Stem cell patch aims to mend broken hearts in landmark trial
NCT ID NCT07471698
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Cabg-patients are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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.
- New scan could help decide who benefits from heart surgery
- Rehab program shows promise in tracking blood flow recovery
- Stem cell injection during bypass surgery aims to repair damaged hearts
- Heart failure patients get RNA boost during bypass in first human test
- Could your own bone marrow repair a failing heart?
- Lab-grown heart cells injected into failing hearts: a new hope?