, at Scripps Green Hospital in La Jolla. Athens received a stem cell treatment to help his heart recover as part of a clinical trial to determine the treatments safety and effectiveness.
A new stem cell treatment may help heart attack patients do something once thought medically impossible regenerate dead heart muscle.
Scripps Health in La Jolla is one of three centers testing the therapy from Capricor, a Los Angeles biotech company. The cardiac stem cells are meant to boost the hearts natural ability to perform minor repairs. If it works, scars should shrink and functional heart muscle should grow.
Capricor gets the cells from donor hearts, grows them into the amount needed for treatment, then sends them to doctors taking part in what is called the Allstar trial. Doctors inject the cells into the coronary artery, where they are expected to migrate to the heart and encourage muscle regrowth.
The trial has successfully completed Phase 1, which mainly evaluates safety. On Dec. 17, Capricor said it had received permission to begin Phase 2, which will examine efficacy in about 300 patients who will get the treatment or a placebo. More information can be found at clinicaltrials.gov under the identifier NCT01458405.
The Allstar trial is funded with a $19.7 million disease team grant from the California Institute for Regenerative Medicine, or CIRM, the states stem cell agency.
This is a highly significant announcement for us at CIRM as its the first time weve funded a therapy into a Phase 2 clinical trial, Chairman Jonathan Thomas said in a Dec. 23 statement.
About 600,000 Americans die of heart disease annually, making it the leading cause of death, according to the Centers for Disease Control and Prevention in Atlanta. Even those surviving may be left permanently impaired, if the heart is severely damaged. These are the patients Capricor seeks to help.
Mark Athens received Capricors treatment on Sept. 25, about a month after having a moderate heart attack. The Encinitas resident was the last treated under Phase 1, said Scripps cardiologist Richard Schatz, who performed the procedure. It will take about six months to know whether the treatment worked, Schatz said.
Unlike many trials, Phase 1 was not placebo-controlled, so Athens knows he got the therapy. He appeared cheerful, smiling and bantering with his examining doctor during a Dec. 17 checkup at Scripps Green Hospital.
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Stem cells tested to repair damaged hearts