Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients With Ischemic Heart Failure (CardiAMP Heart Failure Trial)

NCT02438306 Phase 3 COMPLETED

This is a prospective, multi-center, randomized, controlled, patient- and evaluator-blinded study comparing treatment with the CardiAMP cell therapy to a sham control treatment. A roll-in phase with a maximum of 10 subjects may occur.

Details

Lead sponsor	BioCardia, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	125
Start date	2016-12
Completion	2025-06

Conditions

• Heart Failure, Systolic

Interventions

• Autologous cell therapy
• Sham

Primary outcomes

• A composite endpoint based on a 3-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis. — 12 Months
  The tiers include (1) all-cause death, (2) non-fatal MACCE events, and (3) change for 6MWD from baseline to month 12.

Countries

United States, Canada