Date: 2014-11-11
Type of information: Submission of a clinical trial application
phase: 3
Announcement: submission of a clinical trial application
Company: BioCardia (USA - CA)
Product: CardiAMP
Action
mechanism: cell therapy. The CardiAMP Therapy for heart failure integrates a proprietary biomarker panel to identify candidates likely to respond to therapy, a cell processing system consisting of a proprietary, high-dosage formulation of autologous bone marrow-derived cells and a transendocardial delivery system that ensures efficient and consistent targeted delivery. This therapy will be reviewed under the PMA regulations by the FDA’s Center for Biologics Evaluation and Research (CBER) division.
Disease: heart failure
Therapeutic area: Cardiovascular diseases
Country:
Trial
details: This is a prospective, multi-center, randomized (3 Treatment : 2 Sham Control), sham-controlled, patient and evaluator-blinded comparing treatment with the CardiAMP System to a sham treatment study. (NCT02438306)
Latest
news: * On November 11, 2014, BioCardia®, a leader in cardiovascular regenerative medicine, announced that the FDA has accepted the Company’s application to begin a Phase III clinical trial of its bone marrow-derived CardiAMP Therapy for heart failure. The clinical trial is a randomized, controlled, multi-center study of 250 patients evaluating CardiAMP Therapy at up to 40 clinical sites. The CardiAMP trial efficacy endpoints include improvements in functional capacity as measured by the Six Minute Walk Test, quality of life as measured by the Minnesota Living with Heart Failure Questionnaire, and survival. Safety endpoints include non-inferiority with respect to survival and freedom from major adverse cardiac events. Co-principal investigators for the trial are Carl Pepine, M.D., and Amish Raval, M.D., who were involved in the trial design. Dr. Pepine is Professor of Medicine, Division of Cardiovascular Medicine, at the University of Florida (UF) and principal investigator for the UF Center for the Cardiovascular Cell Therapy Research Network (CCTRN). He is also past president of the American College of Cardiology (ACC). Dr. Raval is Associate Professor of Medicine, Division of Cardiovascular Medicine, at the University of Wisconsin, where he practices as an interventional cardiologist conducting cardiovascular clinical trials for cell and biologic therapy. He is also Director of Cardiovascular Clinical Research and Director of the Regional ST Elevation Myocardial Infarction Program.
