eClinical Technology and Industy News

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

Excerpt from the Press Release:

SAN CARLOS, Calif., Oct. 21, 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 announced the treatment of the first patient in its Phase III pivotal CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial for patients with no option chronic myocardial ischemia with refractory angina. These patients experience frequent angina (chest pain) 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.

The first patient was treated with the investigational CardiAMP autologous cell therapy at the University of Wisconsin in Madison, by Interventional Cardiologist and Associate Professor of Medicine Amish Raval, M.D., supported by Peiman Hematti, M.D., Bone Marrow Transplantation Hematologist and Professor of Medicine.

The CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial is expected to enroll up to 343 patients at up to 40 centers. The primary endpoint will evaluate improvement in exercise tolerance at six months following 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 co-National Principal Investigators for the trial are Thomas Povsic, M.D. of Duke University, Durham, NC, and Timothy Henry, M.D. of The Christ Hospital, Cincinnati, OH.

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. The therapy incorporates a pre-procedural screening assay to identify those patients who are likely responders to the therapy, a first for a cardiac cell 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 delivery1 and to be three to six times more efficient at delivering cells to the heart muscle than other methods.2 This approach allows the patient to be discharged from the hospital the morning after the study procedure.

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