First-in-the-World Study Looks to Repair Heart Damage

Ischemic heart failure from previous heart attacks and coronary artery disease is the leading cause of death in the world, affecting more than 12 percent of the world’s population, according to the World Health Organization. Stem cell therapy has been conducted to try to repair heart damage from ischemic heart failure, but in previous studies, the two types of stem cells (autologous bone marrow derived mesenchymal cells [MSCs] and endomyocardial biopsy derived c-kit+ Cardiac Stem Cells [CSCs]) have been used in separate trials. In a first-in-the-world study, the Minneapolis Heart Institute Foundation (MHIF) is about to begin the CONCERT study, led by Principal Investigator Jay Traverse, M.D. The study will use MSC’s and CSC’s together to learn if the combination would be more successful than using either alone based on pre-clinical studies in swine demonstrating an enhanced synergistic effect of the combination.
 
This study is sponsored by the National Institutes of Health and the Cardiovascular Cell Therapy Research Network (CCTRN), of which MHIF is a charter member. The focus of the study is to assess the relative safety of CSCs and MSCs, delivered alone or in combination, when compared to placebo. Researchers will analyze any change or improvement in left ventricular (LV) function by cardiac MRI as well as clinical outcomes and quality of life.
 
The study is a phase II, randomized, blinded, placebo-controlled study of 160 subjects at the seven CCTRN sites throughout the United States. All recruited subjects will have an ischemic cardiomyopathy with an ejection fraction of less than 35 percent and must have a significant amount of scar tissue as measured by the MRI (greater than 5 percent). The first 16 patients were recently enrolled in a U.S. Food and Drug Administration-required safety run-in phase with the remaining patients to be enrolled in the fall after a three-month safety analysis is performed. This will be the first cardiac stem cell trial to perform magnetic resonance imaging on patients with defibrillators and pacemakers
 
“This combination of cells represents the most potent cell therapy product ever delivered to patients,” said Traverse. “Confirming that both types of stem cells together work better than either individual cell type could lead to improved patient outcomes and better quality of life for ischemic heart failure patients.”
 
The Minneapolis Heart Institute Foundation (MHIF) is dedicated to improving the cardiovascular health of individuals and communities through innovative research and education. MHIF is a recognized research leader in the broadest range of cardiovascular medicine and population health initiatives. Each year MHIF leads more than 175 active research projects and publishes more than 120 peer-reviewed studies. Cardiologists, hospitals and communities around the world adopt MHIF protocols to save lives, improve care and create healthier living opportunities.
 
MHIF provides more than 10,000 hours of education each year putting its research into practice to improve outcomes. And, MHIF leads population health research to connect, engage, inform and empower individuals and communities to improve their health. The Minneapolis Heart Institute Foundation’s work is funded by donors and sponsors and supports research initiatives of Minneapolis Heart Institute at Abbott Northwestern Hospital.