Stem Cell Mediated Cardiac Repair Trial in Patients with Heart Failure Opens at Summa
A multicenter clinical trial designed to bring novel therapies to patients with advanced systolic heart failure has opened at Summa Health System. The Summa Cardiovascular Institute is one of only a few national sites, and the only one in Ohio, enrolling in this trial. The principal investigator is Kevin Silver, M.D., Director of the Coronary Care Unit at Akron City Hospital.
This Phase II study will test the ability of JVS-100, a genetically engineered DNA plasmid developed by Juventas Therapeutics, to recruit endothelial progenitor cells directly to the heart. These cells will then stimulate the new growth of cardiac myocytes and hopefully improve heart muscle function. If this strategy is successful, it would obviate the need for stem cell transplants. JVS-100 is injected directly into the heart, specifically into the coronary sinus, via a simple right heart catheterization. Here it attracts the patient’s own stem cells to the area of scar (from prior heart attacks) and promotes tissue repair.
Patients are eligible to participate in the study if they have systolic heart failure and have Class III or IV heart failure. The trial is designed to demonstrate an increase in the ability of patients to walk for six minutes, a decrease in heart failure symptoms, and an improvement in quality of life relative to placebo. Patients will be followed for at least one year after the injection. If you have any patients that you would like to refer to the trial, or have any questions about the trial, please contact Dr. Silver at 330-376-7000.
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