(RTTNews.com) - Baxter International Inc. (BAX) said it has initiated a phase III pivotal clinical trial to evaluate the efficacy and safety of adult autologous CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia.
Chronic myocardial ischemia is one of the most severe forms of coronary artery disease, causing significant long-term damage to the heart muscle and disability to the patient.
The company said that the trial will enroll approximately 450 patients across 50 clinical sites in the United States, who will be randomized to one of three arms, namely 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 chronic myocardial ischemia, as measured by a change in total exercise capacity at 12 months following treatment.
Efficacy will be measured by a change in total exercise capacity during the first year following treatment and safety data will be collected for two years.
The company noted that the trial is being initiated based on the phase II data, which indicated that injections of patients' own CD34+ stem cells may improve exercise capacity and reduce reports of angina episodes in patients with chronic, severe refractory angina.
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Baxter Begins Phase III Adult Stem Cell Trial For Chronic Cardiac Condition