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Heart repair with stem cells: a new hope for chronic heart failure?

NCT ID NCT06340048

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether injecting lab-grown heart muscle cells (HiCM-188) into the heart during bypass surgery can safely help people with severe chronic heart failure. About 36 adults with damaged heart tissue and reduced pumping function will receive the cell injection. The main goal is to check for serious side effects within the first month, while also looking at heart function and tumor risk over a year.

What this could mean

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

Active substance
Allogeneic human pluripotent stem cell-derived cardiomyocytes (HiCM-188)
What this could lead to
If successful, this could lead to a new way to repair damaged heart muscle in people with severe heart failure, potentially improving heart function and quality of life.
What could go wrong
This is an early-phase trial with only 36 participants, so results may not apply to everyone. Risks include serious side effects like arrhythmias, heart attack, or stroke, and it is unknown if the cells will work long-term.

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 36 people

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

Started

Sep 2023

Expected to finish

May 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 years and older

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. Age ≥18 years 2. Willingness and ability to give written informed consent 3. Nuclide-myocardial metabolic perfusion imaging or Magnetic Resonance Imaging (MRI) revealed infarcted myocardium in the left anterior descending branch (LAD) coronary artery supply area 4. LVEF\<50% as assessed by Echocardiography or LVEF≤40% as assessed by MRI 5. Patients have indications for Coronary Artery Bypass Grafting Exclusion Criteria: 1. Presence of a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy device (CRT) 2. Diagnosed with malignancy within 5 years 3. Autoimmune disease 4. Recipients of organ transplant. 5. Patients undergoing other surgical operations (excluding resection of ventricular aneurysm and left atrial appendage excision/occlusion). 6. Severe ventricular arrhythmia 7. Contraindication to CABG surgery 8. Contraindication to cardiac MRI or PET/CT scan. 9. Contraindication to immunosuppressants 10. Participation in another clinical trial within 3 months prior to screening 11. Pregnancy, lactation, or a positive serum pregnancy test 12. Any other condition considered by the investigator to be inappropriate for inclusion in this clinical trial

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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

Contacts and locations

Locations

  • TEDA International Cardiovascular Hospital

    Tianjin, Tianjin Municipality, 300457, China

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