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Stem Cells Repair Heart Muscle in Clinical Trial

Eduardo Marbán (Cedars-Sinai Heart Institute)

Eduardo Marbán (Cedars-Sinai Heart Institute)

A clinical trial at Cedars-Sinai Heart Institute in Los Angeles and Johns Hopkins Medical Center in Baltimore has shown that treating patients with their own heart-derived stem cells helps re-grow healthy muscle damaged by a heart attack. The team led by Raj Makkar of Cedars-Sinai using technology developed by Eduardo Marbán (pictured right), director of Cedars-Sinai Heart Institute and formerly of Johns Hopkins, describe their research online in the journal The Lancet (paid subscription required).

The trial is a phase 1 study that aims to test the safety of the procedure, as well as report any clinical benefits. The procedure involves taking a small piece of cardiac tissue from the patient with a minimally-invasive biopsy and growing stem cells in a lab, a process takes about four weeks and yields some 10 to 25 million stem cells.

Patients undergo extensive scanning to pinpoint the exact location of damage to their heart muscles. The lab-cultured cells are then injected back into the patient’s heart, again using a minimally-invasive procedure. Because the original cells come from the patient’s own body, no foreign immune rejections were anticipated.

The trial enrolled 25 patients who had suffered heart attacks in the previous two to four weeks. Of the 25 patients, 17 received the test procedure, while the remaining eight patients received the standard care for heart attack. The findings show that after one year, scar size was reduced from 24 percent to 12 percent of the heart in patients treated with the stem cells, an average decline in size of about half.  Patients in the control group, who did not receive stem cells, did not experience a reduction in their heart attack scars.

In the stem-cell group, no complications were reported within 24 hours of receiving the cells. After six months, no patients had died, developed cardiac tumors, or experienced a major adverse cardiac event — heart failure or another heart attack — in either group. After 12 months, however, four patients in the stem-cell group had serious adverse events compared to one patient in the control group.

Marbán developed the stem-cell growth process while on the Johns Hopkins faculty. Johns Hopkins University has filed a patent on the process and licensed the technology for commercialization to Capricor Inc. in Los Angeles, a biotechnology company founded by Marbán. The research was funded by U.S. National Heart, Lung and Blood Institute and Cedars-Sinai; no funds from Capricor were involved in the trial.

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