National Cell Therapy Network Reports Results of Heart Failure Study

Autologous bone marrow‐derived mesenchymal stromal cells (MSCs) and ckit positive cardiac cells (CPCs) show promise in Phase II study

HOUSTON, TX – May 5 – Despite significant medical and surgical advances, patients with chronic heart failure caused by ischemic cardiomyopathy have very limited treatment options today. As a result, they continue to experience a low quality of life, and about half will die within five years of receiving the diagnosis. The CONCERT-HF trial was the first multicenter trial to assess the combination of two cell types from different tissues in heart failure patients. The results published in the European Journal of Heart Failure were encouraging and showed that treatment is both safe and feasible.

The CONCERT-HF study launched in 2016 was initiated to determine whether two types of stem cells derived from bone marrow and cardiac tissue were safe and beneficial to administer as a treatment to chronic heart failure patients. The study was funded by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH).

In this randomized, double-blind, placebo-controlled phase II trial, 125 participants were enrolled from seven centers in the United States. Participants were randomly assigned to receive one of four treatments: a combination of c-kit positive cardiac stem cells (CPCs) and mesenchymal stem cells (MSCs), CPCs alone, MSCs alone, or placebo.

The participants in the study had tissue and bone marrow collected to prepare the cell-based products to be administered. These products or placebo (dependent on the participant’s assignment) were injected directly into the heart through a catheter.

The study participants were required to have six follow-up visits within one year of receiving the study product where doctors ran tests to determine the effects on exercise capability, quality of life, and changes in the heart’s ability to pump blood.

“Even with maximal guideline‐directed therapy, both CPCs and MSCs were associated with measurable effects; albeit in different ways without affecting left ventricular function or structure. CPCs were associated with improved major clinical outcomes and MSCs with improved quality of life in patients with ischemic heart failure,” according to Dr. Emerson Perin, co-principal investigator of the multi-center study.

The study provides support for further investigations into the possible systemic or paracrine cellular mechanisms of these effects.

“ Our ultimate goal is to advance cell therapy by conducting comparative studies of multiple cell types to help identify the most effective cell types in heart failure and this study moves the needle in the right direction for patients,” added Dr. Perin.

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The Texas Heart Institute, founded by world-renowned cardiovascular surgeon Dr. Denton A. Cooley in 1962, is a nonprofit organization dedicated to reducing the devastating toll of cardiovascular disease through innovative and progressive programs in research, education, and improved patient care. THI’s scientists and physicians conduct fundamental biomedical, translational, and clinical research in cardiology, cardiovascular surgery, molecular-based medicine, stem cell, and gene therapy, and regenerative medicine both independently and in collaboration with organizations worldwide. As global leaders of patient care for nearly six decades, Texas Heart Institute has been ranked among the top cardiovascular centers in the United States by U.S. News & World Report for the past 30 years. THI is dedicated to spreading awareness and sharing updates on ways to prevent, treat and defeat cardiovascular disease. With over 10 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.

 


Bolli, R et al. A Phase II Study of Autologous Mesenchymal Stromal Cells and c‐kit Positive Cardiac Cells, Alone or in Combination, in Patients with Ischemic Heart Failure: The CCTRN CONCERT‐HF Trial April 2021 European Journal of Heart Failure DOI:10.1002/ejhf.2178

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