The world’s first phase one FDA-approved clinical trial using adult cardiac stem cells to treat heart disease will be conducted by a team of University of Louisville doctors at Jewish Hospital.

For the first time, adult patients with advanced heart disease who already are undergoing bypass surgery will be recruited for participation in the clinical trial, which uses stem cells taken from the patient’s own cardiac tissue. The surgical team will freeze a small piece of cardiac tissue that routinely is removed during the bypass procedure and send it to the New York Medical Center to extract the stem cells.

After the patient has recovered for three to four months, physicians will directly inject the stem cells into cardiac scar tissue using a minimally-invasive cardiac catheterization procedure, which reaches the heart through a large artery in the patient’s leg.

The patients will be evaluated over the course of at least a year for heart function and blood flow. The heart’s overall size and the size of the scar tissue will be measured.

“Our hope is that the cardiac stem cells will help the heart tissue regenerate, reducing the size of the patient’s scar tissue and improving heart function,” said study leader Roberto Bolli, Jewish Hospital Heart and Lung Institute Distinguished Chair in Cardiology.

All patients who enroll in the clinical trial will receive the cardiac stem cell therapy, since this is a phase-one clinical trial designed to test the treatment’s safety and feasibility.

Bolli, who also is chief of the Division of Cardiology and director of UofL’s Institute for Molecular Cardiology, is collaborating with a number of leaders in the field of cardiovascular and stem cell medicine for this clinical trial. They include Piero Anversa of Harvard University and Brigham and Women’s Hospital, and Mark Slaughter, chief of the Division of Cardiothoracic Surgery at UofL.