LVAD Patients Benefit from Heart Injection with Millions of Powerful Cells
New Study results presented at AHA Scientific Sessions 2013 show a single dose of stem cell therapy during surgery may improve new LVAD patients' heart function.
A multicenter team of researchers within the NIH-funded Cardiothoracic Surgical Trials Network (CTSN), led by Icahn School of Medicine at Mount Sinai, have found end-stage heart failure patients who receive a surgically implanted left ventricular assist device (LVAD) heart pump may also benefit from a single dose of millions of powerful cells injected directly into their heart during surgery.
The CTSN, whose Data and Clinical Coordinating Center is at Icahn School of Medicine at Mount Sinai, conducted the clinical trial in collaboration with the Cardiovascular Cell Therapy Research Network.
Allogeneic mesenchymal precursor cells (MPCs), are a subpopulation of adult mesenchymal stem cells, which when harvested from a healthy donor's bone marrow can be selected and expanded in the laboratory into hundreds of millions of MPCs.
At the American Heart Association Scientific Sessions 2013 on November 18, Icahn School of Medicine at Mount Sinai's research team presented the new findings for this novel, first-ever randomized, double-blinded multicenter trial assessing the safety and efficacy of injecting a single dose of 25 million MPCs directly into the heart muscle of advanced heart failure patients receiving an LVAD for either bridge-to-transplant or as a destination therapy.
Study results show one dose of the MPC therapy may contribute to improved heart muscle recovery in advanced heart failure patients who received an LVAD. In their study, researchers reported that 50 percent of patients who received MPCs were able to tolerate temporarily turning down their LVAD heart pump, compared to 20 percent of the placebo patients. In addition, no patients developed serious side effects that may be associated with the stem cell injections.
"These clinical trial results provide important data about the safety and potential efficacy of a single MPC injection at the time of LVAD implantation,” says the study's lead author Deborah D. Ascheim, MD, Associate Professor of Health Evidence and Policy and Cardiology at Icahn School of Medicine at Mount Sinai, who serves as Co-Director of the Data and Clinical Coordinating Center based at Mount Sinai for the NIH-sponsored Cardiothoracic Surgical Trials Network (CTSN) who conducted the clinical trial study.
"These mesenchymal precursor cells have shown their potential to safely facilitate early heart tissue repair in advanced heart failure. We look forward to investigating the benefits of this cell therapy further,” says Dr. Ascheim.
The thirty LVAD patients enrolled in the clinical trial were randomized 2:1 at 11 clinical sites to evaluate the single dose injection of MPCs. Patients were assigned to either receive an injection of 25 million MPCs, or a placebo. All patients were followed until a heart transplant was received or until one-year.
The CTSN has eight core clinical centers across the country. It's Data and Clinical Coordinating Center, based at Icahn School of Medicine at Mount Sinai, leads each of its clinical trial's design, methodologies, ethical research concerns, study data, analysis, and data reporting.
The company that makes this experimental MPC therapy is Mesoblast, Inc.
This study was presented at the AHA Scientific Sessions as a Clinical Science Special Report (Abstract 19673): Intramyocardial Injection of Allogeneic Mesenchymal Precursor Cells in Left Ventricular Assist Device Patients.
About the Mount Sinai Health System
The Mount Sinai Health System is New York City's largest integrated delivery system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai's vision is to produce the safest care, the highest quality, the highest satisfaction, the best access and the best value of any health system in the nation. The Health System includes approximately 7,480 primary and specialty care physicians; 11 joint-venture ambulatory surgery centers; more than 410 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and 31 affiliated community health centers. The Icahn School of Medicine is one of three medical schools that have earned distinction by multiple indicators: ranked in the top 20 by U.S. News & World Report's "Best Medical Schools", aligned with a U.S. News & World Report's "Honor Roll" Hospital, No. 12 in the nation for National Institutes of Health funding, and among the top 10 most innovative research institutions as ranked by the journal Nature in its Nature Innovation Index. This reflects a special level of excellence in education, clinical practice, and research. The Mount Sinai Hospital is ranked No. 18 on U.S. News & World Report's "Honor Roll" of top U.S. hospitals; it is one of the nation's top 20 hospitals in Cardiology/Heart Surgery, Gastroenterology/GI Surgery, Geriatrics, Nephrology, and Neurology/Neurosurgery, and in the top 50 in six other specialties in the 2018-2019 "Best Hospitals" issue. Mount Sinai's Kravis Children's Hospital also is ranked nationally in five out of ten pediatric specialties by U.S. News & World Report. The New York Eye and Ear Infirmary of Mount Sinai is ranked 11th nationally for Ophthalmology and 44th for Ear, Nose, and Throat. Mount Sinai Beth Israel, Mount Sinai St. Luke's, Mount Sinai West, and South Nassau Communities Hospital are ranked regionally.