AMR-001, bone marrow-derived CD34+ cells for myocardial infarction

AMR-001, an autologous bone marrow-derived, CD34+ selected stem cell product is infused via the infarct–related artery to patients after ST segment elevation myocardial infarction (STEMI). The company completed a Phase I clinical trial which raised no safety concerns and established a biological threshold dose with statistical significance in patients who experience a STEMI. Specifically, at doses ≥10 million CD34+ cells demonstrating SDF-1 mobility, there was a significant improvement in infarct region perfusion, trend to improvement in left ventricular ejection fraction (LVEF), and lower incidence of decreased LVEF at 6-month follow-up compared with patients in the control group and those receiving 5 million cells.