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Lab-grown heart cells injected into failing hearts: a new hope?

NCT ID NCT07347197

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This early-phase trial will test whether injecting lab-grown heart muscle cells (made from stem cells) into the heart can safely help people with severe heart failure. Fourteen participants with weak hearts will receive the cells via a catheter. The main goal is to check for side effects over 26 weeks, while also measuring whether heart function improves.

What this could mean

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

Active substance
Human iPS-cell-derived cardiomyocyte spheroids (HS-001CS) injected into the heart
What this could lead to
If it works, this could point toward a new way to repair damaged heart muscle and improve heart function in people with severe heart failure.
What could go wrong
This is an early, small trial (14 people) testing safety first. The cells may not survive or integrate, and there are risks from the injection procedure and potential immune reactions.

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 14 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jan 2030

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

20 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: * Patients with resting left ventricular ejection fraction (LVEF) ≦40% based on institutional assessment on screening echocardiographic assessment * New York Heart Association (NYHA) cardiac function classification of grade II or III at screening * Other Criteria apply, please contact the investigator Exclusion Criteria: * Patients with cardiac devices such as pacemakers, implantable cardioverter defibrillators (ICDs), or cardiac resuscitation-enabled implantable cardioverter defibrillators (CRT-Ds) * Patients with heart failure due to the primary disease hypertrophic cardiomyopathy (including the dilated phase), restrictive cardiomyopathy, amyloidosis, takotsubo cardiomyopathy, congenital heart disease, cardiac sarcoidosis, or constrictive pericarditis * Other Criteria apply, please contact the investigator

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Conditions

The condition(s) this trial relates to.

dilated cardiomyopathy heart failure myocardial ischemia systolic heart failure

As listed by the trial registrant

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

Dilated cardiomyopathy (DCM) Heart failure Ischemic heart disease Ischemic heart failure

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  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

Study contacts

  • Contact

    Email: •••••@•••••

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