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Could a child's own stem cells strengthen a weak heart after surgery?

NCT ID NCT02781922

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether injecting a child's own heart stem cells (JRM-001) after reconstructive surgery can improve heart function in children with single ventricle heart defects. About 40 children scheduled for Glenn or Fontan surgery will receive either the stem cells or a placebo. The main goal is to see if the treatment boosts the heart's pumping ability, measured by MRI.

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

About 40 people

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

Start date

Jun 2016

Expected to finish

Dec 2028

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

0 to 6 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: * Functional single ventricle patient with heart failure who is scheduled for stage 2 (Glenn) or stage 3 (Fontan) surgery * EF(%) by echocardiography ≤ 55% * Able to obtain written informed consent of participation in the study by a parent of the patient Exclusion Criteria: * Known medical history of cardiogenic shock * Lethal, uncontrollable arrhythmia * Complication of coronary artery disease * Eisenmenger syndrome * Complication of brain dysfunction due to circulatory failure * Malignant neoplasm * Complication of severe neurologic disorder * Severe pulmonary embolism or pulmonary hypertension * Severe renal failure * Multiple organ failure * Active infection (including endocarditis) * Sepsis * Active hemorrhagic disease (e.g. gastrointestinal bleeding, injury) * Known history of hypersensitivity to anti-infective drugs * Inability to complete the protocol treatment and baseline to follow-up examinations

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Conditions

The condition(s) this trial relates to.

congenital heart disease hypoplastic left heart syndrome univentricular heart

As listed by the trial registrant

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

Hypoplastic left heart syndrome Single-ventricle

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 places running it

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

  3. The official record

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

    Open the record ↗

  4. 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: •••••@•••••

Locations

  • Kanagawa Children's Medical Center

    RECRUITING

    Kanagawa, Japan

  • Okayama University Hospital

    RECRUITING

    Okayama, Japan

  • Saitama Prefectural Children's Medical Center

    RECRUITING

    Saitama, Japan

  • Shizuoka Children's Hospital

    RECRUITING

    Shizuoka, Japan

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