(HealthDay News) – Intracoronary infusion of cardiosphere-derived cells (CDCs) after myocardial infarction (MI) is safe and improves cardiac function, according to a phase 1 study published online Feb. 14 in The Lancet.
Raj R. Makkar, MD, from the Cedars-Sinai Heart Institute in Los Angeles, and colleagues assessed the safety of CDC in patients with left ventricular dysfunction after MI. Twenty-five patients, two to four weeks after MI, were enrolled and allocated to receive CDCs (17 patients) or standard care (eight patients) and were included in a per-protocol analysis. For patients in the CDC group, autologous cells grown from endomyocardial biopsy specimens yielded prescribed cell doses within 36 days and were infused into the infarct-related artery 1.5 to 3 months following MI.
The investigators found that no complications were reported within 24 hours of CDC infusion. By six months, none of the patients had died, developed cardiac tumors, or had a major adverse cardiac event. Serious adverse events occurred in four patients in the CDC group compared with one in the control group (P=1). At six months, magnetic resonance imaging analysis of patients treated with CDCs showed significant reductions in scar mass, increases in viable heart mass and regional contractility, and regional systolic wall thickening, compared with controls. There were no significant differences between the two groups at six months in end-diastolic volume, end-systolic volume, or left ventricular ejection fraction.
“We show intracoronary infusion of autologous CDCs after myocardial infarction is safe, warranting the expansion of such therapy to phase 2 study,” the authors write.
Several authors disclosed financial ties to Capricor, which develops and commercializes cardiac stem cells.