CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial

NARecruitingINTERVENTIONAL
Enrollment

343

Participants

Timeline

Start Date

June 30, 2021

Primary Completion Date

July 31, 2025

Study Completion Date

December 31, 2026

Conditions
Refractory AnginaChronic Myocardial Ischemia
Interventions
DEVICE

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.

OTHER

Sham Treatment

Patients will receive sham bone marrow procedure and a ventriculogram. A scripted sham percutaneous procedure will be performed

Trial Locations (2)

32610

RECRUITING

University of Florida, Gainesville

53792

RECRUITING

University of Wisconsin Madison, Madison

Sponsors

Lead Sponsor

All Listed Sponsors
lead

BioCardia, Inc.

INDUSTRY