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Stem Cells Shown to Improve Heart Failure Health Outcomes

EKG graphic

(PublicDomainPictures, Pixabay)

5 April 2016. Results from a clinical trial show a new therapy for heart failure using patients’ own blood-forming stem cells reduces worsening symptoms, hospitalizations, and deaths. Findings of the study testing the treatments developed by biopharmaceutical company Vericel Corp., which funded the trial, appear in today’s issue of the journal The Lancet (paid subscription required).

Heart failure is a condition where the heart cannot pump enough blood to meet the body’s needs, a condition affecting some 5.7 million people in the U.S. The treatments developed by Vericell address one form of heart failure, known as ischemic dilated cardiomyopathy, where failure to pump enough blood is caused by weakness in the left ventricle, the heart’s main pumping chamber, resulting from lack of blood supply to the heart muscle, called ischemia. Patients with this condition often have few treatment options, other than a heart transplant or heart-pumping device.

The treatments develop by Vericel, known as ixmyelocel-T, use a small sample, about 50 milliliters, of a heart failure patient’s own bone marrow as the source for blood-forming stem cells, in a minimally-invasive out-patient procedure. With this sample, Vericel’s lab cultures promote the expansion of mesenchymal cells that can transform into a variety of mature cell types, as well as specialized therapeutic white blood cells.

The company, based in Cambridge, Massachusetts, says it can produce as much as 300 times the number of these cells as found in the original bone marrow. The therapeutic cells produced by ixmyelocel-T are then injected back with a catheter into the patient’s heart muscles to regenerate healthy heart tissue and improve the heart’s pumping ability.

The intermediate-stage clinical trial, led by Timothy Henry at Cedars-Sinai Heart Institute in Los Angeles and Amit Patel at University of Utah, tested ixmyelocel-T with 109 individuals having severe and end-stage heart failure from ischemic dilated cardiomyopathy. Participants were randomized to receive ixmyelocel-T  treatments or a placebo, then tracked for 12 months. The research team looked mainly at the rate of adverse health outcomes of the patients, including further hospitalizations from cardiac causes, unplanned out-patient or emergency-room visits related to heart failure, and deaths from any cause.

The findings show patients receiving the treatments fared better than placebo recipients. Some 38 percent of patients receiving ixmyelocel-T treatments experienced adverse outcomes, compared to about half (49%) of those receiving the placebo. Among participants receiving ixmyelocel-T, 3 percent died and 38 percent had one or more heart-related hospitalizations. With placebo recipients, 14 percent died and 47 percent experienced heart-related hospitalizations. The company says there were fewer treatment-related adverse effects, mainly from the injections or use of a catheter, among treatment than placebo recipients.

In addition to The Lancet publication, results of the trial were presented by Henry yesterday (4 April) at a meeting of American College of Cardiology.

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