CardiAMP™ Cell Therapy for Heart Failure Trial

NCT02438306 | Completed Phase 3 DMC

• 1 other identifier: BC-14-001
• Study Type: interventional
• Target: 125
• Locations: 2 countries
• Sites: 24

Brief Summary

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.

Conditions

Heart Failure, Systolic

Outcome Measures

Primary Outcomes (1)

• A composite endpoint based on a 3-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis.

  The tiers include (1) all-cause death, (2) non-fatal MACCE events, and (3) change for 6MWD from baseline to month 12.

  12 Months

Secondary Outcomes (3)

• Minnesota Living with Heart Failure Questionnaire (MLHFQ)

  12 months

• Survival

  12 Months

• Time to first Major Adverse Cardiac Events (MACE)

  12 months

Study Arms (2)

CardiAMP cell therapy

EXPERIMENTAL

Placement of an introducer guidewire, performance of a left ventriculogram, and treatment with autologous cell therapy.

Biological: Autologous cell therapy

Sham Comparator

SHAM COMPARATOR

Placement of an introducer guidewire and performance of a left ventriculogram with no autologous cell therapy treatment.

Other: Sham

Interventions

Autologous cell therapy BIOLOGICAL

Autologous cell therapy delivered into the heart muscle using the CardiAMP Cell Therapy System. The CardiAMP Cell Therapy System consists of the CardiAMP Cell Separator, a cardiac delivery catheter, and flexible tip guide catheter.

CardiAMP cell therapy

Sham OTHER

An introducer guidewire is placed into the heart and left ventriculography is performed just like it is in the Experimental Arm but no autologous cell therapy is delivered.

Sham Comparator

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• New York Heart Association (NYHA) Class II or III
• A diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as defined by selected criteria.
• On stable evidence-based medical and device therapy for ischemic etiology heart failure, per the ACC/AHA Heart Failure guidelines, for at least three (3) months prior to randomization.
• Left ventricular ejection fraction between 20% and 40%.
• Qualification of a pre-procedure screening of the patient's bone-marrow characteristics

You may not qualify if:

• Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.

Sponsors & Collaborators

• BioCardia, Inc.: lead

Study Sites (24)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Stanford Medical Center, Stanford Health Care

Palo Alto, California, 94305, United States

Location

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

University of Colorado, Denver

Aurora, Colorado, 80045, United States

Location

Morton Plant Mease Health Care

Clearwater, Florida, 33756, United States

Location

University of Florida - College of Medicine/ div of Cardiovascular Medicine

Gainesville, Florida, 32606, United States

Location

Iowa Heart

Des Moines, Iowa, 50266, United States

Location

John Hopkins University School of Medicine - Dept of Cardiology

Baltimore, Maryland, 21287, United States

Location

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Michigan Cardiovascular Institute

Saginaw, Michigan, 48601, United States

Location

Michigan Heart - St.Joseph Mercy Health System (Trinity Health)

Ypsilanti, Michigan, 48197, United States

Location

Atlantic Health System

Morristown, New Jersey, 07960, United States

Location

New York University School of Medicine

New York, New York, 10010, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Oklahoma Heart

Tulsa, Oklahoma, 74104, United States

Location

Stern Cardiovascular Foundation

Memphis, Tennessee, 38103, United States

Location

Virginia Commonwealth University (VCU) Medical Center

Richmond, Virginia, 23298, United States

Location

Division of Cardiovascular Medicine, University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792-0001, United States

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

London Health Sciences Center

London, Ontario, Canada

Location

Ottawa Heart Institute

Ottawa, Ontario, KIY 4W7, Canada

Location

Unity Health Toronto

Toronto, Ontario, Canada

Location

Related Publications (2)

• Raval AN, Johnston PV, Duckers HJ, Cook TD, Traverse JH, Altman PA, Dhingra R, Hematti P, Borrello I, Anderson RD, Pepine CJ. Point of care, bone marrow mononuclear cell therapy in ischemic heart failure patients personalized for cell potency: 12-month feasibility results from CardiAMP heart failure roll-in cohort. Int J Cardiol. 2021 Mar 1;326:131-138. doi: 10.1016/j.ijcard.2020.10.043. Epub 2020 Oct 20.

  PMID: 33091520 DERIVED

• Raval AN, Cook TD, Duckers HJ, Johnston PV, Traverse JH, Abraham WT, Altman PA, Pepine CJ. The CardiAMP Heart Failure trial: A randomized controlled pivotal trial of high-dose autologous bone marrow mononuclear cells using the CardiAMP cell therapy system in patients with post-myocardial infarction heart failure: Trial rationale and study design. Am Heart J. 2018 Jul;201:141-148. doi: 10.1016/j.ahj.2018.03.016. Epub 2018 Apr 3.

  PMID: 29803986 DERIVED

Related Links

• Website for the study sponsor

MeSH Terms

Conditions

Heart Failure, Systolic

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Carl Pepine, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

• Amish Raval, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Duncan Stewart, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2015
• First Posted: May 8, 2015
• Study Start: December 1, 2016
• Primary Completion: February 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (20); CA (4)