BioCardia has reported late-breaking echocardiography results from its phase III clinical trial of its cell-based therapy for the treatment of ischaemic heart failure of reduced ejection fraction (HFrEF).
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 results were presented by Amish Raval (University of Wisconsin School of Medicine and Public Health, Madison, USA), CardiAMP HF trial national co-principal investigator, at the 2026 Technology and Heart Failure Therapeutics (THT) conference (2–4 March, Boston, USA).
Raval reported that patients receiving the autologous CardiAMP cell therapy under investigation demonstrated positive evidence of decreased pathological left ventricular remodelling over time compared to patients not receiving the treatment.
The results correlated to findings for the trial primary and key secondary endpoints of reduced fatal and non-fatal major adverse cardiovascular events and improved quality of life measures for treated patients.
Echocardiography outcomes were measured by the blinded echo cardiography core laboratory at the Yale University Cardiovascular Research Group. The Yale core laboratory measured both left ventricular end diastolic volume, when the heart ventricle is fully dilated (p=0.06), and left ventricular end systolic volume, when the heart is fully contracted (p=0.09).
For the prespecified subgroup of patients having elevated biomarkers of heart stress, the differences between the treated and control patients were both clinically meaningful (>20ml/m2 and 15 ml/m2, respectively) and statistically significant (p=0.02 and p=0.01, respectively).
“In patients with baseline elevated NTproBNP levels, a biomarker of myocardial stress, CardiAMP treatment is associated with less adverse cardiac remodelling according to core-lab measured left ventricular volumes,” said Wilson Tang (Cleveland Clinic, Cleveland, USA), a member of the executive steering committee for the CardiAMP HF trials.
“The burden of heart failure continues to grow, cardiac ischaemia dominates the cause, and the impact of current pharmaceuticals remains limited,” said Carl Pepine (University of Florida, Gainesville, USA), co-national principal investigator for the CardiAMP HF trial. “Today’s results from the CardiAMP-HF cell therapy trial are promising and show the potential of optimally targeting subgroups for treatment.”
