THI Medical Director Emerson C. Perin, MD, PhD, outlines Phase 3 Clinical Trial Results Demonstrate Promising Stem Cell Treatment Options for Patients with Persistent Heart Failure 

HOUSTON, TX (NOVEMBER 14, 2021) – The Texas Heart Institute has presented substantial research findings from a randomized, controlled 565-patient phase 3 clinical trial of individuals with class II and class III persistent heart failure at the American Heart Association 2021 Scientific Sessions gathering in Dallas, TX. Presented by the study’s co-principal investigator and Texas Heart Institute Medical Director Emerson C. Perin, MD, PhD, the primary takeaways include:

 

• Stem cell treatment reduced death related to cardiovascular issues by 80% in those with high levels of inflammation and less damaged hearts (NYHA class II heart failure).
• In heart failure with high levels of inflammation, heart attack and stroke numbers dropped 79% after stem cell treatment.
• All patients with heart failure treated with stem cells experienced a 65% reduction in non-fatal heart attack or stroke events.
• Adults with heart failure who received stem cell treatment did not see a reduction in recurrent, decompensated heart failure events.

 

“I am extremely encouraged by these clinical findings and their possible impact on how we treat heart failure in the future,” Dr. Perin stated. He added, “This cell therapy uniquely targets inflammation as a core mechanism of the disease and is designed to be an additive treatment option to what is already the best evidence-based heart failure medicines available to patients. To that end, when you think about adding cell therapy to current options prescribed by cardiologists, we now have an entirely new weapon for combating the deleterious effects of persistent heart disease.”

 

The groundbreaking program set out to examine the effects of using stem cells, specifically mesenchymal precursor cells (MPCs), injected directly into the heart to target inflammation and treat persistent heart failure. For the study’s primary investigative endpoint, the research team set out to deduce whether a single intracardiac injection procedure of stem cells from healthy adult donors given in addition to standard-of-care heart failure treatment would affect the number of times participants were hospitalized for heart failure events. Secondary outcomes included whether study participants had a reduction in heart attack, stroke, or death.

 

Sponsored by biotechnology company Mesoblast, a world leader in developing allogeneic cellular medicines, the DREAM-HF trial is the largest cell therapy study in people with heart failure conducted to date. “The results of this study show that our allogeneic, industrially-manufactured MPC product candidate, rexlemstrocel-L, may provide an innovative therapeutic approach to address inflammation as a central mechanism in persistent heart failure. This has the potential to alter the natural history of this disease, which continues to have a high mortality despite existing pharmacological treatments,” said Dr. Silviu Itescu, Chief Executive of Mesoblast.

 

The research findings from Dr. Perin and his team of co-authors add to the Texas Heart Institute’s formidable legacy of pioneering breakthroughs in the field of cardiology, including the first successful heart transplantation performed in the United States and the first implantation of a total artificial heart into a human being.

 

“The Texas Heart Institute prides itself upon consistently striving to uncover The Next First in cardiovascular discovery and treatment,” emphasized President & CEO Dr. Joseph G. Rogers. He added, “The phase 3 clinical trial findings put forward by Dr. Perin to the American Heart Association speak to the relentless pursuit of excellence that THI researchers dedicate themselves to by spending countless hours investigating novel ways to improve the methods for treating heart failure in order to improve patient outcomes.”

 

The DREAM-HF study co-authors, in addition to Emerson C. Perin, MD, PhD, are Barry Greenberg, MD; Kenneth Borow, MD; Timothy Henry, MD; Farrell Mendelsohn, MD; Les Miller, MD; Elizabeth Swiggum, MD; Eric Adler, MD; Christopher James, PA, and Silviu Itescu, MD.

 

ABOUT TEXAS HEART INSTITUTE (THI)

Texas Heart Institute (THI), founded by world-renowned cardiovascular surgeon Dr. Denton A. Cooley in 1962, is a nonprofit organization dedicated to delivering the future of cardiovascular health through exceptional patient care, discovery, and a commitment to learning. Participating in research programs in cardiology, cardiovascular surgery, stem cell and gene therapy, and regenerative medicine, THI’s scientists and physicians are spearheading some of the most innovative research in the medical field. Through its translational basic and clinical research programs, Texas Heart Institute is learning more every day about the underlying causes of heart disease and the ways to better treat and even prevent it. With initiatives ranging from postdoctoral and continued medical education to public outreach and scientific publications, THI is dedicated to spreading awareness and sharing updates on ways to prevent, treat and defeat cardiovascular disease. With over 12 million visitors coming to its website from around the world every year, www.texasheart.org is just one of the ways THI is helping to educate people on the importance of heart health.

 

For more information, please visit https://www.texasheart.org

 

ABOUT THE AMERICAN HEART ASSOCIATION (AHA)

The American Heart Association is a leading force for a world of longer, healthier lives. With nearly a century of lifesaving work, the Dallas-based association is dedicated to ensuring equitable health for all. We are a trustworthy source empowering people to improve their heart health, brain health, and well-being. We collaborate with numerous organizations and millions of volunteers to fund innovative research, advocate for stronger public health policies, and share lifesaving resources and information. Connect with us on heart.org, Facebook, Twitter or by calling 1-800-AHA-USA1. #AHA21

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Circulation. 2021;144(25):e564-e593. doi: 10.1161/CIR.0000000000001041. Epub 2021 Dec 20.

Late-Breaking Science Abstracts and Featured Science Abstracts From the American Heart Association’s Scientific Sessions 2021 and Late-Breaking Abstracts in Resuscitation Science From the Resuscitation Science Symposium 2021

17223: Randomized Trial of Targeted Transendocardial Delivery of Mesenchymal Precursor Cells in High-Risk Chronic Heart Failure Patients With Reduced Ejection Fraction; Emerson C Perin, Barry H Greenberg, Kenneth M Borow, Timothy D Henry, II, Farrell O Mendelsohn, Les R Miller, Elizabeth Swiggum, Eric D Adler, Christopher A James9, Silviu Itescu.

 

 

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MEDIA  Mark Sullivan 512 497-6177 / Jonathan Babin 713 557-5335 / Keri Sprung