BioCardia Announces Pause in Enrollment for Phase III CardiAMP Cell Therapy Heart Failure Trial
SUNNYVALE, Calif., July 24, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for cardiovascular and pulmonary disease treatment, has received a recommendation from the independent Data Safety Monitoring Board (DSMB) to temporarily pause new enrollment in its ongoing Phase III pivotal CardiAMP® Cell Therapy Heart Failure Trial. This trial, which has been granted Breakthrough Designation by the FDA, aims to evaluate the efficacy of CardiAMP® Cell Therapy in treating heart failure patients (clinicaltrials.gov Identifier: NCT02438306).
The DSMB conducted a prespecified data review and concluded that additional blinded data needs to be collected before proceeding with new enrollments. As a result, BioCardia will temporarily halt the trial until one-year follow-up outcomes analysis can be conducted for both treated patients and those who have been enrolled but not yet treated.