BioCardia PH III CardiAMP Heart Failure Trial Discussed in American Heart Journal

BioCardia®, Inc., [OTC: BCDA] a leader in cardiovascular regenerative medicine, today announced the publication of the Phase III CardiAMP Heart Failure Trial design paper in the American Heart Journal.

In addition to discussing the trial design, the author of the paper projects the likelihood of meeting primary endpoint. Amish Raval, MD, associate professor of medicine at the  University of Wisconsin School of Medicine  and Public Health and lead author on the paper said, "This paper explains the rationale and methods behind the CardiAMP cell therapy pivotal trial, and points in the direction that there is a greater than 90 percent probability of success in meeting the primary endpoint. If indeed successful, the CardiAMP therapy has great potential to be a cost-effective heart failure treatment provided in a standard interventional cardiology setting."

CardiAMP is a multistep process with the first step being an assay to determine if a biomarker qualifies the patient. If qualified, a small amount of bone marrow (apprx 1 tablespoon) is collected from the patient and processed. Then the patient is infused in a cardiac catheterization lab. The patient is usually discharged the same day or after an overnight stay.

Phase II results relative to patient quality of life and functional capacity, were shown to be both statistically and clinically significant.

The paper points to several novel aspects of this trial. "The use of a Cell Potency Assay (CPA) to select patients who are more likely to yield therapeutic cells, the high effective dose of BM MNCs that will be injected (200 million target dose), and the point of care treatment approach are intended to maximize therapeutic efficacy, limit dose variability and improve treatment efficiency."

In addition, the paper states, "To achieve a high 'effective' cell dose, the CardiAMP study utilizes a helical injection catheter designed to maximize myocardial cell retention. Mitsutake et al. demonstrated acute retention of radiolabeled BM MNC was three-fold higher using the Helix catheter compared to straight needle injections." The Helix delivery system is a proprietary system also developed by BioCardia.

The entry for the clinicaly trial on clinicaltrials.gov estimates that the study completion date to be December of 2020.