Baxter International (NYSE:BAX) launched a Phase III pivotal trial of adult stem cell therapy for treating a heart condition called chronic myocardial ischemia.
Baxter hopes to use patients’ own stem cells to restore blood flow in CMI, 1 of the most severe forms of coronary artery disease which often doesn’t respond to medical management or surgery.
The trial will cover 450 patients to determine whether the stem cells can help repair the heart and restore a patient’s exercise capacity over a year. There is no current estimate for the timeframe for total enrollment, a company spokeswoman told MassDevice.
The patients will be enrolled into 1 of 3 arms of the randomized study: Treatment with stem cells, treatment with placebo and treatment with the current standard of care.
Patients in the stem cell arm will receive a single stem cell treatment comprised of 10 injections into targeted ares in the heart, according to a press release. The cells are derived from the patient’s bone marrow and made of endothelial progenitor cells, which develop into new blood vessels.
The study was initiated on the strength of a Phase II trial showing that the stem cell therapy may improve exercise capacity and reduce episodes of angina among the patient population.
"The Phase II trial provided evidence that this strategy, leveraging the body’s own natural repair mechanisms, can improve exercise capacity and reduce chest pain, the 1st time these endpoints have been achieved in a population of patients who have exhausted conventional treatment options," new therapeutic development VP Dr. Douglas Losordo said in prepared remarks.
That’s more good news for Baxter, which saw its stock rise on Wall Street after posting 4th-quarter sales and earnings in line with analysts’ expectations.
Shares were up 14 cents today to $58.09 as of about 1 p.m.