What this study is
Concentrated autologous bone marrow mononuclear cells (ABM MNC) contain potentially therapeutic cell factors and past studies support therapeutic benefit to patients with cardiac diseases of acute myocardial infarction, ischemia, and heart failure when utilized as this study is designed. The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy system in patients with ischemic heart failure. It is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP cell therapy system to a control procedure with diagnostic catheterization.
What's being tested
- Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system
Intervention · DEVICE
the ABM MNC is obtained from the study patient via bone marrow aspiration in the hip and processed and delivered using the CardiAMP cell therapy system during the cardiac catheterization.
Study details
- Official title
- Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients With Ischemic Heart Failure II Trial
- Sponsor
- BioCardia, Inc.
- Conditions
- Ischemic Heart Failure
- Enrolling
- 250 people
- Starts
- 2024-08-01
- Est. completion
- 2029-04-01
- Design
- Quadruple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years – 90 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- New York Heart Association (NYHA) Class II or III
- Diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as described in the study protocol.
- Left ventricular ejection fraction >20% and <40%
- 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.
- NTproBNP level of >500 pg/ml
- Autologous cell analysis score consistent with study selection assessment
You can't join if
- Selected study criteria as defined in the study protocol indicating that patient is not an optimal candidate for cardiac catheterization or intramyocardial delivery of autologous bone marrow mononuclear cells.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (5)
4 openMorton Plant Hospital - BayCare
Clearwater, Florida, United States
- Delia Johnson, RN · ContactDelia.Johnson@baycare.org
- Leslie Miller, MD · Principal investigator
RecruitingEmory University
Atlanta, Georgia, United States
- Tanveer Kauser Clinical Coordinator · Contacttanveer.kauser@emory.edu
RecruitingHenry Ford Hospital
Detroit, Michigan, United States
- Melanee Schimmel Clinical Coordinator · ContactMSchimm2@hfhs.org
RecruitingUniversity of Wisconsin-Division of Cardiovascular Medicine
Madison, Wisconsin, United States
- Besa Jonuzi · Contactbjonuzi@wisc.edu
RecruitingCleveland Clinic
Cleveland, Ohio, United States
Withdrawn
Study team
Sponsor
BioCardia, Inc.
Study ID 05804 (CLIN)
Principal investigator
Amish Raval, MD
University of Wisconsin, Madison
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.