BioCardia announced the enrollment of the first patient in their Phase 3 CardiAMP HF II clinical trial, which is evaluating their lead cell therapy for heart failure.
This trial will assess the safety and effectiveness of the autologous cell therapy, which uses a patient’s own bone marrow cells delivered to the heart to potentially stimulate healing.
The study builds on previous trials and is designed to confirm prior positive results in patients with a specific type of heart failure and elevated stress markers.
Advances in this trial include personalized dosing and improvements to the delivery system, with BioCardia planning regulatory submissions for both the therapy and delivery platform based on existing data.
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