Stem cells repair damaged heart

ScrippsA 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 heart’s 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.

heart

Dr. Aidan R. Raney performs a checkup on heart attack patient Mark Athens, 52, 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 treatment’s safety and effectiveness. Bradley J. Fikes.

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 state’s stem cell agency.
«This is a highly significant announcement for us at CIRM as it’s the first time we’ve 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 Capricor’s 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.
There’s good reason to be optimistic about the treatment, Schatz said, because an earlier Capricor trial with a slightly different approach showed evidence of working.
Positive signs
«All their previous work showed that the scar got smaller and the muscle tissue around it got more robust,» Schatz said. «So two things happened: The viable tissue got bigger and the scar got smaller. And that should translate into some sort of clinical benefit down the road.»
That study used so-called autologous cells, taken from the treated patient. However, using donor cells is preferred over autologous for practical reasons, Schatz said. Donor cells, called allogeneic, can be banked in advance and used when needed, Schatz said, «just like a blood transfusion.» They’re also less expensive because of economies of scale.
Schatz said the first study was important as a proof of concept because it dispelled the long-held belief that heart muscle can’t be regenerated.
The source: http://www.utsandiego.com

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