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Stem cell patch aims to mend broken hearts in landmark trial

NCT ID NCT07471698

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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-stage trial tests whether a patch loaded with lab-grown heart muscle cells can help repair damaged heart tissue. Sixteen people with severe heart failure who are already scheduled for bypass surgery will receive either the stem cell patch or a blank patch during their operation. The main goals are to check safety and see if the patch improves 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) loaded onto a chitosan patch
What this could lead to
If it works, this could point toward a way to repair damaged heart muscle and improve heart function in people with severe heart failure.
What could go wrong
This is a very early, small study (16 people) focused on safety. The stem cell patch may not improve heart function, and there are risks like abnormal heart rhythms or tumor formation.

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 16 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 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

18 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: 1. Age between 18 and 80 years (inclusive). 2. Willingness and ability to give written informed consent. 3. Chronic left ventricular dysfunction classified as Stage D (refractory end-stage heart failure) according to ACC staging criteria. 4. NYHA functional class III-IV despite optimized guideline-directed medical therapy for heart failure. 5. Indication for coronary artery bypass grafting (CABG), meeting one of the following anatomical criteria: 5.1 Class I Indications : 1. Left ventricular dysfunction with significant left main coronary artery disease; 2. Left ventricular dysfunction with "left main equivalent" disease (i.e., ≥70% stenosis in proximal LAD or proximal LCx); 3. Left ventricular dysfunction with two- or three-vessel disease including proximal LAD stenosis. 5.2 Class IIa Indication : Left ventricular dysfunction with substantial viable, akinetic but revascularizable myocardium, not covered by above Class I anatomical criteria. 6. Left ventricular ejection fraction (LVEF) ≤40% as measured by echocardiography or cardiac MRI within 6 months prior to enrollment (excluding measurements obtained within 1 month post-myocardial infarction). 7. Echocardiographic evidence of regional wall motion abnormalities (hypokinesis, akinesis, or presence of ventricular aneurysm). Exclusion Criteria: Patients meeting any of the following criteria are ineligible for study participation: 1. History of permanent pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device implantation. 2. Severe valvular heart disease or prior prosthetic valve replacement. 3. Prior percutaneous coronary intervention (PCI) with stent implantation. 4. Chronic atrial fibrillation. 5. History of sustained ventricular tachycardia or aborted sudden cardiac death. 6. Baseline estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m². 7. Hematocrit \<25%. 8. Severe contrast media allergy (anaphylactic or life-threatening reaction history). 9. Coagulation disorder (INR \>1.5 without therapeutic anticoagulation, platelets \<50×10⁹/L, or clinically significant bleeding diathesis). 10. Known hypersensitivity to penicillin or streptomycin. 11. Contraindication to undergoing cardiac MRI (e.g., incompatible implanted devices, severe claustrophobia unresponsive to premedication). 12. History of solid organ or bone marrow transplantation. 13. Active malignancy or history of cancer within the past 5 years (except non-melanoma skin cancer or carcinoma in situ). 14. Life expectancy \<1 year due to non-cardiac conditions. 15. Long-term systemic immunosuppressive therapy (e.g., corticosteroids, TNF-α inhibitors). 16. Contraindications to immunosuppressive therapy (e.g., active infection, uncontrolled diabetes, peptic ulcer disease). 17. Active infectious diseases: HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis (Treponema pallidum, TP). 18. Currently participating in another interventional clinical trial. 19. Pregnant or lactating women.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • The Second Xiangya Hospital of Central South University

    Changsha, China

More trials for these conditions

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