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Heart Failure, SystolicPhase 3NCT02438306

CardiAMP™ Cell Therapy for Heart Failure Trial

A Phase 3 study testing Autologous cell therapy in people with Heart Failure, Systolic, run by BioCardia, Inc. at 24 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 90 years
Conditions the study is for
Heart Failure, Systolic
What is being tested?
Autologous cell therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
125 participants
Where
24 sitesin 2 countries
Study dates
Dec 2016to Jun 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

24 sites in 2 countries.

24 sites in 2 countries

United States20 sites

  • University of Colorado, Denver

    Aurora, Colorado, 80045

  • John Hopkins University School of Medicine - Dept of Cardiology

    Baltimore, Maryland, 21287

  • Suburban Hospital

    Bethesda, Maryland, 20814

  • Morton Plant Mease Health Care

    Clearwater, Florida, 33756

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Iowa Heart

    Des Moines, Iowa, 50266

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • University of Florida - College of Medicine/ div of Cardiovascular Medicine

    Gainesville, Florida, 32606

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Division of Cardiovascular Medicine, University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792-0001

  • Stern Cardiovascular Foundation

    Memphis, Tennessee, 38103

  • Atlantic Health System

    Morristown, New Jersey, 07960

  • New York University School of Medicine

    New York, New York, 10010

  • Stanford Medical Center, Stanford Health Care

    Palo Alto, California, 94305

  • Mayo Clinic

    Phoenix, Arizona, 85054

  • Virginia Commonwealth University (VCU) Medical Center

    Richmond, Virginia, 23298

  • Michigan Cardiovascular Institute

    Saginaw, Michigan, 48601

  • California Pacific Medical Center

    San Francisco, California, 94115

  • Oklahoma Heart

    Tulsa, Oklahoma, 74104

  • Michigan Heart - St.Joseph Mercy Health System (Trinity Health)

    Ypsilanti, Michigan, 48197

Other trials in United States

Canada4 sites

  • London Health Sciences Center

    London, Ontario

  • Ottawa Heart Institute

    Ottawa, Ontario, KIY 4W7

  • Unity Health Toronto

    Toronto, Ontario

  • St. Paul's Hospital

    Vancouver, British Columbia

Other trials in Canada

About this study

Official title: 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)

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.

Read the 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

Being tested
Autologous cell therapy, Sham
Medical subject headings
Heart Failure, Systolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous cell therapyBiological

    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.

  • ShamOther

    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 groups in NCT02438306
Study groupRoleWhat they receive
CardiAMP cell therapyExperimentalPlacement of an introducer guidewire, performance of a left ventriculogram, and treatment with autologous cell therapy.
Receives: Biological: Autologous cell therapy
Sham ComparatorSham comparatorPlacement of an introducer guidewire and performance of a left ventriculogram with no autologous cell therapy treatment.
Receives: Other: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A composite endpoint based on a 3-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis.

    The tiers include (1) all-cause death, (2) non-fatal MACCE events, and (3) change for 6MWD from baseline to month 12.

    Measured: 12 Months

Secondary outcomes (3)

  1. Minnesota Living with Heart Failure Questionnaire (MLHFQ)

    Mean change in quality of life score as measured by the MLHFQ at 12 months compared to baseline (superiority, treatment vs sham)

    Measured: 12 months

  2. Survival

    Overall survival compared between both study arms (non-inferiority, treatment vs sham)

    Measured: 12 Months

  3. Time to first Major Adverse Cardiac Events (MACE)

    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)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2015 (estimated)
  2. Study startDec 2016
  3. Primary completionFeb 2025
  4. Study completionJun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02438306
Sponsor's protocol ID
BC-14-001
Status last verified
Sep 2025
First submitted
5 May 2015
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Raval AN, Johnston PV, Duckers HJ, Cook TD, Traverse JH, Altman PA, Dhingra R, Hematti P, Borrello I, Anderson RD, Pepine CJ. Point of care, bone marrow mononuclear cell therapy in ischemic heart failure patients personalized for cell potency: 12-month feasibility results from CardiAMP heart failure roll-in cohort. Int J Cardiol. 2021 Mar 1;326:131-138. doi: 10.1016/j.ijcard.2020.10.043. Epub 2020 Oct 20.

    PubMed 33091520

  • Raval AN, Cook TD, Duckers HJ, Johnston PV, Traverse JH, Abraham WT, Altman PA, Pepine CJ. The CardiAMP Heart Failure trial: A randomized controlled pivotal trial of high-dose autologous bone marrow mononuclear cells using the CardiAMP cell therapy system in patients with post-myocardial infarction heart failure: Trial rationale and study design. Am Heart J. 2018 Jul;201:141-148. doi: 10.1016/j.ahj.2018.03.016. Epub 2018 Apr 3.

    PubMed 29803986

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Autologous cell therapy in people with Heart Failure, Systolic, run by BioCardia, Inc. at 24 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A composite endpoint based on a 3-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis. (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02438306, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.

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