The Phase I clinical trial is an open label, multi-center dose escalation trial evaluating the safety and maximum tolerated dose of single dose administration of allogeneic MultiStem following an acute myocardial infarction (AMI).
Following standard treatment, enrolled patients receive MultiStem delivered via a Cricket micro-infusion catheter, a proprietary device developed and manufactured by Mercator Medsystems of San Leandro, California.
Athersys has evaluated the safety and ability of MultiStem to improve heart function in multiple animal models, including well-validated preclinical models of AMI. Based on this preclinical work, the company believes that MultiStem may be administered safely and has the potential to improve heart function in patients following severe heart attacks. Athersys is jointly developing MultiStem for AMI with Angiotech Pharmaceuticals.
William Lehmann, president and COO of Athersys, said: “We are excited about the potential of MultiStem to provide benefit in multiple diseases and conditions, and we look forward to providing additional information about this Phase I clinical trial and other studies as we move our programs ahead.”