First Patient in CardiAMP Device/Cell Combo Therapy Trial for Ischemic Heart Failure February 28, 2017
The first patient has been treated in a pivotal Phase III CardiAMP® clinical trial of a cell-based therapy for the treatment of ischemic heart failure that develops after a heart attack.
Johns Hopkins Medicine, the Maryland Stem Cell Research Fund and BioCardia, Inc. are collaborating to deliver a study that aims to investigate the clinical efficacy of BioCardia’s CardiAMP® regenerative cell therapy in ischemic heart failure patients. The investigational CardiAMP therapy is designed to deliver a high dose of a patient’s own bone marrow cells directly to the point of cardiac dysfunction, potentially stimulating the body’s natural healing mechanism after a heart attack.
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, which includes an optional 10-patient roll-in cohort. The primary endpoint for the trial is a significant improvement in Six Minute Walk distance at 12 months’ post-treatment. Study subjects must be diagnosed with New York Heart Association (NYHA) Class II or III heart failure as a result of a previous heart attack. The national co-principal investigators are Dr. Pepine and Amish Raval, MD, of the University of Wisconsin.
The first patient was treated at Johns Hopkins Hospital by a team led by Peter Johnston, MD, a faculty member in the Department of Medicine and Division of Cardiology, and principal investigator of the trial at Johns Hopkins. The patient experience with CardiAMP therapy begins with a pre-procedural cell potency screening test. If a patient qualifies for therapy, they are scheduled for a bone marrow aspiration. A point of care cell processing platform is then utilized to concentrate the autologous bone marrow cells, which are subsequently delivered in a minimally-invasive procedure directly to the damaged regions in a patient’s heart.
“This cell-based therapy offers great potential for heart failure patients,” said Carl Pepine, MD, professor and former chief of cardiovascular medicine at the University of Florida, Gainesville and national co-principal investigator of the CardiAMP trial. “We look forward to validating the impact of the therapy on patients’ quality of life and functional capacity in this important study.”
“Funding the clinical trial of this cell therapy, which could be the first cardiac cell therapy approved in the United States, is an important step towards treatments,” said Dan Gincel, PhD., executive director of the MSCRF at TEDCO. “Through our clinical program, we are advancing cures and improving healthcare in the State of Maryland.”
Source: Johns Hopkins Medicine, BioCardia, Inc. MSCRF