The first randomized, placebo-controlled U.S. clinical trial to assess the use of bone marrow-derived mononuclear cells (BMC) in patients after a ST-elevation myocardial infarction (STEMI; severe heart attack) demonstrated a strong safety profile for this cell therapy, based on phase 1 results published in the September issue of the American Heart Journal.
"The use of adult stem cells, derived from the patient's own bone marrow, presents a potential new type of therapy to benefit individuals after they suffer a heart attack," says the study's principal investigator Jay H. Traverse, MD, cardiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital in Minneapolis, Minn. "Also, these types of stem cells do not possess any of the ethical concerns of embryonic stem cell research."
"While the objective of phase 1 clinical trials is to assess safety, researchers also look for hints of efficacy that have been revealed in previous studies," says Traverse. "Based on indications of some improvements in various European studies, we sought to examine whether this therapy could improve ejection fraction at six months, and whether it had an effect on attenuating adverse left ventricular remodeling as measured by cardiac MRI."
In this single-center trial, the researchers enrolled 40 patients with STEMI, randomizing them in a 3:1 ratio to 100 million autologous BMCs versus placebo, administered three to ten days following successful primary angioplasty and stenting of the left anterior descending coronary artery. Importantly, the researchers elected to deliver cells by an intracoronary infusion as opposed to the stop-flow technique that had been used in all preceding trials and all patients received an identical number of cells.
Administration of BMC was safely performed in all patients with minimal major adverse clinical event rates, and all patients remain alive to date, Traverse and colleagues reported.'/>"/>
|Contact: Meghan Bethke|
Minneapolis Heart Institute Foundation