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NCT06258447

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

Recruiting now NA Last updated 9 February 2026
What this trial tests

NA trial testing Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system in Ischemic Heart Failure in 250 participants. Currently enrolling.

Timeline
1 August 2024
Primary endpoint
1 April 2027
1 April 2029

Quick facts

Lead sponsorBioCardia, Inc.
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment250
Start date1 August 2024
Primary completion1 April 2027
Estimated completion1 April 2029
Sites5 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

BioCardia, Inc. — full company profile →

Who can join

Adults 21 to 90, any sex, with Ischemic Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Stem cell therapy for patients with acute myocardial infarction: a systematic review of clinical trials.
    Mahram H, Khalafi V, Arman A, Mirhosseini SA, et al · · 2025 · PMID 41469916 · DOI 10.1186/s13287-025-04882-6

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Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06258447.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing