NEW YORK – BioCardia on Monday said it has paused enrollment in a Phase III trial of its heart failure stem cell therapy based on a data safety monitoring board (DSMB) recommendation.
Sunnyvale, California-based BioCardia in 2016 launched the pivotal trial to study CardiAMP, an investigational therapy that comprises autologous bone marrow cells and is designed to stimulate healing in the heart. The cells are delivered through a minimally invasive, catheter-based procedure.
The board recommended pausing the trial after reviewing interim data on 111 patients randomized to either the CardiAMP or a control arm. As part of the prespecified data analysis plan, the board considered the treatment's impact on a composite endpoint, with metrics including survival and major adverse cardiac events. After reviewing unblinded data, however, the board concluded that the trial was unlikely to meet that endpoint.
The independent DSMB recommended that the company pause enrolling new patients and crossover patient procedures until a one-year outcomes analysis for currently enrolled patients is available. The board recommended that, in the interim, investigators remain blinded as to whether patients are in the treatment or control group.
In addition to this heart failure trial, BioCardia is also studying CardiAMP in chronic myocardial ischemia and an NK1R-positive allogeneic cell therapy, called CardiALLO, in heart failure. "We will utilize this pause to accelerate our CardiAMP Chronic Myocardial Ischemia trial and our CardiALLO Heart Failure trial with our world-class clinical partners," BioCardia CEO Peter Altman said in a statement.