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

Part of paid clinical trials in Clearwater, Florida.

Sponsor
BioCardia, Inc.
Study ID
NCT06258447
Status
Recruiting
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Conditions

  • Ischemic Heart Failure

Eligibility Criteria

Sex
ALL
Age
21 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

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

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.

Key Dates

Start date
Aug 1, 2024
Status verified
Feb 2026
Primary completion
Apr 1, 2027
Completion
Apr 1, 2029

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Study (ABM MNC) Treatment
    Left ventricular catheterization with treatment consisting of autologous bone marrow mononuclear cells (ABM MNC) processed and delivered using the CardiAMP cell therapy system
  • Sham Comparator: Control Treatment
    Left ventricular (diagnostic) catheterization but no administration of ABM MNC

Primary Outcome Measure

Primary Efficacy Endpoint [ Time Frame: Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Morton Plant Hospital - BayCareClearwaterFlorida33756
Delia Johnson, RN
[email protected]
Leslie Miller, MD (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30322
Tanveer Kauser Clinical Coordinator
[email protected]
Henry Ford HospitalDetroitMichigan48202
Melanee Schimmel Clinical Coordinator
[email protected]
Cleveland ClinicClevelandOhio44195-
University of Wisconsin-Division of Cardiovascular MedicineMadisonWisconsin53792

Find similar trials in Clearwater, FL

By research site
Morton Plant Hospital - BayCare· Clearwater, FLEmory University· Atlanta, GAHenry Ford Hospital· Detroit, MICleveland Clinic· Cleveland, OHUniversity of Wisconsin-Division of Cardiovascular Medicine· Madison, WI

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