Spotlight
Novel Therapy for Heart Failure
| Florida Hospital Tampa
Two Tampa-area institutions are the first in the region to enroll patients in a nationwide clinical trial of a novel gene therapy to treat heart failure. The therapy could promote tissue regeneration by encouraging the body to deploy more stem cells to the injury site.
The STOP-HF trial brings together cardiovascular specialists at USF Health and the Florida Hospital Pepin Heart Institute and Dr. Kiran C. Patel Research Institute.
Dr. Charles Lambert, medical director of Florida Hospital Pepin Heart Institute, and Dr. Leslie Miller, director of the USF Heart Institute, are leading the way for the trial, which spans 10 sites across the United States and will enroll 90 patients. Locally, the trial is the first of several regenerative medicine clinical trials teaming the USF Heart Institute with Florida Hospital Pepin Heart Institute.
Heart failure happens when the muscles of the heart become weakened and cannot pump blood sufficiently throughout the body. The injury is most often caused by inadequate blood flow to the heart resulting from chronic or acute cardiovascular disease, including heart attacks. Considerable scientific evidence has emerged over the past decade demonstrating the high therapeutic potential of stem cell-based regenerative medicine for a host of diseases, including heart failure — a leading cause of death, disability and hospitalization.
The gene therapy is performed by direct injection into the heart using an investigational system in the catheterization laboratories at Florida Hospital Pepin Heart Institute.
“Stem cells have the unique ability to develop into many different cell types, and in many issues they serve as an internal repair system, dividing essentially without limit to replenish other cells,” Lambert explains. “This trial is unique in that it uses gene therapy to turn on a process leading to cell regeneration rather than simply administering stem cells directly.”
Miller, national principal investigator for the trial, calls it the beginning of a new era in cardiovascular therapies.
“Targeted gene and cell therapies delivered directly into the heart hold promise for helping to regenerate tissue, reduce injury and restore heart function,” he says. “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.”