Cardiovascular regenerative medicine specialist BioCardia®, Inc., tells us that the first patient was treated in the RECARDIO clinical trial studying the safety and preliminary efficacy of endocavitary intramyocardial injection of autologous bone marrow-derived CD133+ cells as delivered by the company’s Helix™ Transendocardial Delivery System in patients with ischemic refractory cardiomyopathy.
BioCardia develops regenerative biologic therapies to treat cardiovascular disease. The Company’s current products include the Helix™ Transendocardial Delivery System and the Morph® steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix Systems and clinical support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction., sponsored by Centro Cardiologico Monzino.
RECARDIO is a multi-center trial at three sites, Centro Cardiologico Monzino in Milan, Italy, Azienda Ospedaliera Città della Salute e della Scienza di Torino in Torino, Italy, and Azienda Ospedaliera San Gerardo di Monza in Monza, Italy.
The primary endpoint of safety will be evaluated up to one year after enrollment. Secondary endpoints will be assessed before treatment and at six months post-treatment on a) regional myocardial perfusion on the basis of stress gated-SPECT and CMR, when available and b) functional capacity on the basis of peak VO2 consumption at CPET.
“We are honored to work with Dr. Guilio Pompilio as principal investigator for the RECARDIO Trial, and we look forward to positive safety and efficacy results from the trial,” said Peter Altman, Chief Executive Officer for BioCardia.
Source: BioCardia, Inc.