Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING NA

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

NCT06258447 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • DEVICE Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system

Study Locations (5)

Florida

  • Morton Plant Hospital - BayCare — Clearwater

Georgia

  • Emory University — Atlanta

Michigan

  • Henry Ford Hospital — Detroit

Ohio

  • Cleveland Clinic — Cleveland

Wisconsin

  • University of Wisconsin-Division of Cardiovascular Medicine — Madison

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2024-08-01
Est. Completion 2029-04-01
Phase NA

Sponsor

BioCardia

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06258447

The ClinicalTrials.gov registry entry for NCT06258447 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioCardia, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Ischemic Heart Failure appearing as the primary indexed condition, and to 1 intervention — of which Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06258447 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Florida, Georgia, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06258447 about?

NCT06258447 is a clinical study titled "CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction". 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...

What is the current status of trial NCT06258447?

This trial is currently recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2024-08-01. Estimated completion is 2029-04-01.

What conditions does trial NCT06258447 study?

This clinical trial studies the following conditions: Ischemic Heart Failure. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06258447?

The interventions under investigation include: Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06258447?

This trial is sponsored by BioCardia, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06258447 being conducted?

This trial has 5 study locations across Florida, Georgia, Michigan, Ohio, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial