BioCardia, Inc. (BCDA) announced Tuesday that the Food and Drug Administration has approved its Phase III clinical trial of its CardiAMP autologous cell therapy to treat patients with ischemic heart failure.
The developer of cellular and cell-derived therapeutics to treat cardiovascular and pulmonary diseases said the regulator has approved its proposed CardiAMP Heart Failure II study protocol.
CardiAMP Cell Therapy uses a patient’s own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response.
According to the company, the CardiAMP Heart Failure II Trial builds on positive clinical experience with this autologous cell therapy in almost 200 patients and has potential to provide the primary evidence to support FDA approval and marketing registration.
The currently ongoing CardiAMP Heart Failure trial has completed enrollment and it is anticipated that the final data analyses will be reported in the fourth quarter of fiscal 2024.
The proposed CardiAMP Heart Failure II study includes an eligibility requirement that patients demonstrate a pre-specified NT-proBNP level at baseline. The proposed primary efficacy endpoint is also modified from that in the currently ongoing study.
The trial is supported by the Maryland Stem Cell Research Fund and the Centers for Medicare and Medicaid Services.
Peter Altman, BioCardia’s President and Chief Executive Officer, said, “CardiAMP Heart Failure II has strong support from our clinical investigators who have reviewed the interim trial results in detail and have first-hand knowledge of this great unmet clinical need. We expect that we can perform this study efficiently at world class clinical centers based on the extensive experience of the ongoing trial and its positive clinical outcomes.”
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