January 10, 2017 — 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 MSCs and CSCs 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 magnetic resonance imaging (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 < 35 percent and must have a significant amount of scar tissue as measured by the MRI (> 5 percent). The first 16 patients were recently enrolled in a U.S. Food and Drug Administration (FDA)-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 MRIs 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.”
For more information: www.mplsheart.org