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) (CardiAMP-CMI)

NCT03455725 NA ACTIVE_NOT_RECRUITING

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)

Details

Lead sponsor	BioCardia, Inc.
Phase	NA
Status	ACTIVE_NOT_RECRUITING
Enrolment	343
Start date	2021-06-30
Completion	2027-12

Conditions

• Refractory Angina
• Chronic Myocardial Ischemia

Interventions

• CardiAMP Cell Therapy System
• Sham Treatment

Primary outcomes

• Change from Baseline in Total Exercise Time on the treadmill using the Modified Bruce Protocol — Baseline and 6 months visit
  A superiority analysis with regards to change from Baseline in Total Exercise Time at the 6 months follow-up visit (using a Modified Bruce Protocol).

Countries

United States