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BioCardia Inc (BCDA)
NASDAQ:BCDA
Cardiallo™ Human Allogenic Culture-Expanded Bone Marrow-Derived Mesenchymal Stem Cells (Hmscs), Diagnostic Catheterization
Heart Failure, Systolic
Phase I/II
Enrolling By Invitation
Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells
Jun 22, 2023
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Sham, Autologous Cell Therapy
Heart Failure, Systolic
Phase III
Completed
CardiAMP™ Cell Therapy for Heart Failure Trial
May 05, 2015
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does BioCardia Inc (BCDA) have in its pipeline
BCDA is currently developing the following drugs: Cardiallo™ Human Allogenic Culture-Expanded Bone Marrow-Derived Mesenchymal Stem Cells (Hmscs), Diagnostic Catheterization, Sham, Autologous Cell Therapy. These drug candidates are in various stages of clinical development as the company works toward FDA approval.