CardiAMP Cell Therapy Heart Failure Trial to be Featured in Two Presentations at Heart Failure Society of America Annual Meeting 2021
SAN CARLOS, Calif., Sept. 10, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a company focused on developing cellular and cell derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces data from its CardiAMP® Cell Therapy Heart Failure pivotal trial (ClinicalTrials.gov Identifier: NCT02438306), which are being presented at the Heart Failure Society of America Annual Meeting 2021 on Saturday, September 11. This year’s meeting provides a hybrid format; in-person at the Gaylord Rockies in Denver, Colorado or global live on-line access.
Dr. Natasha Altman, principal investigator at the University of Colorado at Denver, will make a trial design presentation titled, “CardiAMP Cell Therapy Heart Failure Trial Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells.” She will provide an overview of the trial, along with her site’s experience to date.
Dr. Leslie Miller, principal investigator at the Congestive Heart Failure Heart Function Clinic in Clearwater, Florida, will make a presentation titled, “Women with Heart Failure in the CardiAMP Cell Therapy Trial.” As seen historically in heart failure studies, female participants are underrepresented in this study. The preliminary clinical data demonstrate women may be more likely than men to meet the cell potency assay study eligibility criterion due to the nature of their cells. Although concentration of CD34+ cells at baseline screening in patients’ bone marow did not differ significantly between males and females, females tended to meet the cell potency assay criterion at a higher rate than males (83% vs 67%); age did not appear to confound results.
“It is great news that women meet the criteria for the CardiAMP cell potency assay at a higher rate than do men, which may result in more physicians recommending the investigational therapy to their female patients who, unfortunately, have consistently been underrepresented in rigorous heart failure trials -- including the CardiAMP Cell Therapy trial,” said Dr. Sujith Shetty, BioCardia’s Chief Medical Officer. “Through our data presentation we have already shared more about autologous cell therapy patient to patient variation than has appeared in the literature from any other trial, and this trial has already enrolled more US patients than all but three previous US trials.”
Forward Looking Statements:
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