other material
confidence high
sentiment positive
materiality 0.60
BioCardia completes low-dose enrollment in CardiALLO allogeneic MSC HFrEF trial
BioCardia, Inc.
- Enrolled and dosed 3 patients in low-dose cohort (20M cells) of Phase I/II CardiALLO trial.
- Trial is first prospective allogeneic MSC study targeting HFrEF patients with elevated heart stress/inflammation markers.
- DSMB safety review expected March 2025; next dose escalation (100M cells) to follow.
- Used Morph DNA steerable guide for enhancing cell delivery during treatment procedures.
- Program aims to support pivotal US studies and conditional time-limited approval in Japan.