Date: 2014-05-07
Type of information: Treatment of the first patient
phase: 1
Announcement: treatment of the first patient
Company: Centro Cardiologico Monzino (Italy) BioCardia (USA - CA)
Product: autologous bone marrow-derived CD133+ cells
Action
mechanism: cell therapy
Disease: ischemic refractory cardiomyopathy
Therapeutic area: Cardiovascular diseases
Country: Italy
Trial
details: The RECARDIO Trial 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 purpose of this study is to evaluate whether endocavitary intramyocardial injection of autologous bone-marrow-derived CD133+ cells is safe on the basis of number of adverse events, with follow-up assessments extending up to 1 year after enrolment. 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. (NCT02059681)
Latest
news: * On May 7, 2014, BioCardia, a leader in cardiovascular regenerative medicine, today announced that the first patient was treated in the RECARDIO clinical trial, sponsored by Centro Cardiologico Monzino. The RECARDIO Trial is 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.
