CardiAMP™ Cell Therapy for Heart Failure Trial

Heart Failure, Systolic Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02438306
• Other study ID #: BC-14-001
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 2016
• Est. completion date: December 2026

Study information

• Verified date: October 2023
• Source: BioCardia, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Heart failure is a clinical condition in which the output of blood from the heart is insufficient to meet the metabolic demands of the body. In 2015, the American Heart Association, or AHA, report on heart disease statistics estimated that there are 5.7 million Americans over the age of 20 that have heart failure. Heart failure is increasingly prevalent due to the aging population and the increase in major cardiovascular risk factors, including obesity and diabetes.

The AHA also estimates that one in five adults will develop heart failure after the age of

40. During heart failure progression, the heart steadily loses its ability to respond to increased metabolic demand, and mild exercise soon exceeds the heart's ability to maintain adequate output. Towards the end stage of the disease, the heart cannot pump enough blood to meet the body's needs at rest. At this stage, fluids accumulate in the extremities or in the lungs making the patient bedridden and unable to perform the activities of daily living. The long-term prognosis associated with heart failure is approximately 50% mortality at five years following the initial diagnosis.

CardiAMP cell therapy is a comprehensive therapeutic treatment that comprises (i) a point of care cell processing platform and (ii) a biotherapeutic delivery system. CardiAMP cell therapy is the first comprehensive therapeutic treatment utilizing a patient's own cells for the treatment of ischemic heart failure with reduced ejection fraction. In the screening process, the physician extracts a small sample of the patient's bone marrow in an outpatient procedure performed under local anesthesia. The clinic sends the sample to a central diagnostic lab, which tests the sample. For the study treatment, a clinician collects and then prepares the patient's own bone marrow mononuclear cells, or autologous cells, using the CardiAMP point of care cell processing platform, which a cardiologist then delivers into the heart using the Helix biotherapeutic delivery system.

BioCardia intends to submit data obtained from this clinical trial in a Pre-Market Approval Application to the United States Food and Drug Administration

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 125
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic

Intervention

Biological:
• Autologous cell therapy
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.

Other:
• Sham
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.

Locations

Country	Name	City	State
Canada	London Health Sciences Center	London	Ontario
Canada	Ottawa Heart Institute	Ottawa	Ontario
Canada	Unity Health Toronto	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
United States	University of Colorado, Denver	Aurora	Colorado
United States	John Hopkins University School of Medicine - Dept of Cardiology	Baltimore	Maryland
United States	Suburban Hospital	Bethesda	Maryland
United States	Morton Plant Mease Health Care	Clearwater	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	Iowa Heart	Des Moines	Iowa
United States	Henry Ford Hospital	Detroit	Michigan
United States	University of Florida - College of Medicine/ div of Cardiovascular Medicine	Gainesville	Florida
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Division of Cardiovascular Medicine, University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	Stern Cardiovascular Foundation	Memphis	Tennessee
United States	Atlantic Health System	Morristown	New Jersey
United States	New York University School of Medicine	New York	New York
United States	Stanford Medical Center, Stanford Health Care	Palo Alto	California
United States	Mayo Clinic	Phoenix	Arizona
United States	Virginia Commonwealth University (VCU) Medical Center	Richmond	Virginia
United States	Michigan Cardiovascular Institute	Saginaw	Michigan
United States	California Pacific Medical Center	San Francisco	California
United States	Oklahoma Heart	Tulsa	Oklahoma
United States	MedStar Health Research Institute	Washington	District of Columbia
United States	Michigan Heart - St.Joseph Mercy Health System (Trinity Health)	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
BioCardia, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Minnesota Living with Heart Failure Questionnaire (MLHFQ)	Mean change in quality of life score as measured by the MLHFQ at 12 months compared to baseline (superiority, treatment vs sham)	12 months
Secondary	Survival	Overall survival compared between both study arms (non-inferiority, treatment vs sham)	12 Months
Secondary	Time to first Major Adverse Cardiac Events (MACE)	Time to first MACE, defined as the composite of all-cause death, hospitalization for worsening heart failure, nonfatal recurrent myocardial infarction, placement of a left ventricular assist device (LVAD), or heart transplantation (non-inferiority, treatment vs sham)	12 months

External Links

•   Website for the study sponsor