BioCardia has announced positive results from a Phase I/II trial of its Helical Infusion system, designed to deliver donor's (allogeneic) or treated patient's (autologous) adult mesenchymal stem cells (MSCs) via transendocardial stem cell injection (TESI).
The CE-marked system, which is a proprietary delivery technology for cell- and gene-based therapy, features Helical Infusion System Catheter and Morph Vascular Access Catheter.
The study, named POSEIDON, has enrolled 31 patients with chronic ischemic left ventricular dysfunction due to ischemic cardiomyopathy to demonstrate the effectiveness of the device in treating heart failure.
Patients were randomized to receive one of three different dose levels (20, 100, or 200 million cells) of either allogeneic MSCs or autologous MSCs via TESI.
Following TESI, patients were hospitalized for a minimum of four days and were seen two weeks post-catheterization.
The results demonstrated that allogeneic and autologous MSCs delivered with the proprietary delivery technology were safe and well-tolerated at all doses.
In addition, the study also showed allogeneic and autologous MSCs yielded similar improvements relative to baseline in the 6-minute walk and the Minnesota Living with Heart Failure Questionnaire.