Pivotal trial begins for stem cell therapy
March 6, 2012
Baxter International said this week that it had begun a phase III, placebo-controlled trial of autologous stem cells to boost cardiac function in people with chronic refractory angina.
The CD34-positive stem cells will be harvested from patients' blood and, after processing ex vivo, injected directly into targeted areas of the heart muscle, Baxter said. Ten injections will be delivered in a single treatment session.
In phase II studies, the treatment improved exercise capacity and reduced angina episodes in patients with chronic, severe, and treatment-resistant angina.
The trial is slated to recruit about 450 patients at 50 clinical sites. The primary outcome measure will be change in total exercise capacity one year after treatment, relative to baseline.
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