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Stem cell shot during bypass aims to rebuild failing hearts

NCT ID NCT07496372

Disease control Sponsor: HELP Therapeutics Co., Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether injecting lab-grown heart muscle cells (HiCM-188) into the heart during bypass surgery can help people with severe heart failure (NYHA class III-IV). Eighty participants will receive either the stem cells plus bypass or bypass alone. The main goal is to see if they can walk farther in 6 minutes, with other measures including survival and heart function.

What this could mean

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

Active substance
human induced pluripotent stem cell-derived cardiomyocytes (HiCM-188)
What this could lead to
If it works, this could offer a new way to repair damaged heart muscle in people with severe heart failure, potentially improving their ability to walk and reducing hospitalizations.
What could go wrong
This is an early Phase 3 trial with only 80 participants, so results may not apply to everyone. Stem cell therapies carry risks like immune reactions or arrhythmias, and the long-term effects are still unknown.

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 80 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Aug 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

18 to 75 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: 1. Aged 18 to 75 years, regardless of gender; 2. Patients with ischemic heart failure with NYHA functional class III or IV after receiving the maximum tolerated dose of guideline-directed medical therapy (GDMT); 3. LVEF ≤ 35% as measured by cardiac MRI; 4. Coronary angiography meeting the indications for coronary artery bypass grafting (CABG) surgery; 5. Voluntary participation and signing of the informed consent form. Exclusion Criteria: Patients considered for this trial must not meet any of the following criteria: 1. Acute viral myocarditis; 2. Acute phase of myocardial infarction (≤ 3 months); 3. Cardiac amyloidosis; 4. Pericarditis; 5. Expected to undergo heart transplantation; 6. Suffering from a disease that restricts the motor system, making them unable to complete the 6-minute walk test; 7. Suffering from autoimmune diseases; 8. Estimated glomerular filtration rate (eGFR) \< 35 ml/min/1.73m², or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 100 U/L; 9. Presence of any untreated precancerous lesions or those requiring active monitoring; 10. Occurrence of malignant tumors within 5 years prior to screening; 11. Expected to undergo other concurrent cardiac surgeries (excluding ventricular aneurysm resection and left atrial appendage excision/ligation); 12. Having contraindications to the use of immunosuppressants; 13. Having contraindications to MRI; 14. Having contraindications to CABG surgery; 15. Females who are pregnant, lactating, or have a positive blood pregnancy test; 16. Plans to conceive within one year; 17. Having systemic diseases that are not effectively controlled; 18. Other conditions deemed unsuitable for participation in this clinical trial as evaluated by the investigator.

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Conditions

The condition(s) this trial relates to.

advanced heart failure heart failure

As listed by the trial registrant

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

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

    1 site. 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

  • TEDA International Cardiovascular Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300457, China

More trials for these conditions

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