Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Stem cells injected into heart could ease failure

NCT ID NCT05925608

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests if stem cells from donated bone marrow can help people with heart failure. The cells are delivered directly into the heart using a special catheter. The goal is to see if this treatment is safe and can improve heart function, reduce hospital stays, and help patients feel better. The study includes 39 adults with moderate heart failure.

Why investors are watching

BioCardia is running a small Phase I/II trial testing its bone marrow-derived stem cell therapy for people with heart failure and a reduced ejection fraction. The trial uses the company's own delivery catheter to inject the cells into the heart. For a micro-cap company, this readout is a major test of whether its core technology works in patients.

If it works: A positive result could show the therapy improves heart function and validate the delivery catheter, giving BioCardia a stronger case to move into later-stage trials. That could attract partners or funding to keep the program going.

If it fails: The trial is small, with only 39 planned participants, and early-phase studies often fail to show clear benefit. A negative or unclear result could set the program back and put pressure on a company of this size, which depends on this asset.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 39 people

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

Started

Aug 2023

Expected to finish

Dec 2027

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 80 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 * Left ventricular ejection fraction between 20% and 40% * On stable, guideline-directed medical and device therapy, as appropriate * NTproBNP level of \>500 pg/ml. * Have inflammation \> 2 mg/L as measured by high-sensitivity C-reactive protein (hs-CRP) test. Exclusion Criteria: * Other cardiovascular or medical history parameters, as appropriate, that may preclude safe administration of the study treatment.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Heart failure, systolic are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • University of Florida

    Gainesville, Florida, 36210, United States

More trials for these conditions

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