Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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, ...
Autologous cell therapy is an investigational treatment being studied for systolic heart failure. It is a cell-based therapy derived from the patient's own cells, developed by BioCardia, Inc. The therapy is currently in Phase 3 clinical development, meaning it is still being tested and is not yet approved for commercial use.
Autologous cell therapy does not target a specific molecular target. Instead, it is a cell-based therapy that uses the patient's own cells to potentially treat systolic heart failure. The exact mechanism of action is not specified, but it is being investigated for its potential to improve heart function in patients with this condition.
Autologous cell therapy is being developed by BioCardia, Inc., a biopharmaceutical company. BioCardia is publicly traded under the ticker symbol BCDA. The company is conducting clinical trials to evaluate the safety and efficacy of this cell therapy for the treatment of systolic heart failure.
Autologous cell therapy is currently in Phase 3 clinical development. This is the final phase of testing before potential regulatory approval. The therapy is being studied for the treatment of systolic heart failure, and it is important to note that it is still investigational and has not been approved by regulatory authorities.
Autologous cell therapy has been studied in one clinical trial, identified by the NCT number NCT02438306. This trial, titled 'CardiAMP™ Cell Therapy for Heart Failure Trial,' was a Phase 3, randomized, double-blind, sham-controlled study that enrolled 125 patients with systolic heart failure. The trial was conducted in the United States and Canada and has been completed.
Autologous cell therapy is the investigational treatment being evaluated in the CardiAMP™ Cell Therapy for Heart Failure Trial. The trial, with NCT number NCT02438306, is a Phase 3 study that has been completed. The therapy is being developed by BioCardia, Inc. for the treatment of systolic heart failure.