In a groundbreaking development, researchers at the University of Louisville and UofL Health are pioneering a novel stem cell therapy that could transform the landscape of heart failure treatment. This innovative approach, utilizing umbilical cord-derived stem cells, marks several firsts in the field of cardiology and offers new hope for millions of Americans suffering from this debilitating condition.
The CATO trial, led by Roberto Bolli, a Distinguished Professor of Medicine and Director of the UofL Institute of Molecular Cardiology, will follow 60 participants over the course of one year to evaluate their heart condition, exercise tolerance, quality of life, heart size, and scarring through MRI and blood tests. These participants will be selected from three different centers, including UofL, the University of Miami, and Texas Heart Institute. In an outpatient clinic, they will receive four IV injections that are about two months apart, along with being randomized to receive four cell treatments.
The trial focuses on patients with ischemic cardiomyopathy. Funded by an $8 million grant from the Department of Defense, this four-year, multicenter study aims to determine whether single or multiple doses of stem cells can improve the health and quality of life for heart failure patients.
What sets this therapy apart is its use of mesenchymal stem cells (UC-MSCs) derived from donated umbilical cords. These adult stem cells, known for their anti-inflammatory properties, have been tested in various conditions but never before in heart disease in the U.S. The cells are processed at the University of Miami's Interdisciplinary Stem Cell Institute, with each cord yielding 40-50 doses.
Perhaps the most exciting aspect of this new therapy is its potential for widespread accessibility. Unlike traditional stem cell treatments that require invasive procedures, these cells are administered through a simple IV line. This not only reduces costs, but also makes the treatment more accessible to patients in underserved areas. Furthermore, the cells can be manufactured and stored frozen that makes them ready for use when needed. This is a significant advantage over personalized cell therapies.
This is the first U.S. trial to test umbilical cord-derived stem cells for heart failure and the first to employ intravenous delivery of cell therapy for this condition. Moreover, it's the world's first trial to explore multiple doses of stem cell therapy for chronic heart failure.
Reference:
Coffman B. UofL cardiologist leading clinical trial for high potential new therapy for heart failure: UofL News. UofLNews. August 6, 2024. Accessed August 23, 2024. https://www.uoflnews.com/post/uofltoday/uofl-cardiologist-leading-clinical-trial-for-high-potential-new-therapy-for-heart-failure/.