The company’s investigational therapy uses a patient’s bone marrow cells to trigger the body’s natural ability to heal itself, according to BioCardia. These data are the first to be published from any pivotal trial of a stem cell therapy for heart failure, the company noted.
The first cohort of patients from the 260-patient CardiAmp-HF trial saw improvements in their six-minute walk distance and 40% of patients improved by one class in the New York Heart Association Heart Failure Class scoring system.
The trial is designed to support a marketing application for the investigational therapy. Preliminary results of the trial are scheduled to be published in the journal Circulation Research in September.
“Delivery on the promise of regenerative therapy will require the development of novel strategies leveraging knowledge gained in prior trials to prospectively identify patients likely to respond to therapy to optimize therapeutic potency through evidence-based cell characterization, preparation, and delivery. CardiAMP-HF is a first step in this direction. We believe that trials offering more specific, patient-centered and ‘personalized’ approaches to regenerative medicine will generate the robust and effective therapies needed to address CHF (congestive heart failure) and other conditions,” the paper’s authors wrote.