Clinical trial NCT02438306: CardiAMP™ Cell Therapy for Heart Failure 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Heart Failure, Systolic
Lead sponsor: BioCardia, Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-08
Enrollment: 125
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: A composite endpoint based on a 3-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis.
timeFrame: 12 Months
Secondary outcomes:
measure: Minnesota Living with Heart Failure Questionnaire (MLHFQ)
timeFrame: 12 months
measure: Survival
timeFrame: 12 Months
measure: Time to first Major Adverse Cardiac Events (MACE)
timeFrame: 12 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford Medical Center, Stanford Health Care
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado, Denver
state: Colorado
city: Washington
country: United States
facility: MedStar Health Research Institute
state: District of Columbia
city: Clearwater
country: United States
facility: Morton Plant Mease Health Care
state: Florida
city: Gainesville
country: United States
facility: University of Florida - College of Medicine/ div of Cardiovascular Medicine
state: Florida
city: Des Moines
country: United States
facility: Iowa Heart
state: Iowa
city: Baltimore
country: United States
facility: John Hopkins University School of Medicine - Dept of Cardiology
state: Maryland
city: Bethesda
country: United States
facility: Suburban Hospital
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Saginaw
country: United States
facility: Michigan Cardiovascular Institute
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart - St.Joseph Mercy Health System (Trinity Health)
state: Michigan
city: Morristown
country: United States
facility: Atlantic Health System
state: New Jersey
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Heart
state: Oklahoma
city: Memphis
country: United States
facility: Stern Cardiovascular Foundation
state: Tennessee
city: Richmond
country: United States
facility: Virginia Commonwealth University (VCU) Medical Center
state: Virginia
city: Madison
country: United States
facility: Division of Cardiovascular Medicine, University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: Unity Health Toronto
state: Ontario
Study officials:
affiliation: University of Florida
name: Carl Pepine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Amish Raval, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Heart Institute Research Corporation
name: Duncan Stewart, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.