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CardiAMP™ Cell Therapy for Heart Failure Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02438306
Recruitment Status : Active, not recruiting
First Posted : May 8, 2015
Last Update Posted : October 10, 2023
Sponsor:
Information provided by (Responsible Party):
BioCardia, Inc.

Tracking Information
First Submitted Date  ICMJE May 5, 2015
First Posted Date  ICMJE May 8, 2015
Last Update Posted Date October 10, 2023
Actual Study Start Date  ICMJE December 2016
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2020)
A composite endpoint based on a 3-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis. [ Time Frame: 12 Months ]
The tiers include (1) all-cause death, (2) non-fatal MACCE events, and (3) change for 6MWD from baseline to month 12.
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
Change in Six (6) Minute Walk Distance at 12 months from baseline [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2023)
  • Minnesota Living with Heart Failure Questionnaire (MLHFQ) [ Time Frame: 12 months ]
    Mean change in quality of life score as measured by the MLHFQ at 12 months compared to baseline (superiority, treatment vs sham)
  • Survival [ Time Frame: 12 Months ]
    Overall survival compared between both study arms (non-inferiority, treatment vs sham)
  • Time to first Major Adverse Cardiac Events (MACE) [ Time Frame: 12 months ]
    Time to first MACE, defined as the composite of all-cause death, hospitalization for worsening heart failure, nonfatal recurrent myocardial infarction, placement of a left ventricular assist device (LVAD), or heart transplantation (non-inferiority, treatment vs sham)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
  • Overall survival as a non-inferiority outcome [ Time Frame: 12 months ]
  • Freedom from Major Adverse Cardiac Events (composite of all-cause death,hospitalization for worsening heart failure, nonfatal MI, [LVAD], or heart transplantation) as a non-inferiority outcome [ Time Frame: 12 months ]
  • Change in quality of life as measured by Minnesota Living with Heart Failure questionnaire as a superiority outcome [ Time Frame: 12 months ]
  • Overall survival as a superiority outcome [ Time Frame: 12 months ]
  • Survival at 2 years [ Time Frame: 24 months ]
  • Heart Failure Death [ Time Frame: 12 months ]
  • Treatment-emergent Serious Adverse Event at 30-days [ Time Frame: 1 month ]
  • Heart failure hospitalization [ Time Frame: 12 months ]
  • All-cause hospitalization [ Time Frame: 12 months ]
  • Days alive out of hospital [ Time Frame: 12 months ]
  • Freedom from Serious Adverse Events [ Time Frame: 12 months ]
  • NYHA Functional Class [ Time Frame: 12 months ]
  • Time to first MACE [ Time Frame: 12 months ]
  • 6 MWD repeated measure analysis [ Time Frame: 12 months ]
  • Echocardiographic measures of change in ejection fraction, left ventricular end systolic and end diastolic volumes, left ventricular end systolic and end diastolic dimensions, mitral regurgitation (composite) [ Time Frame: 12 months ]
  • Technical Success defined as 10 successful injections of ABM MNC to the target locations. [ Time Frame: Baseline ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CardiAMP™ Cell Therapy for Heart Failure Trial
Official Title  ICMJE Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients With Ischemic Heart Failure (CardiAMP Heart Failure Trial)
Brief Summary This is a prospective, multi-center, randomized, controlled, patient- and evaluator-blinded study comparing treatment with the CardiAMP cell therapy to a sham control treatment. A roll-in phase with a maximum of 10 subjects may occur.
Detailed Description

Heart failure is a clinical condition in which the output of blood from the heart is insufficient to meet the metabolic demands of the body. In 2015, the American Heart Association, or AHA, report on heart disease statistics estimated that there are 5.7 million Americans over the age of 20 that have heart failure. Heart failure is increasingly prevalent due to the aging population and the increase in major cardiovascular risk factors, including obesity and diabetes.

The AHA also estimates that one in five adults will develop heart failure after the age of 40. During heart failure progression, the heart steadily loses its ability to respond to increased metabolic demand, and mild exercise soon exceeds the heart's ability to maintain adequate output. Towards the end stage of the disease, the heart cannot pump enough blood to meet the body's needs at rest. At this stage, fluids accumulate in the extremities or in the lungs making the patient bedridden and unable to perform the activities of daily living. The long-term prognosis associated with heart failure is approximately 50% mortality at five years following the initial diagnosis.

CardiAMP cell therapy is a comprehensive therapeutic treatment that comprises (i) a point of care cell processing platform and (ii) a biotherapeutic delivery system. CardiAMP cell therapy is the first comprehensive therapeutic treatment utilizing a patient's own cells for the treatment of ischemic heart failure with reduced ejection fraction. In the screening process, the physician extracts a small sample of the patient's bone marrow in an outpatient procedure performed under local anesthesia. The clinic sends the sample to a central diagnostic lab, which tests the sample. For the study treatment, a clinician collects and then prepares the patient's own bone marrow mononuclear cells, or autologous cells, using the CardiAMP point of care cell processing platform, which a cardiologist then delivers into the heart using the Helix biotherapeutic delivery system.

BioCardia intends to submit data obtained from this clinical trial in a Pre-Market Approval Application to the United States Food and Drug Administration

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure, Systolic
Intervention  ICMJE
  • Biological: Autologous cell therapy
    Autologous cell therapy delivered into the heart muscle using the CardiAMP Cell Therapy System. The CardiAMP Cell Therapy System consists of the CardiAMP Cell Separator, a cardiac delivery catheter, and flexible tip guide catheter.
  • Other: Sham
    An introducer guidewire is placed into the heart and left ventriculography is performed just like it is in the Experimental Arm but no autologous cell therapy is delivered.
Study Arms  ICMJE
  • Experimental: CardiAMP cell therapy
    Placement of an introducer guidewire, performance of a left ventriculogram, and treatment with autologous cell therapy.
    Intervention: Biological: Autologous cell therapy
  • Sham Comparator: Sham Comparator
    Placement of an introducer guidewire and performance of a left ventriculogram with no autologous cell therapy treatment.
    Intervention: Other: Sham
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 5, 2023)
125
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2015)
250
Estimated Study Completion Date  ICMJE December 2026
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • New York Heart Association (NYHA) Class II or III
  • A diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as defined by selected criteria.
  • 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.
  • Left ventricular ejection fraction between 20% and 40%.
  • Qualification of a pre-procedure screening of the patient's bone-marrow characteristics

Exclusion Criteria:

• Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02438306
Other Study ID Numbers  ICMJE BC-14-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party BioCardia, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE BioCardia, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carl Pepine, MD University of Florida
Principal Investigator: Amish Raval, MD University of Wisconsin, Madison
Principal Investigator: Duncan Stewart, MD Ottawa Heart Institute Research Corporation
PRS Account BioCardia, Inc.
Verification Date October 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP