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Could your own bone marrow repair a failing heart?

NCT ID NCT06258447

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a patient's own bone marrow cells, processed and delivered to the heart via a catheter, can improve outcomes for people with chronic ischemic heart failure. About 250 participants with moderate-to-severe heart failure will either receive the cell treatment or a sham procedure. The goal is to see if the treatment reduces deaths, hospitalizations, and improves quality of life.

What this could mean

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

Active substance
patient's own bone marrow cells (autologous bone marrow mononuclear cells)
What this could lead to
If it works, this could offer a new way to improve heart function and reduce hospitalizations for people with chronic heart failure.
What could go wrong
This is a mid-stage trial with 250 participants, so results are not yet proven. The procedure involves bone marrow aspiration and heart catheterization, which carry risks like bleeding or infection.
Why investors are watching

BioCardia is running a 250-patient randomized trial of its CardiAMP cell therapy for people with ischemic heart failure. The trial compares the therapy to a sham procedure with diagnostic catheterization, and both patients and evaluators are blinded. For a micro-cap company, this readout is the main event: a positive result could validate the product, while a negative one would leave the company without a clear path forward.

If it works: If the trial shows the therapy is safe and effective, BioCardia could have a marketable treatment for a large patient population. That result would give the company a foundation to seek regulatory approval and build a commercial business.

If it fails: Trials often fail, and a negative or unclear result would likely undermine the company's prospects. A delay in the readout would also hurt, since the company's value depends heavily on this single study.

AI-written from the trial record. Speculative, and not investment advice.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Apr 2029

An estimate. End dates often move.

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 * 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.

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

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

Ischemic heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cleveland Clinic

    WITHDRAWN

    Cleveland, Ohio, 44195, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Henry Ford Hospital

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Morton Plant Hospital - BayCare

    RECRUITING

    Clearwater, Florida, 33756, United States

  • University of Wisconsin-Division of Cardiovascular Medicine

    RECRUITING

    Madison, Wisconsin, 53792, United States

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