BioCardia has reported positive results from a Phase I/II trial of adult mesenchymal stem cells (MSCs) delivered using its Helical Infusion system for the treatment of ischemic heart failure.
The CE-marked proprietary system, which includes the Helical Infusion system catheter and Morph vascular access catheter, delivers donor’s (allogeneic) or treated patient’s (autologous) MSCs via transendocardial stem cell injection (TESI).
The study found that treatment with allogeneic or autologous MSCs produced similar results, although fewer ventricular arrhythmias were reported in patients receiving allogeneic treatment.
University of Miami Miller School of Medicine Interdisciplinary Stem Cell Institute director and study lead principal investigator Dr Joshua Hare said; "The combination of Allogenic MSCs with the BioCardia Helix catheter has enormous potential as a combination product for treating heart failure."
The study, which enrolled 31 patients with chronic ischemic left ventricular dysfunction due to ischemic cardiomyopathy, were randomised 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 hospitalised for a minimum of four days and were seen two weeks post-catheterisation.
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.
BioCardia president and CEO Peter Altman said; "The Helical Infusion system is intended to be the safest and easiest to use catheter for multiple clinical applications in cell and gene-based therapy."
The system is also under investigation in a total of four biotherapeutic programmes to treat heart failure in the US, according to the company.