BioCardia has announced the initiation of its CardiAMP heart failure pivotal trial—a randomised, controlled, multicentre study of up to 260 patients evaluating CardiAMP cell therapy at up to 40 clinical sites in the USA. The trial has been initiated at two centres: Johns Hopkins University (under the leadership of Peter Johnston and Gary Gerstenblith) and the University of Florida at Gainesville, (under the leadership of David Anderson and Carl Pepine).
A press release reports that the CardiAMP therapy for heart failure integrates a biomarker panel, a cell processing system for autologous bone marrow-derived cells, and a unique transendocardial delivery system. This therapy will be reviewed under the PMA regulations by the FDA’s Center for Biologics Evaluation and Research (CBER) division. More information is available at www.clinicaltrials.gov, trial identifier: NCT02438306.
Eric Duckers, BioCardia chief medical officer, says: “We are honoured to be working with the leading clinical research teams at each of these important centres to advance a therapeutic strategy that has great promise to help patients suffering from heart failure developed after a heart attack.”