PUBLIC RELEASE DATE:

31-Mar-2014

Contact: Beth Casteel bcasteel@acc.org 202-375-6275 American College of Cardiology

WASHINGTON (March 31, 2014) Patients with severe ischemic heart disease and heart failure can benefit from a new treatment in which stem cells found in bone marrow are injected directly into the heart muscle, according to research presented at the American College of Cardiology's 63rd Annual Scientific Session.

"Our results show that this stem cell treatment is safe and it improves heart function when compared to placebo," said Anders Bruun Mathiasen, M.D., research fellow in the Cardiac Catherization Lab at Rigshospitalet University Hospital Copenhagen, and lead investigator of the study. "This represents an exciting development that has the potential to benefit many people who suffer from this common and deadly disease."

Ischemic heart disease, also known as coronary artery disease, is the number one cause of death for both men and women in the United States. It results from a gradual buildup of plaque in the heart's coronary arteries and can lead to chest pain, heart attack and heart failure.

The study is the largest placebo-controlled double-blind randomized trial to treat patients with chronic ischemic heart failure by injecting a type of stem cell known as mesenchymal stromal cells directly into the heart muscle.

Six months after treatment, patients who received stem cell injections had improved heart pump function compared to patients receiving a placebo. Treated patients showed an 8.2-milliliter decrease in the study's primary endpoint, end systolic volume, which indicates the lowest volume of blood in the heart during the pumping cycle and is a key measure of the heart's ability to pump effectively. The placebo group showed an increase of 6 milliliters in end systolic volume.

The study included 59 patients with chronic ischemic heart disease and severe heart failure. Each patient first underwent a procedure to extract a small amount of bone marrow. Researchers then isolated from the marrow a small number of mesenchymal stromal cells and induced the cells to self-replicate. Patients then received an injection of either saline placebo or their own cultured mesenchymal stromal cells into the heart muscle through a catheter inserted in the groin.

"Isolating and culturing the stem cells is a relatively straightforward process, and the procedure to inject the stem cells into the heart requires only local anesthesia, so it appears to be all-in-all a promising treatment for patients who have no other options," Mathiasen said.

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New human trial shows stem cells are effective for failing hearts