Results from a PI clinical study found that the delivery of Athersys' (NASDAQ:ATHX) MultiStem was safe and well tolerated in patients who had recently suffered an acute myocardial infarction (AMI).
The objective of the trial was to evaluate the safety of MultiStem administered by catheter delivery into the heart of patients that had recently suffered an AMI, resulting in severely compromised heart function.
- The data suggested improved cardiovascular performance, particularly among patients with severely compromised heart function;
- Data from the study demonstrate that delivery of MultiStem appeared safe, and did not result in any clinically significant changes in vital signs, allergic reactions, or infusion-related toxicities. In addition, there were no cellular or humoral immune responses observed up to 4 months after MultiStem injection. Following treatment, patients who exhibited significant myocardial damage and received >=50 million cells demonstrated strong trends for improvement in both ejection fraction and left ventricular stroke volume during the follow-up period.
The Bottom Line: This is the first clinical study to date with cell therapy that replicates the significant improvements in heart function observed in animal models of AMI. These results provide an important basis for understanding the properties of MultiStem in AMI. Previously published preclinical studies of MultiStem have shown that administration of a single dose of MultiStem can convey therapeutic benefits through multiple distinct mechanisms, such as protecting and preserving at risk tissue in the heart, reducing inflammation, and promoting revascularization over time. These studies also show improvement in cardiac function and increased capillary density in the heart in both rodent and porcine models of AMI. The potential to repair injured regions of heart tissue by using this target-specific approach is most encouraging, and builds on previous studies with MultiStem.