Clinical trial NCT06258447: CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Heart Failure
Lead sponsor: BioCardia, Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-14
Enrollment: 250
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Controlled study of study treatment consisting of intramyocardial autologous cell injections compared to sham control, both performed in cardiac catheterization
Primary purpose: TREATMENT

Brief 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.

Detailed description: Chronic heart failure is in need of new therapies. Over the past few years, cardiovascular regenerative medicine using bone marrow derived cells has emerged as a new treatment strategy that could have tremendous benefit in treating heart failure and are well supported by recent meta analyses of early clinical data sets. Concentrated autologous bone marrow mononuclear cells (ABM MNC) are the subject of the current study as they are supported by more clinical data than any other cell type described, and contain all of the potentially therapeutic cell factors from studies of selected cells. Study results demonstrate ABM MNC to be safe, and, when delivered intramyocardially as intended in the current study, results consistently support therapeutic benefit to patients with cardiac diseases of acute myocardial infarction, ischemia, and heart failure. 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. The Treatment Group undergoes left ventricular catheterization and is treated with ABM MNC using the CardiAMP cell therapy system. The Control Group has a Control procedure consisting of left ventricular diagnostic catheterization but no introduction of the Helix transendocardial delivery catheter and no administration of ABM MNC.

Eligibility 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.

Primary outcomes:
measure: Primary Efficacy Endpoint
timeFrame: Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months
Secondary outcomes:
measure: First Secondary Endpoint
timeFrame: Baseline through study completion, maximum of two years
measure: Second Secondary Endpoint
timeFrame: Baseline through study completion, maximum of two years
measure: Third Secondary Endpoint
timeFrame: Baseline through study completion, maximum of two years
measure: Fourth Secondary Endpoint
timeFrame: Baseline to 12 months, 24 months
measure: Fifth Secondary Endpoint
timeFrame: Baseline to 12 months, 24 months
measure: Sixth Secondary Endpoint
timeFrame: Baseline to 12 months, 24 months
measure: Seventh Secondary Endpoint
timeFrame: Baseline through study completion, maximum of two years
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Morton Plant Hospital - BayCare
state: Florida
Study officials:
affiliation: University of Wisconsin, Madison
name: Amish Raval, MD
role: PRINCIPAL_INVESTIGATOR
References: