Baxter initiates Phase III stem cell therapy trial for Chronic Myocardial Ischaemiad

Baxter has initiated a phase III pivotal clinical trial to evaluate the efficacy and safety of adult autologous (an individuals own) CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia (CMI).The trial will enroll approximately 450 patients across 50 clinical sites in the United States , who will be randomized to one of three arms: treatment with their own autologous CD34+ stem cells, treatment with placebo (control), or unblinded standard of care. The primary objective is to evaluate the efficacy of treatment with CD34+ stem cells to improve the functional capacity of patients with CMI, as measured by a change in total exercise capacity at 12 months following treatment.CD34+ cells, which are blood-forming stem cells derived from bone marrow, are comprised of endothelial progenitor cells (EPCs), which develop into new blood vessels. Previous preclinical studies investigating these cells have shown an increase in capillary density and improved cardiac function in models of myocardial ischemia.