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CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction

BioCardia, Inc. · NCT06258447

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 21–90 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
250
US sites recruiting
4
Study start
August 1, 2024
Record last updated
February 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system

Conditions: Ischemic Heart Failure

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Recruiting US locations

  • Morton Plant Hospital - BayCare

    Clearwater, FL 33756

    Site contact: Delia Johnson, RN · Delia.Johnson@baycare.org

  • Emory University

    Atlanta, GA 30322

    Site contact: Tanveer Kauser Clinical Coordinator · tanveer.kauser@emory.edu

  • Henry Ford Hospital

    Detroit, MI 48202

    Site contact: Melanee Schimmel Clinical Coordinator · MSchimm2@hfhs.org

  • University of Wisconsin-Division of Cardiovascular Medicine

    Madison, WI 53792

    Site contact: Besa Jonuzi · bjonuzi@wisc.edu

Study contacts (from the official record)

  • Debby Holmes-Higgin, MS, MPH · 650-226-0120 · debbyhh@biocardia.com
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CardiAMP Heart Failure II Trial for Patients With Ischemic Heart… (NCT06258447) | Bored Studies