Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
125 participants
INTERVENTIONAL
2016-12-31
2025-06-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CardiAMP cell therapy
Placement of an introducer guidewire, performance of a left ventriculogram, and treatment with autologous cell therapy.
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.
Sham Comparator
Placement of an introducer guidewire and performance of a left ventriculogram with no autologous cell therapy treatment.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
21 Years
90 Years
ALL
No
Sponsors
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BioCardia, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Carl Pepine, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Amish Raval, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Duncan Stewart, MD
Role: PRINCIPAL_INVESTIGATOR
Ottawa Heart Institute Research Corporation
Locations
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Mayo Clinic
Phoenix, Arizona, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Stanford Medical Center, Stanford Health Care
Palo Alto, California, United States
California Pacific Medical Center
San Francisco, California, United States
University of Colorado, Denver
Aurora, Colorado, United States
Morton Plant Mease Health Care
Clearwater, Florida, United States
University of Florida - College of Medicine/ div of Cardiovascular Medicine
Gainesville, Florida, United States
Iowa Heart
Des Moines, Iowa, United States
John Hopkins University School of Medicine - Dept of Cardiology
Baltimore, Maryland, United States
Suburban Hospital
Bethesda, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Michigan Cardiovascular Institute
Saginaw, Michigan, United States
Michigan Heart - St.Joseph Mercy Health System (Trinity Health)
Ypsilanti, Michigan, United States
Atlantic Health System
Morristown, New Jersey, United States
New York University School of Medicine
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oklahoma Heart
Tulsa, Oklahoma, United States
Stern Cardiovascular Foundation
Memphis, Tennessee, United States
Virginia Commonwealth University (VCU) Medical Center
Richmond, Virginia, United States
Division of Cardiovascular Medicine, University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
St. Paul's Hospital
Vancouver, British Columbia, Canada
London Health Sciences Center
London, Ontario, Canada
Ottawa Heart Institute
Ottawa, Ontario, Canada
Unity Health Toronto
Toronto, Ontario, Canada
Countries
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References
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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.
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.
Related Links
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Website for the study sponsor
Other Identifiers
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BC-14-001
Identifier Type: -
Identifier Source: org_study_id
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