Researching Effective Ways to Repair a Damaged Heart

Aurora Health Care Research

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Research at Aurora Health Care offers more than 700 clinical research opportunities including approximately 400 clinical trials. Through these studies, many of the 1.2 million patients served across Aurora are given access to new therapies, drugs and devices in the core service areas of cardiology, oncology, women's health and neurology. Randall Lambrecht, PhD, Senior Vice President of Research and Academic Relations, emphasizes, "Not only does Aurora offer innovative research opportunities it is also a clinical setting that is focused on improved patient outcomes and optimal delivery of health care."

Regenerative Medicine Using Stem Cells for Cardiovascular Disease

Approximately one million heart attacks occur in the United States each year and six million patients experience heart failure. There are limited repair mechanisms available for the effects of heart attacks and other damaging events. Without repair, heart tissue is replaced by scar tissue, resulting in an increased risk of death due to heart failure or arrhythmia. There is no effective therapy to replace dead or damaged heart tissue except with a heart transplant. However, a lack of heart donors makes transplant an inefficient therapy. Therefore, there is a need for a new, effective method to repair a damaged heart.

Regenerative medicine takes advantage of the body's ability to generate new tissue and fully restore the health of tissues damaged by disease. Multiple cell-based platforms have been developed, harnessing the regenerative potential of stem cells and other cells for heart repair. More than 1,000 patients on clinical trials received stem cell therapy for cardiovascular disease worldwide. There has been a favorable safety profile, a reduction in scarring in some studies and a modest improvement in heart function.

Regenerative Medicine Center at Aurora St. Luke's Medical Center

The Regenerative Medicine Center at Aurora includes a nationally recognized medical team including specialists in cardiac arrhythmia and heart failure, cardiac surgery, cardiovascular research, echocardiography (echo), interventional cardiology (catheterization), nuclear imaging, radiology, vascular medicine and vascular surgery. They are advancing health care by investing in basic and translational research and developing innovative stem cell and reparative therapies to improve patient outcomes. They are collaborating with national experts in regenerative cardiovascular medicine, inviting them to Aurora St. Luke's Medical Center to present their latest research findings. They also recently initiated two clinical research trials at Aurora St. Luke's Medical Center that offer regenerative medicine options for patients with cardiovascular disease, called the RENEW and PreSERVE-AMI trials.

RENEW Trial

The RENEW Trial at Aurora St. Luke's Medical Center is sponsored by Baxter International Inc. in Deerfield, Illinois. This trial is for patients who experience an average of 7 chest pain episodes a week despite maximal tolerated doses of medication and surgical interventions. The patient's own stem cells are harvested from his or her peripheral blood by expert hematologists/oncologists. These stem cells are handled by the Regenerative Medicine Center and prepared by Baxter International Inc. so that the cardiovascular specialists can inject either the patient's stem cells or a placebo into the muscle of the affected area of the heart. It is possible that the injected stem cells will develop into new blood vessels in the area of the blocked or damaged cardiac vessels to improve cardiac circulation and function. The research team seeks to improve functional capacity of the heart so the patient can perform daily tasks without incurring pain.

The research team includes cardiac specialists Steven C. Port, MD, and Tanvir Bajwa, MD, hematologists/oncologists and specialists from the Regenerative Medicine Center and Patient-Centered Research. There are 50 study locations in the United States and Canada; Aurora St. Luke's Medical Center is one of only two sites in Wisconsin participating in the trial. The study began in the fall of 2012. Patients are followed for two years.

PreSERVE-AMI Study

The PreSERVE-AMI trial at Aurora St. Luke's Medical Center is sponsored by Amorcyte LLC, a NeoStem Inc. company in Allendale, New Jersey. This trial is for patients who wish to prevent further damage to their heart following a specific type of heart attack called a ST-Elevation Myocardial Infarction (STEMI) where one of the heart's major arteries has been blocked. The STEMI patients have moderate to severe heart damage but have not yet experienced scarring. This short window of time between when a heart attack occurs and when the scarring begins provides an opportunity for patients potentially to benefit from adult stem cell therapy to preserve function in the area of the heart around the site of the attack.

In this study, the patient's own stem cells are harvested from his/her bone marrow by Aurora's expert hematologists/oncologists. The stem cells are handled by the Regenerative Medicine Center and prepared by Progenitor Cell Therapy, LLC so that the cardiovascular specialists can infuse the patient's stem cells (or a placebo) into the artery supplying blood to the damaged area of the heart. The research team is testing whether these procedures can prevent future major cardiac events by preventing further damage to the heart in the days, weeks and months following a heart attack.

The research team includes cardiac specialists Tanvir Bajwa, MD, and Suhail Allaqaband, MD, Anjan Gupta, MD, along with hematologists/oncologists and specialists from the Regenerative Medicine Center and Patient-Centered Research. Screening for the study began September 3, 2012 and is performed at Aurora St. Luke's Medical Center. There are at least 60 planned study locations in the U.S.; Aurora St. Luke's Medical Center is currently the only site in Wisconsin participating in the trial.

Cardiovascular Aging Research Team

Despite advanced age being recognized as the most important predictor of disability and death, the cellular mechanisms that increase the risk of heart disease in the elderly are not well understood. The Center for Integrative Research on Cardiovascular Aging (CIRCA) is working to understand the cellular mechanisms that lead to cardiovascular disease in the elderly and develop interventions to reduce such susceptibilities. This multidisciplinary team of researchers is headed by Arshad Jahangir, MD, Professor of Medicine and Chair of the Cardiovascular Research Committee, is conducting research in the Regenerative Medicine Center labs at Aurora St. Luke's Medical Center and will soon expand into labs in the Milwaukee Heart Institute at Aurora Sinai Medical Center. "Because of its commitment to providing state-of-the-art therapy to our patients, Aurora Health Care is able to offer stem cell therapy in attempts to improve myocardial performance and exercise capacity in patients with refractory angina and chronic myocardial ischemia, and to prevent future major adverse cardiac events via clinical research trials," Dr. Jahangir said.

The RENEW and PreSERVE-AMI stem cell studies are among the exciting innovative patient-centered research initiatives occurring at Aurora Health Care. Aurora plans to participate in additional regenerative medicine studies in the future.