Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CardiALLO · 1 trial · 1 indication
Incidence of TE-SAE defined as a composite of death, non-fatal MI, stroke, worsening HF (requiring admission, iv diuretics and/or inotropics), myocardial perforation (with tamponade), ventricular arrythmias \>15 seconds
The primary efficacy endpoint is a composite endpoint based on a 3-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis. The tiers, starting with the most serious events, would be (1) all cause death, including cardiac death equivalents such as heart transplant or left ventricular assist device placement, ordered by time to event; (2) non-fatal MACCE events excluding those deemed procedure related occurring within the first 7 days (heart failure hospitalization, stroke or MI) ordered by time to event, and (3) change for 6MWD.
| Arm | Type | Description |
|---|---|---|
| Study Treatment | ACTIVE_COMPARATOR | Phase I of the study will utilize a dose escalation study design with three patients at 20 million MSCs, three patients at 100 million MSC, and three patients at 200 million MSC to identify dose for Phase II. The study treatment (active comparator) is comprised of left ventricular catheterization and treatment with allogeneic hMSC using the Helix transendocardial delivery catheter. |
| Control | SHAM_COMPARATOR | In Phase II of the study, the control group will undergo left ventricular catheterization with introduction of an iliofemoral sheath but no introduction of the Helix transendocardial delivery catheter but no administration of allogeneic hMSC with the Helix transendocardial delivery catheter. |
| Name | Type | Description |
|---|---|---|
| CardiALLO™ Human Allogenic Culture-expanded Bone marrow-derived Mesenchymal Stem Cells (hMSCs) | COMBINATION_PRODUCT | CardiALLO™ Human Allogenic Culture-expanded Bone marrow-derived Mesenchymal Stem Cells (hMSCs) delivered with the Helix transendocardial delivery catheter (treatment) |
| Diagnostic Catheterization | DIAGNOSTIC_TEST | Left ventricular catheterization with no active therapy |
Inclusion Criteria: * New York Heart Association (NYHA) Class II or III * Diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction * Left ventricular ejection fraction between 20% and 40% * On stable, guideline-directed medical and device therapy, as appropriate...
CardiALLO is an investigational cell therapy being developed by BioCardia, Inc. for systolic heart failure. It consists of human allogeneic culture-expanded bone marrow-derived mesenchymal stem cells (hMSCs). It is currently in Phase 1 clinical development and has not been approved by the FDA.
CardiALLO is being studied for the treatment of systolic heart failure. The ongoing Phase 1 trial enrolls patients with this condition. It is an investigational therapy and is not approved for any indication.
CardiALLO is being developed by BioCardia, Inc., a company whose common stock trades on the Nasdaq under the ticker symbol BCDA. BioCardia is the sponsor of the clinical program evaluating this allogeneic mesenchymal stem cell therapy.
CardiALLO is in Phase 1 clinical development. The program includes one active trial that is currently not recruiting. No Phase 2 or Phase 3 trials have been initiated, and the therapy remains investigational.
CardiALLO is being evaluated in a single Phase 1 trial, NCT05925608, titled Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells. The trial is active but not recruiting, has an enrollment of 39 participants, and is conducted in the United States.