Approval Probability
TA Base Rate
Adjusted LOA
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Autologous cell therapy · 1 trial · 1 indication
The tiers include (1) all-cause death, (2) non-fatal MACCE events, and (3) change for 6MWD from baseline to month 12.
| Arm | Type | Description |
|---|---|---|
| CardiAMP cell therapy | EXPERIMENTAL | Placement of an introducer guidewire, performance of a left ventriculogram, and treatment with autologous cell therapy. |
| Sham Comparator | SHAM_COMPARATOR | Placement of an introducer guidewire and performance of a left ventriculogram with no autologous cell therapy treatment. |
| Name | Type | Description |
|---|---|---|
| Autologous cell therapy | BIOLOGICAL | Autologous cell therapy delivered into the heart muscle using the CardiAMP Cell Therapy System. The CardiAMP Cell Therapy System consists of the CardiAMP Cell Separator, a cardiac delivery catheter, and flexible tip guide catheter. |
| Sham | OTHER | An introducer guidewire is placed into the heart and left ventriculography is performed just like it is in the Experimental Arm but no autologous cell therapy is delivered. |
Inclusion Criteria: * New York Heart Association (NYHA) Class II or III * A diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as defined by selected criteria. * On stable evidence-based medical and device therapy for ischemic etiology heart failure, ...
BioCardia's autologous cell therapy is being developed for the treatment of systolic heart failure. It is an investigational cell-based treatment intended for patients with this cardiovascular condition. The therapy has been studied in a Phase 3 clinical trial, but it is not yet approved for commercial use.
BioCardia's autologous cell therapy targets ADA, which is an exogenous gene target. The therapy is designed to deliver this gene target as part of its mechanism of action. ADA is the molecular target specified for this cell therapy candidate.
BioCardia, Inc. is developing this autologous cell therapy. The company trades under the ticker symbol BCDA. BioCardia is responsible for the clinical development of the therapy for systolic heart failure.
BioCardia's autologous cell therapy is in Phase 3 clinical development. The Phase 3 trial has been completed. The therapy is investigational and has not been approved by the FDA for any indication.
BioCardia's autologous cell therapy has been studied in one clinical trial, NCT02438306, titled the CardioAMP Cell Therapy for Heart Failure Trial. This Phase 3 trial enrolled 125 participants, was randomized, double-blind, and sham-controlled, and has been completed. It took place in the United States and Canada.