Clinical trial planning is underway at MedStar Heart & Vascular Institute to determine whether a novel stem cell therapy will improve heart function for patients with heart failure. MedStar Heart, in partnership with CardioCell, a subsidiary of Stemedica Cell Technologies, pioneered the use of stem cells in regenerative medicine. The trial will use CardioCell's proprietary mesenchymal stem cells (MSCs), manufactured by Stemedica. The goal is to improve outcomes in patients with heart failure and left ventricular assist devices (LVADs).
MedStar Heart & Vascular Institute has been studying the causes of the progressive deterioration of heart function that patients with heart failure experience over time, as well as the potential therapeutic role of stem cells. "We have developed compelling evidence that one of the major mechanisms leading to progressive myocardial dysfunction in patients with heart failure is the presence of persistent and inappropriate inflammation," said Stephen Epstein, MD, director of Translational and Vascular Biology Research at MedStar Heart & Vascular Institute. "Of great therapeutic relevance is the fact that mesenchymal stem cells have marked anti-inflammatory effects." Dr. Epstein and his colleagues demonstrated in mouse models of heart attack and of heart failure that intravenously administered MSCs lead to a magnitude of improved heart function that is unprecedented.
"This study, if successful, will lead to pivotal trials that, in turn, will have the potential to alter strategies of treating LVAD patients that could markedly improve their symptoms and outcomes," added Steven Boyce, MD, surgical director of the Advanced Heart Failure program at MedStar Heart & Vascular Institute.
There are nearly six million Americans with heart failure, and about 650,000 new cases occur each year. Each year 200,000 to 250,000 heart failure patients need heart transplantation, but with the very low supply of donor hearts, LVADs are being used with increasing frequency. An LVAD is a small pump that helps circulate the patient's blood when their heart becomes too weak to pump effectively on its own. Although highly effective in alleviating symptoms and improving longevity, patients with LVAD support still have a high incidence of serious complications, including a high mortality rate. Persistent inflammation is also a probable major cause of deterioration of LVAD patients.
"If we are successful in showing stem cells improve outcomes in LVAD patients, the results would extend to the general population of heart failure patients and, in the process, fundamentally transform current paradigms for treating heart failure patients," Dr. Epstein concluded.