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Lab-Grown heart cells implanted in 10 patients in bid to repair damaged hearts

NCT ID NCT04945018

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This early-phase trial is testing whether heart muscle cells grown from stem cells can be safely injected into the hearts of 10 people with severe heart failure caused by blocked arteries. The main goal is to check for side effects over 26 weeks, while also measuring whether the treatment improves the heart's pumping ability. If successful, it could lead to larger studies exploring a new repair strategy for failing hearts.

What this could mean

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

Active substance
iPS cell-derived heart muscle cells (HS-001)
What this could lead to
If it works, this could point toward a new way to repair damaged heart muscle in people with severe heart failure, potentially reducing the need for a heart transplant.
What could go wrong
This is a very early, small trial with only 10 participants, so results may not apply to everyone. There are risks from the injection procedure and the cells themselves, such as irregular heartbeats or rejection.

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 10 people

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

Started

Apr 2022

Expected to finish

Jan 2026

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 either screening cardiac MRI or echocardiographic assessment * New York Heart Association (NYHA) cardiac function classification of grade II or higher at screening * Other Criteria apply, please contact the investigator Exclusion Criteria: * Patients screened less than 1 month after the onset of myocardial infarction * Patients with congenital heart disease, or cardiac sarcoidosis * Other Criteria apply, please contact the investigator

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Conditions

The condition(s) this trial relates to.

heart failure myocardial ischemia

As listed by the trial registrant

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

Heart failure Ischemic heart disease

Contacts and locations

Locations

  • Juntendo University Hospital

    Tokyo, Japan

  • Nihon University Itabashi Hospital

    Tokyo, Japan

  • Saitama Medical University International Medical Center

    Saitama, Japan

  • St. Marianna University Hospital

    Kawasaki, Japan

  • The University of Tokyo Hospital

    Tokyo, Japan

  • Tokyo Medical and Dental University Medical Hospital

    Tokyo, Japan

  • Tokyo Metropolitan Geriatric Medical Center

    Tokyo, Japan

  • Tokyo Women's Medical University

    Tokyo, Japan

More trials for these conditions

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