BioCardia, Inc. (Nasdaq: BCDA) has achieved a significant milestone in its CardiALLO™ Allogeneic Mesenchymal Cell Therapy program, completing enrollment and dosing in the low-dose cohort of its Phase I/II trial. This pioneering study targets patients with ischemic heart failure of reduced ejection fraction (HFrEF) and represents the first prospective trial of its kind using allogeneic mesenchymal stem cells (MSC) in HFrEF patients with specific biomarker profiles.
Trial Design and Innovation
The CardiALLO Heart Failure Trial follows a structured approach, beginning with an open-label Phase I component involving nine patients in a dose-escalation study. The trial will evaluate three ascending doses: 20 million cells, 100 million cells, and 200 million cells. Following the initial phase, the study will progress to a randomized, double-blinded, placebo-controlled cohort of thirty patients.
Dr. Carl Pepine, Professor of Medicine at the University of Florida Division of Cardiovascular Medicine and National Principal Investigator, emphasized the potential impact: "This novel investigational cell therapy has great potential to help these patients, who suffer from significant lifestyle limitations despite receiving guideline directed medical therapy."
Advanced Delivery Technology
A notable aspect of the trial is the implementation of the FDA-approved Morph DNA steerable guide for therapeutic delivery. Dr. R. David Anderson, Principal Investigator at the University of Florida, noted the enhanced physician control this technology provides during cell delivery procedures.
The proprietary delivery system enables minimally invasive access to the heart through blood vessels, with both the CardiALLO human cells and the catheter delivery system manufactured at BioCardia's Sunnyvale facility.
Scientific Mechanism and Previous Evidence
The "off the shelf" mesenchymal stem cells are theorized to provide dual benefits: immunomodulatory effects in inflammatory disease-mediated heart failure and microvascular repair that enhances capillary density while reducing fibrosis. This approach builds upon BioCardia's previous clinical trials of allogeneic MSC delivery, which demonstrated safety and promising efficacy trends without requiring immunosuppression or causing arrhythmias.
Commercial and Development Outlook
Peter Altman, PhD, BioCardia's President and CEO, highlighted the strategic importance of the program: "Our enhanced manufacturing of these MSC is expected to be commercially scalable. The CardiALLO MSC development is synergistic to our autologous CardiAMP mononuclear cell therapy development."
The company's manufacturing capabilities extend beyond cardiac applications, supporting potential partnerships for other therapeutic areas, including their PulmALLO™ MSC program for acute respiratory distress. This broader application potential comes at a time when the first MSC therapy has recently received FDA approval in the United States.
Safety Monitoring and Next Steps
The trial incorporates a two-week waiting period between dose cohorts, with formal Data Safety Monitoring Board (DSMB) reviews following each dose level. The first DSMB review is anticipated in March 2025, marking a crucial milestone in the therapy's development pathway toward potential pivotal clinical studies in the United States and conditional time-limited approval in Japan.
