343
Participants
Start Date
June 30, 2021
Primary Completion Date
July 31, 2025
Study Completion Date
December 31, 2026
CardiAMP Cell Therapy System
The CardiAMP Cell Therapy system consists of the CardiAMP Potency Assay, the Helix/Morph intramyocardial delivery catheter system, and the CardiAMP Cell Separator. The system allows the investigator to identify patients with a high chance to respond to im autologous stem cell therapy (using the CardiAMP Cell Potency Assay), to isolate the stem cells from a bone marrow harvest at the point of care (using the CardiAMP CS system), and to percutaneously inject the autologous cells into the myocardium using the Helix/Morph delivery catheters.
Sham Treatment
Patients will receive sham bone marrow procedure and a ventriculogram. A scripted sham percutaneous procedure will be performed
RECRUITING
University of Florida, Gainesville
RECRUITING
University of Wisconsin Madison, Madison
Lead Sponsor
BioCardia, Inc.
INDUSTRY