ROCHESTER, Minn. — Mayo Clinic researchers and international collaborators have discovered in a late-stage multinational clinical trial that a stem cell-based treatment improves the quality of life for patients with advanced heart failure. In one of the largest studies of cellular intervention after a heart attack, patients reported reduced daily difficulties when stem cells optimized for heart repair supplemented standard treatment. This clinical study further demonstrated lower mortality and hospitalization rates for patients treated with cell therapy. The study is published in the journal Stem Cells Translational Medicine.
“In this era of global aging, people are living longer but are at risk of chronic diseases that reduce their quality of life. Heart failure is an emerging epidemic that requires new treatments. ” said Andre Terzic, MD. , a cardiovascular researcher at the Mayo Clinic and lead author of the paper. “The stem cell-based approach in this study demonstrates that in response to biological therapy, it can provide lasting benefits for physical and mental health,” said Dr. Terzic, Director of Comprehensive Cardiac Regenerative Medicine at the Center for Regenerative Biotherapy. Marriott He is the director of his family.
Approximately 800,000 people in the United States suffer from a heart attack each year. Damage to the heart muscle weakens the heart’s ability to pump blood around the body, causing heart failure, a debilitating and life-threatening disease. People with heart failure often suffer from decreased quality of life, including shortness of breath, fatigue, swelling of the legs, and limitations in daily activities. Standard treatment for heart failure includes a heart-healthy diet and habits, medications, implantable devices, and rehabilitation. However, current treatments are not effective for everyone, especially those in advanced stages of the disease.
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The research team recruited 315 patients from 39 hospitals in 10 countries who suffered from advanced heart failure despite receiving standard treatment. Patients were randomly divided into groups that received stem cell therapy and those that did not. Patients assigned to cell therapy underwent cardiac catheterization. Stem cells taken from his own bone marrow and programmed to heal damaged heart tissue were then delivered to his heart. Patients assigned not to receive stem cells underwent cardiac catheterization without cell delivery, known as sham treatment.
All participants were asked to complete a 21-question self-assessment at the beginning of the study and again at 26, 39, and 52 weeks after treatment. For each question, they rated their physical, behavioral, and emotional state on a scale of 0 to 5.
During a 1-year follow-up, patients with pre-existing left heart chamber enlargement consistently reported improved quality of life after cell therapy compared to patients who received sham treatment. At the same time, lower mortality and hospitalization rates were recorded in people who received stem cells.
“Data from the largest cardiovascular cell therapy trial testing a regenerative technology discovered at Mayo Clinic shows both quality and quantity of life benefits in advanced heart disease.” Satsuki Yamada, MD, says: She is a cardiovascular researcher and lead author of the study. “The benefits of regenerative medicine have typically been evaluated based on clinician-reported outcomes. What makes this study unique is that it was designed to listen to patient experiences.”
The clinical trial was conducted in a double-blind manner, with both participants and their healthcare workers wearing masks during the research tasks. Double-blind studies are designed to reduce the risk of bias when assessing patient outcomes.
Further independent clinical studies are needed to validate the findings of this study.
Funding was provided by the J. Willard and Alice S. Marriott Foundation and the National Institutes of Health (R01 HL 134664). Additional support was provided by the Mayo Clinic Van Cleve Cardiac Regenerative Medicine Program, the Louis V. Gerstner Jr. Foundation of Vanguard Charities, the Tanoto Foundation, and the Mayo Clinic Center for Regenerative Biotherapy.
Please review the study for a complete list of authors, disclosures, and funders.
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