MedStar Heart & Vascular Institute has enrolled its first patient to a clinical trial to determine whether cardiac stem cells reduce inflammation enough to improve heart function in patients with heart failure severe enough to require a left ventricular assist device, or LVAD. STEMVAD is a randomized, double-blinded, placebo-controlled study that will assess the effects of multiple intravenous administration of CardioCell's proprietary mesenchymal stem cells (MSCs). It is expected to enroll 30 patients.
The STEMVAD trial is the next step in MedStar Heart & Vascular Institute's earlier research that discovered "one of the major problems in heart failure is persistent inflammation," said Stephen Epstein, MD, director of Translational and Vascular Biology Research at MedStar Heart & Vascular Institute. "And these mesenchymal stem cells control inflammation, leading to improved heart function."
Approximately six and a half million adult Americans have heart failure, of whom 200,000 to 250,000 are estimated to have end-stage heart failure and need a heart transplant. However, with the very low supply of donor hearts, LVADs are increasingly used. 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 have a high incidence of serious complications.
Innovative therapies to improve heart function and outcomes of patients with advanced heart failure are sorely needed.
Selma Mohammed, MD, PhD, Research Director of the Advanced Heart Failure Research Program at MedStar Heart & Vascular Institute.
If we are successful in showing intravenously delivered stem cells improve outcomes in patients, the results would likely extend to the general population of heart failure patients, and in the process, fundamentally transform current paradigms for treating heart failure.
Ron Waksman, MD, Director of Cardiovascular Research and Advanced Education at MedStar Heart & Vascular Institute.