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Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells
Sponsor: BioCardia, Inc.
Summary
This clinical study will utilize allogenic bone marrow-derived culture-expanded MSC that are expanded from mesenchymal stem cells and delivered using the investigational Helix transendocardial delivery catheter as a therapy for ischemic HFrEF with reduced ejection fraction.
Official title: Phase I/II Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells (hMSCs) in Patients With Ischemic Heart Failure With Reduced Ejection Fraction (HFrEF)
Key Details
Gender
All
Age Range
21 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
39
Start Date
2023-08-23
Completion Date
2027-12
Last Updated
2025-12-12
Healthy Volunteers
No
Conditions
Interventions
CardiALLO™ Human Allogenic Culture-expanded Bone marrow-derived Mesenchymal Stem Cells (hMSCs)
CardiALLO™ Human Allogenic Culture-expanded Bone marrow-derived Mesenchymal Stem Cells (hMSCs) delivered with the Helix transendocardial delivery catheter (treatment)
Diagnostic Catheterization
Left ventricular catheterization with no active therapy
Locations (1)
University of Florida
Gainesville, Florida, United States