https://www.texasheart.org/texas-heart-institute-presents-paradigm-shifting-late-breaking-heart-failure-therapy-research-at-american-heart-association-annual-meeting/

Texas Heart Institute Presents Paradigm-Shifting Late Breaking Heart Failure Therapy Research at American Heart Association Annual Meeting

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 Association2021 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.

The study’s findings presented by Dr. Perin have been submitted for publication.