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A 62-year-old New York City man is the first person to participate 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)—a severe form of coronary artery disease characterized by a shortage of blood supply to the heart; CMI 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 (the study is designed so that two-thirds of enrolled patients receive stem cells and one-third receive 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."

Representing the first such procedure for the New York City—area, the therapy also will be offered locally at NewYork-Presbyterian Hospital/Weill Cornell Medical Center.

"In a non-surgical 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/Weill Cornell Medical Center and associate professor of medicine at Weill Cornell Medical College.

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

Designed to evaluate efficacy, tolerability and safety, the new study is open to adult patients with a severe form (CS functional class III or IV) of chronic refractory angina that is unsuitable for conventional treatment (additional criteria apply).

Led by Dr. Douglas Losordo at Northwestern Memorial Hospital and Northwestern University's Feinberg School of Medicine in Chicago and ongoing at 18 sites nationally, the study is sponsored by the Cellular Therapies business unit of Baxter Healthcare Corporation, whose ISOLEX 300i Magnetic Cell Selection System is used to isolate the CD34+ stem cells that are being investigated in this clinical trial.

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.

Coronary Artery Disease and Chronic Myocardial Ischemia

Coronary artery disease is the most common form of heart disease and is the leading cause of death in the United States. This condition occurs when the coronary arteries and the smaller vessels that supply oxygen-rich blood to the heart muscle become narrowed or blocked by plaque deposits and blood clots. Poor blood flow and blood clots "starve" and injure the heart muscle. Chronic myocardial ischemia or a chronic blood supply shortage develops when the coronary arteries become so diseased that they limit the flow of blood to the heart and send small blood clots downstream, blocking the small blood vessels in the heart. These blockages can result in a series of minor heart attacks that, while they may be too small to notice at the time, in aggregate cause significant long-term damage to the heart muscle and disability to the patient. While cardiologists can restore blood flow in some cases, the heart muscle can be irreversibly damaged, leading to significant disability, progressive heart failure and sudden death.

NewYork-Presbyterian Hospital

NewYork-Presbyterian Hospital—based in New York City—is the nation's largest not-for-profit, non-sectarian hospital, with 2,224 beds. It provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, Morgan Stanley Children's Hospital of NewYork-Presbyterian, NewYork-Presbyterian Hospital/Allen Pavilion and NewYork-Presbyterian Hospital/Westchester Division. One of the largest and most comprehensive health-care institutions in the world, the Hospital is committed to excellence in patient care, research, education and community service. It ranks sixth on U.S.News & World Report's guide to "America's Best Hospitals," has the greatest number of physicians listed in New York magazine's "Best Doctors" issue, and is included among Solucient's top 15 major teaching hospitals. The Hospital has academic affiliations with two of the nation's leading medical colleges: Joan and Sanford I. Weill Medical College of Cornell University and Columbia University College of Physicians and Surgeons.

Columbia University Medical Center

Columbia University Medical Center provides international leadership in pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, nurses, dentists, and public health professionals at the College of Physicians and Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. For more information, visit www.cumc.columbia.edu.