BioCardia Announces First Patient Treated in CardiAMP Cell Therapy Trial for Chronic Myocardial Ischemia

October 21, 2021—BioCardia, Inc. a company focused on developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced the treatment of the first patient in its phase III pivotal CardiAMP CMI trial.

The study is evaluating BioCardia’s investigational CardiAMP autologous cell therapy for patients with no-option chronic myocardial ischemia (CMI) with refractory angina. These patients experience frequent angina attacks that are uncontrolled by optimal drug therapy but are not suitable candidates for stent placement or bypass surgery, leaving them with no therapeutic options, noted the company.

The first patient in the study was treated at the University of Wisconsin in Madison, Wisconsin, by interventional cardiologist and Associate Professor of Medicine Amish Raval, MD, supported by Peiman Hematti, MD, bone marrow transplantation hematologist and Professor of Medicine.

According to BioCardia, the CardiAMP CMI trial is expected to enroll up to 343 patients at up to 40 centers. The primary endpoint will evaluate improvement in exercise tolerance at 6 months after the study procedure. The trial is intended to have an adaptive statistical analysis plan with an initial assessment for efficacy when 100 patients reach their primary endpoint, although aspects of the statistical analysis plan remain the subject of study considerations with the FDA.

The Conational Principal Investigators for the trial are Thomas Povsic, MD, with Duke University in Durham, North Carolina, and Timothy Henry, MD, with The Christ Hospital in Cincinnati, Ohio.

In addition to Drs. Povsic and Henry, the executive steering committee for this pivotal study includes Dr. Raval; Carl Pepine, MD, with the University of Florida in Gainesville, Florida; and Bernard J. Gersh, MBChB, with the Mayo School of Medicine in Rochester, Minnesota. Drs. Raval and Pepine are Conational Principal Investigators for the ongoing CardiAMP Cell Therapy Heart Failure trial that paved the way for the new CMI trial, noted the company.

BioCardia stated that CardiAMP cell therapy uses a patient’s autologous bone marrow cells delivered to the heart in a catheter-based procedure to potentially stimulate the body’s natural healing response. The therapy incorporates a preprocedural screening assay to identify those patients who are likely responders to the therapy. Patients eligible to undergo the cell therapy procedure receive cells delivered with a system that has been shown in published literature to present the lowest risk to patients for biotherapeutic delivery and to be three to six times more efficient at delivering cells to the heart muscle than other methods. This approach allows the patient to be discharged from the hospital the morning after the study procedure.

The company noted that earlier in 2021, the FDA approved a detailed protocol amendment to shorten the trial’s primary endpoint to a 6-month follow-up from 1 year and to harmonize details of the protocol to correspond with the actively enrolling CardiAMP Cell Therapy Heart Failure trial, which has incorporated best practices from significant interactions with study centers and FDA. Both trials have a Category B designation from FDA and the Centers for Medicare and Medicaid Services (CMS), enabling study sites to receive CMS reimbursement for both the standard-of-care procedures and the investigational CardiAMP cell therapy system.