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

Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients With Ischemic Heart Failure II Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Heart Failure
• Intervention / Treatment: Device: Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Debby Holmes-Higgin, MS, MPH; Phone Number: 650-226-0120; Email: debbyhh@biocardia.com

Study Locations

• United States
  • Florida
    • Clearwater, Florida, United States, 33756
      • Recruiting
      • Morton Plant Hospital - BayCare
      • Contact: Delia Johnson, RN; Email: Delia.Johnson@baycare.org
      • Principal Investigator: Leslie Miller, MD
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University
      • Contact: Tanveer Kauser Clinical Coordinator; Email: tanveer.kauser@emory.edu
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Hospital
      • Contact: Melanee Schimmel Clinical Coordinator; Email: MSchimm2@hfhs.org
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Withdrawn
      • Cleveland Clinic
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • University of Wisconsin-Division of Cardiovascular Medicine
      • Contact: Besa Jonuzi; Email: bjonuzi@wisc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Device: Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system; 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.
Sham Comparator: Control Treatment; Left ventricular (diagnostic) catheterization but no administration of ABM MNC	Device: Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Efficacy Endpoint	The primary efficacy endpoint is the comparison of a composite score based on a 3-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis. The tiers, starting with the most serious events, would be (1) all cause death, including cardiac death equivalents such as heart transplant or left ventricular assist device placement, ordered by time to event; (2) non-fatal MACCE events (heart failure hospitalization or a worsening heart failure, stroke or MI) ordered by time to event, excluding those deemed procedure related occurring within the first 7 days, and (3) change for quality of life as measured using the Minnesota Living with Heart Failure Questionnaire (MLwHFQ)	Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First Secondary Endpoint	Time to all-cause death, LVAD/heart transplant, or heart failure hospitalization	Baseline through study completion, maximum of two years
Second Secondary Endpoint	Cumulative heart failure hospitalizations	Baseline through study completion, maximum of two years
Third Secondary Endpoint	Time to first heart failure hospitalization	Baseline through study completion, maximum of two years
Sixth Secondary Endpoint	Change in functional capacity as measured using the 6-minute walk test (6MWT)	Baseline to 12 months, 24 months
Seventh Secondary Endpoint	Modified Primary Efficacy Endpoint consisting of all-cause death, LVAD/heart transplant, heart failure hospitalizations and worsening heart failure events treated as an outpatient but without a quality-of-life measure	Baseline through study completion, maximum of two years
Fourth Secondary Endpoint	Change in quality of life as measured using the MLwHF questionnaire based on a scale of 0-105, with 0 being best.	Baseline to 12 months, 24 months
Fifth Secondary Endpoint	Change in quality of life as measured using the Kansas City Cardiomyopathy questionnaire (KCCQ), based on a scale of 0-100, with 100 being best	Baseline to 12 months, 24 months

Collaborators and Investigators

• Sponsor: BioCardia, Inc.
• Investigators: Principal Investigator: Amish Raval, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Heart Failure; Ischemia
• Other Study ID Numbers: 05804 (CLIN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan at this time to make IPD available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No