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Johns Hopkins Medicine Suburban - Research: FDA Authorizes New Stem Cell Trial

New Directions Winter 2012

Research: FDA Authorizes New Stem Cell Trial

Date: November 1, 2012

In conjunction with the NIH Center for Regenerative Medicine, the NIH Heart Center at Suburban Hospital is currently recruiting patients with severe coronary artery disease for an exciting new stem cell study. Patients approved for the study and undergoing coronary artery bypass grafting (CABG) or transmyocardial laser revascularization (TMR) will have stem cells harvested from their hip bone and injected into their heart muscle. “Based on research conducted in our laboratory, injecting stem cells into animals with damaged heart muscle was shown to improve the heart’s function,” says Keith Horvath, M.D., director of the Cardiothoracic Surgery Research Program at NHLBI and chief of cardiothoracic surgery at Suburban Hospital. “In using the patient’s own cells, there is no chance of rejection and the cells should improve the blood flow to the heart and aid repair of damaged heart muscle.”

Stem Cell Trial

Who: Patients with severe coronary artery disease and chest pain.

Purpose: To determine if stem cells harvested from the patient’s own bone marrow, delivered to the heart at the time of cardiac surgery, can improve the function of the heart after treatment.

The Cardiothoracic Surgical Trials Network

The NIH Heart Center at Suburban Hospital is also part of a unique network devoted solely to cardiovascular research that includes some of the nation’s top clinical centers. The Cardiothoracic Surgical Trials Network (CTSN) includes such prestigious institutions as Duke University, Cleveland Clinic, Columbia University and University of Pennsylvania, among others. Research teams led by cardiac surgeons evaluate newer therapies and surgical techniques as they move from laboratory science to broad clinical use, or as we like to say, “from the scientist’s bench, to the patient’s bedside.”

Two CTSN trials are currently enrolling patients at Suburban Hospital.

AFib Trial

1. Who: For people who have mitral valve disease (requiring surgery) and also atrial fibrillation.

Purpose: To determine whether surgical atrial fibrillation ablation performed during scheduled mitral valve surgery (surgery to repair a heart valve) is better than mitral valve surgery by itself without the surgical ablation. Surgical ablation of atrial fibrillation is a technique used by surgeons to create scars in atrial heart tissue that block electrical signals that may be causing the heart to beat irregularly.

Surgical Interventions for Moderate Ischemic Mitral Regurgitation

2. Who: For people who have coronary artery heart disease, requiring coronary artery bypass graft surgery (CABG), and have leakage (regurgitation) of the mitral valve.

Purpose: To determine whether repairing a mitral valve (a heart valve that helps control the flow of blood) with moderate leakage (regurgitation), at the time of planned (CABG) surgery, will improve health outcomes of those who have the repair compared to those who have the CABG surgery alone.

Early Warning for Heart Attack

This study sponsored by Angel Medical Systems is testing an experimental “early-warning” device for heart attack. Consisting of two parts—a generator implanted in the left upper chest wall and a pager-size portable alarm that remains external—the device can alert people to seek medical attention when it detects changes in the electrical signal from your heart that can indicate the earliest stage of a heart attack.


Who: For those who have had a heart attack or coronary artery bypass graft (CABG) surgery within the past six months or have CABG surgery planned in the next six months.

Purpose: Heart pain (angina) is often mistaken for something else: heartburn, indigestion, other GI discomfort, fatigue, anxiety, dental problems and the flu, to name a few. This technology could provide a sense of reassurance to patients with multiple medical problems.

For more information on cardiothoracic research trials, contact Mandy Murphy, clinical research nurse, at . To learn more about clinical trials at Suburban, visit Suburban Hospital Research.