NCT03455725

CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial

Randomized Controlled Pivotal Trial of Autologous Bone Marrow Cells Using the CardiAMP Cell Therapy System in Patients With Refractory Angina Pectoris and Chronic Myocardial Ischemia (CardiAMP CMI Trial)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 343 (estimated)
• Sponsor: BioCardia, Inc. · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Prospective, multi-center, 2:1 randomized (Treatment : Sham Control), sham-controlled, double-blinded trial to compare treatment using the CardiAMP cell therapy system to sham treatment Treatment Group: Subjects treated with aBMC using the CardiAMP cell therapy system Sham Control Group: Subjects treated with a Sham Treatment (no introduction of the Helix transendocardial delivery catheter, no administration of aBMC)

Conditions

• Refractory Angina
• Chronic Myocardial Ischemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-06-30
• Primary completion: 2025-02-19
• Completion: 2027-12-01
• First posted: 2018-03-07
• Last updated: 2026-01-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study