February 3, 2017 — Physicians and researchers at Texas Heart Institute are recruiting patients who suffer from heart failure to participate in the first-ever clinical study of combination adult stem cell therapy in cardiovascular medicine. Adult cell therapy has been studied in patients with heart disease with an excellent safety profile, though a combination of two cell types has not yet been evaluated in cardiovascular disease.
Heart disease is the leading cause of death in the United States, with one in every four deaths attributable to the disease each year. In fact, it is estimated that approximately 6 million Americans are living with heart failure today and that half will die within five years of their diagnosis. Evidence suggests that certain types of adult stem cells can be used to reduce damaged heart tissue associated with heart failure and possibly generate new muscle that will allow the heart to work better.
“Preclinical studies have shown the ability of c-kit+ cardiac stem cells and mesenchymal stem cells to improve heart function,” said Emerson Perin, M.D., Ph.D., director of THI’s Stem Cell Center. “Although a combination therapy has not yet been evaluated, we are hoping to find that this treatment can improve on single cell therapies and provide new options for addressing this devastating disease.”
The CONCERT-HF trial (Combination of Mesenchymal and c-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure) will assess the benefits and risks of using two adult stem cell types – mesenchymal stem cells (MSCs) and c-kit+ cardiac stem cells (CSCs) – given alone or in combination to help treat patients with heart failure. The Cardiovascular Cell Therapy Research Network (CCTRN), of which Texas Heart Institute is a member, is conducting the trial.
CONCERT-HF is a randomized clinical trial that will evaluate heart function in four groups of patients: a) those treated with only MSCs from their own bone marrow; b) those treated with only CSCs from their own heart tissue; c) those treated with a combination of MSCs and CSCs from their own bone marrow and heart tissue; and d) those treated with placebo. All patients will be followed for one year.
The study began recruiting patients in November 2016 and is expected to enroll 144 patients over approximately two years. People who have had a heart attack or who are experiencing heart failure are being asked to participate in the study. Individuals can submit a patient information form to be screened for eligibility to participate.
For more information: www.texasheart.org