The Pepin Heart Institute has a history of cardiovascular stem cell research as part of the NIH sponsored Cardiac Cell Therapy Research Network (CCTRN) as well as other active cell therapy trials. Locally, the STOP-HF trial is the first of several regenerative medicine clinical trials teaming the USF Heart Institute with Florida Hospital Pepin Heart Institute, which is adjacent to the USF Health campus.
"This is the beginning of a new era in cardiovascular therapies," said Dr. Leslie Miller, national principal investigator for the STOP-HF trial and professor of cardiovascualar sciences at the USF Health Morsani College of Medicine. "Targeted gene and cell therapies delivered directly into the heart hold promise for helping to regenerate tissue, reduce injury and restore heart function. USF Health, working with our partners, will find new ways to diagnose and treat patients, with the aim of reducing and ultimately harnessing the global impact of heart disease."
The trial, sponsored by Juventas Therapeutics, is a double blind, randomized, placebo-controlled Phase II study evaluating the safety and effectiveness of JVS-100 in patients with ischemic heart failure. JVS-100 is the name of the gene therapy that directs the heart muscle to produce Stromal cell-Derived Factor 1 (SDF-1), a protein that has been shown to repair damaged tissue in the body through the recruitment of circulating stem cells to the site of injury, prevention of ongoing cell death and restoration of blood flow.
Earlier this year, Juventas reported results from its Phase I study in Class III ischemic heart failure patients. In addition to meeting the primary safety endpoint, patients in the study who received the drug demonstrated clinically significant improvements in exercise levels at the 12 month mark.'/>"/>
|Contact: Anne DeLotto Baier|
University of South Florida (USF Health)