Active Clinical Trials

We are leading CATO, a multicenter clinical trial to test a new stem cell therapy using mesenchymal stem cells produced from donated umbilical cords. These adult stem cells are isolated and expanded and then delivered to heart failure patients intravenously. If successful, this would be one of the biggest advances ever in cardiovascular medicine.

This trial is the first in the U.S. to test umbilical cord-derived stem cells in patients for heart failure and the first to use intravenous (IV) delivery of cell therapy for heart failure. It is the first trial in the world to test multiple doses of stem cell therapy for chronic heart failure.

This Phase II clinical trial involves patients with ischemic cardiomyopathy, that is, those who have had a heart attack resulting in scarring and heart failure. An $8 million grant to UofL from the Department of Defense is funding the four-year, multicenter trial, which aims to determine whether one or multiple doses of stem cells improve health and quality of life for heart failure patients.

More information about this trial on clinicaltrials.gov 

To learn more about this trial, contact:

Roberto Bolli 
roberto.bolli@louisville.edu 
502-608-5426.

In collaboration with the University of Miami, we are investigating the safety and effectiveness of human allogeneic mesenchymal stem cell (hMSC) therapy for non-ischemic dilated cardiomyopathy. 

Cardiomyopathy is a medical term meaning, ‘heart muscle disease.’ Dilated cardiomyopathy (DCM) is the most common type and is classified as either ischemic (lack of blood supply) or non-ischemic. In patients with non-ischemic dilated cardiomyopathy (NIDCM), the heart becomes enlarged and cannot pump blood effectively. As the heart stretches, the walls of the heart chambers become thinner and weaker, which over time can lead to heart failure and death. Common symptoms include shortness of breath, fatigue and swelling of the ankles, feet, legs, abdomen and veins in the neck. DCM also can lead to other problems such as heart valve disease, arrhythmias (irregular heartbeats) and blood clots in the heart. 

This study

Cellular therapy for chronic heart failure represents a potentially important alternative for this disease. Stem cells are cells that do not yet have a specific function in the body. Human mesenchymal stem cells (hMSCs) are a type of stem cell that can be grown from human bone marrow. Stem cells can develop into other types of more mature cells, such as blood and muscle cells. When cells are taken from a healthy donor (who is not the patient) it is called allogeneic. It is hoped that by placing these cells in the heart, they will allow the heart to work better.

This research study is being conducted to determine whether giving allo hMSCs to patients with heart muscle damage is safe. We will also examine whether this study drug improves heart function and if an individual’s genotype (genetics) plays a role in determining his/her response to allo hMSC therapy.

More information regarding this trial at www.clinicaltrials.gov.

To learn more about this trial in Louisville, contact:

Heidi Wilson
heidi.wilson@louisville.edu 

Previous clinical trials led by our team have demonstrated that stem cells taken from the patient’s own heart or bone marrow are capable of improving the outcome of patients with heart failure caused by ischemic cardiomyopathy or by the toxic effects of anti-cancer medicines in cancer survivors. These discoveries open exciting therapeutic options and could revolutionize the practice of cardiology.

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