A Phase 1 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 in Louisville, Ky.
For the first time, patients with advanced heart disease already undergoing bypass surgery will be recruited for participation in the clinical trial, which uses adult stem cells taken from the patient's cardiac tissue. During surgery, a small piece of tissue that is routinely removed during the bypass procedure will be frozen and sent to colleagues at Harvard University in Boston, so that the adult cardiac stem cells can be extracted and removed.
After a three- to four-month recovery, cells will be directly injected into the patient’s cardiac scar tissue via a catheter.
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's chair in cardiology.
All patients enrolling 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. The investigators said they hope to enroll 20 patients in the phase-one trial.