The University of Louisville (UofL) is conducting a groundbreaking Phase II clinical trial called CATO, which represents several significant firsts in heart failure treatment[1][3]:
Trial Characteristics
The CATO trial is a randomized, double-blind, placebo-controlled study that will enroll 60 patients across three centers: UofL, the University of Miami, and Texas Heart Institute[3].
The study focuses on patients with ischemic cardiomyopathy who have experienced heart attacks leading to scarring and heart failure[1].
Key Innovations
First-of-its-kind Features:
- First U.S. trial to test umbilical cord-derived stem cells for heart failure
- First trial to use intravenous (IV) delivery for heart failure cell therapy
- First trial worldwide to test multiple doses of stem cell therapy for chronic heart failure[3]
Treatment Protocol
Participants will receive four IV injections approximately two months apart in an outpatient clinic, with patients randomly assigned to one of three groups[4]:
- Four cell treatments
- One cell treatment with three placebo treatments
- Four placebo treatments
Scientific Details
The therapy uses mesenchymal stem cells (UC-MSCs) derived from donated umbilical cords[3]. Each umbilical cord can yield approximately 4-5 billion MSCs, providing 40-50 doses of 100 million cells each[3].
These cells have shown promise due to their anti-inflammatory properties and have been previously tested in various conditions[3].
Research Team
The study is led by Dr. Roberto Bolli, UofL professor of medicine and director of the UofL Institute of Molecular Cardiology, in collaboration with researchers from[1]:
- University of Miami Miller School of Medicine
- Interdisciplinary Stem Cell Institute
- Texas Heart Institute
- Johns Hopkins Hospital
Significance
This innovative approach could potentially transform heart failure treatment, which currently affects more than 6 million Americans and accounts for 1 in every 5 deaths[3]. The trial is funded by an $8 million grant from the Department of Defense[1].
Citations: [1] https://www.texasheart.org/dr-emerson-perin-participates-in-uofl-clinical-trial-for-new-therapy-for-heart-failure/ [2] https://news.louisville.edu/news/cardiac-stem-cells-safe-and-effective-heart-failure-treatment-report-uofl-research-team [3] https://louisville.edu/news/uofl-cardiologist-leading-clinical-trial-high-potential-new-therapy-heart-failure [4] https://cells4life.com/2024/08/umbilical-cord-stem-cells-trialled-for-heart-failure-treatment/ [5] https://www.yahoo.com/news/research-study-uofl-first-us-231809297.html