Cell therapy first for chronic heart failure
Posted: 28 February 2023 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
In a Phase III trial, a new cell therapy has shown potential for the first time to treat inflammation, a major contributor to heart failure.
The largest cell therapy trial to date for chronic heart failure due to low ejection fraction (EF), has shown that mesenchymal precursor cells (MPCs) have potential for the first time to address inflammation.
“This study examined the effects of [MPCs] a specific type of stem cell obtained from the bone marrow of healthy adult donors,” the study’s lead author, Dr Emerson C Perin, PhD, FACC, Medical Director at The Texas Heart Institute shared with EPR.
For the first time, we’ve discovered that stem cells can successfully treat the inflammation that causes heart failure.”
“For the first time, we’ve discovered that stem cells can successfully treat the inflammation that causes heart failure. In the simplest terms, the stem cells are injected directly into the heart muscle and shut down inflammation and begin to heal the cells,” he summarised. Based on the findings, Dr Perin explained to EPR that the trial is significant because the condition “currently is not addressed with medications, which treat the symptoms.”
In findings published in the Journal of the American College of Cardiology, the “stem cell therapy reduced the risk of heart attack and stroke and improved the heart’s pumping ability, especially in patients who have high levels of inflammation.” The treatment, Perin observed, gave patients a “58 percent reduced risk of heart attack or stroke, and the benefits rose to 75 percent in patients with high inflammation.”
“the MPCs can protect cardiac muscle cells from dying and can improve blood flow and energetics. In large blood vessels throughout the body, the reduced inflammation resulting from the activation of MPCs may decrease plaque instability, which is what leads to heart attacks and strokes,” explained Dr Perin.
The Phase III trial for chronic heart failure
The Phase III trial, DREAM-HF (Double-Blind Randomized Assessment of Clinical Events With Allogeneic Mesenchymal Precursor Cells in Heart Failure), assesed the effects of MPCs on the number of hospitalisations and major adverse cardiovascular events in heart failure.
The 565 patients were also on standard-of-care heart failure treatment. Therefore, the results suggest that the effect of the cell therapy was synergistic with and additive to state-of-the-art heart failure medications.
MPC-treated patients showed significant strengthening of the left ventricular muscle within the first 12 months. This was determined by an increase in left ventricular ejection fraction, which measured the heart’s pumping ability—one of the metrics used to assess overall heart function.
Long-term potential of the stem cell therapy
The results help to identify those heart failure patients with inflammation at greatest risk and most likely to benefit from MPC therapy. The findings will be confirmed in future studies.
“As the largest cell therapy trial in patients with heart failure to date, this study provides new insights into how cell therapy works, including both local and systemic effects, and can serve as a roadmap for other uses for conditions caused by inflammation, such as atherosclerosis,” Dr Perin told EPR.
He concluded that the trail results revealed long-term improvements in outcomes for patients with heart failure and are an important milestone in the field of cardiac cell therapy.
Biologics, Biopharmaceuticals, Clinical Development, Drug Development, Research & Development (R&D), Therapeutics