Weill Cornell participates in clinical trial that uses patients' own stem cells to repair damaged hearts

NEW YORK -- A 62-year-old New York City man is the first participant in a new clinical research trial at NewYork-Presbyterian Hospital/Columbia University Medical Center aimed at using patients' own stem cells to repair hearts damaged by chronic myocardial ischemia (CMI).

The therapy also will be offered in New York City at NewYork-Presbyterian Hospital/Weill Cornell Medical Center (WCMC).

CMI is a severe form of coronary artery disease characterized by a shortage of blood supply to the heart; it is resistant to other treatments like angioplasty, stenting and bypass surgery.

The Autologous Cellular Therapy CD34-Chronic Myocardial Ischemia (ACT34-CMI) trial is the nation's first Phase II study of adult stem-cell therapy for the condition. ACT34-CMI is a double-blind, placebo-controlled trial, which means that neither the patient nor the medical staff know if the man received his own stem cells or a placebo (two-thirds of enrolled patients will receive stem cells and one-third a placebo).

"We hope to show that patients have the means themselves -- namely their own stem cells -- to repair their hearts burdened by otherwise untreatable, and often painful, coronary disease," says Dr. Warren Sherman, site principal investigator and interventional cardiologist at NewYork-Presbyterian/Columbia and associate professor of medicine at Columbia University College of Physicians and Surgeons. "The key here is for us to help those cells find their way to the heart, where they may have important effects on heart function."

"In a nonsurgical procedure, the stem cells are injected directly into the affected areas of the heart, where they may stimulate the growth of new vessels, ensuring adequate nutrition for the heart muscle," adds Dr. Shing Chiu Wong, site principal investigator and interventional cardiologist at NewYork-Presbyterian Hospital/WCMC and associate professor of medicine at WCMC.

An earlier Phase I trial reported the therapy to be well tolerated without serious adverse events. Fifteen of the 18 patients receiving the cells reported feeling better, with reductions in chest pain and/or improved exercise capacity.

The study is sponsored by the Cellular Therapies business unit of Baxter Healthcare Corp. The American Heart Association estimates that every year, as many as 250,000 coronary artery disease patients develop chronic myocardial ischemia, which, if untreated, can lead to heart attack, heart failure and death.

For other news from Weill Cornell this week, see http://news.med.cornell.edu/wcmc/.

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