Patients’ Own Bone Marrow Used in Personalized Therapy
Morristown, NJ – Morristown Medical Center, part of Atlantic Health System, is the first and only hospital in New Jersey to enroll patients in the pivotal CardiAMP Heart Failure Trial. The Phase III clinical trial is enrolling patients who have heart failure following a heart attack to assess whether the investigational CardiAMP therapy can stimulate the body's natural healing response and improve cardiovascular function and/or quality of life.
The first procedure was performed by Robert Kipperman, MD, an interventional cardiologist and Co-Director of the Valve & Structural Heart Center at Morristown Medical Center. Marc Goldschmidt, MD, Director of the heart failure and left ventricular assist device programs for Morristown Medical Center and Atlantic Health System, will serve as the lead investigator for the trial at Morristown Medical Center. Mohamad Cherry, MD, Medical Director of Hematology, Atlantic Health System, performed the patient’s bone marrow harvest to obtain the stem cells.
Heart failure, a condition that affects an estimated 5.7 million people in the U.S., occurs when the heart is unable to pump enough blood to meet the body’s need for blood and oxygen. A common cause of heart failure is a heart attack, which damages and weakens the heart muscle.
The CardiAMP stem cell-based therapy takes a personalized and minimally invasive approach to the use of a patient’s own bone marrow cells in the treatment of ischemic heart failure that develops after a heart attack. Patients are screened for bone marrow characteristics that may result in a higher likelihood of their benefitting from the therapy, with likely responders receiving therapy directly to the damaged regions of the heart. Cell implantation is performed using the Helix system.
“The CardiAMP trial has the potential to improve the quality of life for countless adults diagnosed with heart failure, a number that the American Heart Association expects to rise by 46 percent by the year 2030,” said Dr. Goldschmidt. “As the home of New Jersey’s number one ranked cardiology and heart surgery program, Morristown Medical Center is proud to offer our patients another innovative therapy option and truly personalized treatment—with their own bone marrow cells.”
“The current treatment options for advanced heart failure include medications, heart transplant surgery or implantation of a left ventricular assist device (LVAD), but medication may not be completely effective, heart transplant and LVAD insertion are major operative procedures, and, in the case of heart transplantation, a very limited resource,” said Linda Gillam, MD, Dorothy and Lloyd Huck Chair, Department of Cardiovascular Medicine, Medical Director Cardiovascular Service Line, Morristown Medical Center/Atlantic Health System. “Morristown Medical Center is dedicated to bringing patients more minimally invasive treatment options, like CardiAMP, that can shorten recovery time and help patients return to their lives faster.”
About the CardiAMP Heart Failure Trial
The CardiAMP Heart Failure Trial is a phase III, multi-center, randomized, double-blinded, sham-controlled study of up to 260 patients at up to 40 centers nationwide. The primary endpoint for the trial is a significant improvement in Six Minute Walk distance at 12 months’ post-treatment. Other endpoints include major adverse cardiac and cerebrovascular events and mortality. Study subjects must be diagnosed with New York Heart Association (NYHA) Class II or III heart failure that has developed after a previous heart attack. Learn more about the trial >
The CardiAMP trial is sponsored by BioCardia, Inc.
About Heart Care at Atlantic Health System
The Gagnon Cardiovascular Institute at Morristown and Overlook Medical Centers, part of Atlantic Health System, is home to New Jersey’s largest cardiac surgery program, and provides patients with world-class medical experts and award-winning cardiovascular diagnostic and treatment services. Specializing in open-heart, minimally invasive and non-invasive procedures, Gagnon offers its patients individualized care at a hospital that was named one of America’s 20 Best Hospitals for Cardiology and Cardiac Surgery by U.S. News & World Report and one of America’s 100 Best Hospitals for Cardiac Care by Healthgrades. Nationally ranked in cardiology since 2012, the heart care team at Morristown Medical Center includes cardiologists with expertise in multiple disciplines, cardiac surgeons, vascular specialists and allied health professionals.
About Clinical Trials at the Gagnon Cardiovascular Institute at Morristown Medical Center
Because of its infrastructure to support research through the Atlantic Center for Research, volume, and earned credibility with the sponsors of trials—pharmaceutical, biotech, or medical device companies—Morristown Medical Center is able to offer cutting edge and novel clinical trials.
Clinical trials offer patients access to the latest treatment advancements. Though participation in a clinical trial may involve risks, research patients are monitored closely and at regular intervals in accordance with rigorous scientific criteria. The cardiac research team works in conjunction with strict United States Food and Drug Administration guidelines to ensure the safety of patients who participate in clinical trials.
About Atlantic Health System
Atlantic Health System is at the forefront of medicine, setting standards for quality health care in New Jersey, Pennsylvania and the New York metropolitan area. Powered by a workforce of more than 16,800 team members and 4,800 affiliated physicians dedicated to building healthier communities, Atlantic Health System serves more than half of the state of New Jersey including 11 counties and 4.9 million people. The system offers more than 400 sites of care, including six hospitals in New Jersey: Morristown Medical Center and Goryeb Children’s Hospital in Morristown, Overlook Medical Center in Summit, Newton Medical Center in Newton, Chilton Medical Center in Pompton Plains, and Hackettstown Medical Center in Hackettstown.
In addition to the employed workforce, Atlantic Alliance, a Clinically Integrated Network represents more than 2,500 health care providers throughout northern and central New Jersey. This network includes 1,000 physicians and providers comprising one of the largest multi-specialty practices in New Jersey - Atlantic Medical Group, as well as members of the Atlantic Accountable Care Organization and Optimus Healthcare Partners which work to enhance patient care delivery.
Atlantic Health System provides care for the full continuum of health care needs including 12 urgent care centers, Atlantic Rehabilitation and Atlantic Home Care and Hospice. Facilitating the connection between these services on both land and air is the transportation fleet of Atlantic Mobile Health.
Atlantic Health System leads the Healthcare Transformation Consortium, a partnership of seven regional hospitals and health systems dedicated to improving access and affordability and is a founding member of the PIER Consortium – Partners in Innovation, Education, and Research – a streamlined clinical trial system that will expand access to groundbreaking research across seven health systems in New Jersey.
Atlantic Health System has a medical school affiliation with Thomas Jefferson University and is home to the regional campus of the Sidney Kimmel Medical College at Morristown and Overlook Medical Centers and is the official health care partner of the New York Jets.