BioCardia, a pioneer in cellular therapeutics, has announced the commencement of patient enrollment for its pivotal Phase 3 trial of the CardiAMP Cell Therapy for the treatment of ischemic heart failure with reduced ejection fraction (HFrEF). This marks a significant milestone in advancing innovative treatments for cardiovascular diseases.
Key Highlights:
- FDA Breakthrough Device Designation: CardiAMP Cell Therapy has been granted a Breakthrough Device Designation by the FDA, underscoring its potential to significantly improve treatment outcomes for patients with ischemic heart failure. This designation enables expedited development and priority review of regulatory submissions, accelerating patient access to this promising therapy.
- Pivotal Phase 3 Trial: The trial, involving 250 patients, is a randomized, controlled study designed to confirm the therapy’s efficacy. The primary composite endpoint includes all-cause death, reduction in major adverse cardiovascular events, and improvement in quality of life over a minimum of 12 months.
- Innovative Treatment Approach: CardiAMP Cell Therapy leverages a patient’s own bone marrow cells, delivered to the heart through a minimally invasive procedure, to potentially stimulate the body’s natural healing response. This approach includes proprietary elements such as pre-procedural cell analysis for patient selection, a high target dosage of cells, and a unique delivery system that enhances cell retention and safety.
- Significant Clinical Needs: Heart failure of reduced ejection fraction affects millions and is expected to increase. Despite existing therapies, many patients progress to advanced heart failure, highlighting the need for new, effective treatments. CardiAMP Cell Therapy aims to address this gap by improving survival rates and quality of life.
- Previous Study Success: Interim results from the earlier CardiAMP Heart Failure I Study showed a 37% relative risk reduction in all-cause death and an 86% relative risk reduction in mortality for patients with active heart failure. The new study builds on these promising results, focusing on those who exhibited the greatest benefits.
- Quality of Life Focus: The primary endpoint of the Phase 3 trial includes a validated quality of life self-assessment, reflecting the therapy’s potential to not only extend life but also enhance living conditions for patients.
Expert Endorsements:
Dr. Leslie Miller, a trial investigator at the CHF Heart Function Clinic at BayCare Morton Plant Hospital, emphasizes the therapy’s transformative potential:
“The CardiAMP cell therapy could be groundbreaking and life-changing for patients with heart failure.” Dr. Miller’s site is actively enrolling patients, with several already meeting key inclusion criteria.
BioCardia’s CEO, Peter Altman, PhD, expresses optimism for the trial: “We look forward to working with world-class clinical teams to confirm the trends observed in previous studies and provide a much-needed treatment option for patients with ischemic heart failure.”
The Future of Heart Failure Treatment
As BioCardia embarks on this critical Phase 3 trial, the medical community and patients alike are hopeful for the successful development of CardiAMP Cell Therapy. This innovative approach promises not only to improve survival rates but also to enhance the quality of life for millions suffering from heart failure.
Stay tuned for updates on the progress of this groundbreaking trial and its implications for the future of cardiovascular treatment. For more information, visit BioCardia.