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Could your own bone marrow repair a failing heart?

NCT ID NCT02438306

Disease control Sponsor: BioCardia, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether a patient's own bone marrow cells, processed and delivered into the heart muscle, could help people with chronic heart failure. 125 participants were randomly assigned to receive either the cell therapy or a sham procedure. The main goal was to see if the treatment improved survival, reduced heart events, and increased walking distance after one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
autologous bone marrow cells
What this could lead to
If it works, this could offer a new treatment option for people with chronic heart failure, potentially improving survival and daily function.
What could go wrong
This is a completed Phase 3 trial with 125 participants, but results are not yet widely available. The treatment involves a heart procedure, which carries risks like infection or heart damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

125 people

The number who actually took part.

Started

Dec 2016

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

systolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure, systolic

Contacts and locations

Locations

  • Atlantic Health System

    Morristown, New Jersey, 07960, United States

  • California Pacific Medical Center

    San Francisco, California, 94115, United States

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

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

    Madison, Wisconsin, 53792-0001, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Iowa Heart

    Des Moines, Iowa, 50266, United States

  • John Hopkins University School of Medicine - Dept of Cardiology

    Baltimore, Maryland, 21287, United States

  • London Health Sciences Center

    London, Ontario, Canada

  • Mayo Clinic

    Phoenix, Arizona, 85054, United States

  • Michigan Cardiovascular Institute

    Saginaw, Michigan, 48601, United States

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

    Ypsilanti, Michigan, 48197, United States

  • Morton Plant Mease Health Care

    Clearwater, Florida, 33756, United States

  • New York University School of Medicine

    New York, New York, 10010, United States

  • Oklahoma Heart

    Tulsa, Oklahoma, 74104, United States

  • Ottawa Heart Institute

    Ottawa, Ontario, KIY 4W7, Canada

  • St. Paul's Hospital

    Vancouver, British Columbia, Canada

  • Stanford Medical Center, Stanford Health Care

    Palo Alto, California, 94305, United States

  • Stern Cardiovascular Foundation

    Memphis, Tennessee, 38103, United States

  • Suburban Hospital

    Bethesda, Maryland, 20814, United States

  • Unity Health Toronto

    Toronto, Ontario, Canada

  • University of Colorado, Denver

    Aurora, Colorado, 80045, United States

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

    Gainesville, Florida, 32606, United States

  • Virginia Commonwealth University (VCU) Medical Center

    Richmond, Virginia, 23298, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.