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NeoStem Completes Enrollment in CV Trial

Autologous stem cell treatment could reduce post-heart attack costs healthcare burden

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

NeoStem, Inc. has completed enrollment in its PreSERVE AMI study. PreSERVE AMI is a randomized, double-blind placebo-controlled Phase II trial testing AMR-001, an autologous adult stem cell product for the treatment of patients with left ventricular dysfunction following acute ST segment elevation myocardial infarction (STEMI). With infusion of the target population of 160 patients complete, NeoStem expects data readout in 3Q14.

STEMI is the most dangerous type of myocardial infarction and is determined by an electrocardiogram test. In the U.S., there are more than 160,000 patients per year who suffer a STEMI, resulting from a sudden blockage of one of the arteries that supplies nutrient-rich blood to the heart muscle. STEMI patients are at a high risk of a progressive deterioration in heart muscle function that leads to arrhythmia, revascularization procedures, recurrent myocardial infarction, left ventricular dysfunction, congestive heart failure and premature death. Post-heart attack treatment of these patients represents a significant financial burden for many managed care programs. AMR-001, if approved, could provide a significant pharmacoeconomic benefit by preventing downstream cardiac adverse events, according to a NeoStem statement.

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