NEW YORK – BioCardia said this week that the US Food and Drug Administration approved a protocol amendment to its Phase III CardiAMP Heart Failure II clinical trial.
CardiAMP is an autologous cell therapy candidate being studied as a treatment for ischemic heart failure with reduced ejection fraction. Sunnyvale, California-based BioCardia began enrolling participants into the confirmatory, randomized-controlled trial last month.
The amendment aims to increase the number of patients eligible for the trial. Patients who would have been excluded from treatment may now receive additional CardiAMP cell therapy deliveries to reach the same target minimum dosage, utilizing a treatment plan informed by the preprocedural CardiAMP Cell Population Analysis.
The company developed that analysis as a way to select patients most likely to respond to CardiAMP therapy, based on their individual cell compositions at screening.
Data obtained during the study enabled BioCardia to refine its algorithm behind that analysis and develop personalized treatment plans for participants who fall below that initial acceptance criteria. As part of those personalized plans, researchers may adjust the number of dosing aliquots given to patients with lower concentrations of relevant cells.
"This is a substantial advance in autologous cell therapy built on the analysis of clinical data from the 125 patients enrolled in our CardiAMP Heart Failure I Trial," Debby Holmes-Higgin, VP of Clinical at BioCardia, said in a statement. "This modification is expected to enable the same dosing result to be achieved for more patients and enhance the ease, efficiency, and experience for patients, physicians, and coordinators in the CardiAMP Heart Failure II Trial."