As safety and efficacy programs advance, clinicians consider the investigative therapy's potential in cardiology.
There’s plenty more hurdles to clear, but stem cell therapy has progressed to state where it now features multiple ongoing phase 3 trial for cardiovascular use. Its benefit for heart failure may be recognized as soon as a couple of years.
In an interview with MD Magazine® while at the Heart Failure Society of America (HFSA) 2019 Scientific Sessions in Philadephia, PA, Joshua Hare, MD, director of the Interdisciplinary Stem Cell Institute at the University of Miami, provided an update on stem cell research in heart failure, and what benefits the investigative treatment could bring to certain patients.
MD Mag: What is the current state of stem cell research in heart failure?
Hare: It's a very exciting time right now, because we can look toward next year, to see the release of data from 2 or 3 major clinical trials.
The first phase 3 clinical trial of cell therapy for patients with cardiomyopathy and heart failure has completed enrollment, and we're expecting those results next year. There's also a very exciting trial called the CONCERT-HF trial, which was funded by the National Institutes of Health, that looks at a unique way to combine 2 types of cells to try and enhance the effect. So we're calling that combinatorial cell therapy for patients with ischemic cardiomyopathy and heart failure.
MD Mag: Relative to other indications, how does stem cell therapy figure to benefit heart failure?
Hare: Well, the underpinning of congestive heart failure is some kind of injury or damage to the heart. In many instances, it's a heart attack, where blood flow has stopped to the heart muscle and a part of the heart muscle has died, leaving a scar. That scar then causes a process of remodeling of the left ventricle. And the ventricle can blow up like a balloon.
In other words: the normal shape of the heart is a football, and that can become a basketball after myocardial infarction. When that occurs, there's all kinds of health issues that result. So in in the most advanced cases, we try to transplant that person. Take the old, injured heart out and replace it with a new one.
But the whole idea of cell therapy is that we can fix that injury without having to remove the whole organ, and just sit simply inject the cells into the areas of damage and injury, and allow those areas to heal and regrow some function of the heart muscle. So that's the goal.
MD Mag: Is there an ideal heart failure patient for stem cell therapy?
Hare: No, no. Certainly, if you develop any new therapy for a new area, it has to be targeted and focused on a specific type of disease. We are doing a variety of trials now, and in the future, that are targeted to a number of the key areas of need.
One would be ischemic cardiomyopathy, which is the patient that's had a heart attack and now has had a remodeled ventricle. That's a key area of focus. Another area of focus is a person or a patient that has idiopathic cardiomyopathy. The heart is not functioning and is injured due to reasons other than a heart attack.
And there's another important area that we're currently doing a study on—which is children who have congenital heart disease. These are kids were born with dysfunctional hearts, and these are very seriously ill kids. And they need a lot of surgery. But we're doing a study now to see if adding cell therapy into those surgical procedures can help the hearts heal and stay strong.