Stem Cell Heart Patch During Bypass Surgery for Ischemic Heart Failure
Tests a stem cell patch placed during bypass surgery in ischemic heart failure.
Plain-language title generated from the registry record
Registry title: hiPSC-CMs-loaded Chitosan Patch to Treat Severe Chronic Ischemic Heart Disease
Key facts
- Where
- Changsha, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07471698, who can take part
Where in China
- The Second Xiangya Hospital of Central South UniversityChangsha, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- HELP Therapeutics Co., Ltd.
- Trial code
- NCT07471698
- Record updated
- 13 March 2026
- Original description
This is an exploratory study. A total of 16 patients meeting the inclusion and exclusion criteria and awaiting coronary artery bypass grafting (CABG) surgery will be enrolled. After providing informed consent, participants will be randomized 1:1 under double-blind conditions into two groups:Read full original descriptionShow less
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Human Induce Pluripotent Stem Cell-derived Cardiomyocytes(HiCM-188) -Loaded Chitosan Patch to Treat Severe Chronic Ischemic Heart Disease
This is an exploratory study. A total of 16 patients meeting the inclusion and exclusion criteria and awaiting coronary artery bypass grafting (CABG) surgery will be enrolled. After providing informed consent, participants will be randomized 1:1 under double-blind conditions into two groups:
1. CABG + HiCM-188-loaded chitosan patch group (patch size: 2×4 cm; containing 5 million cells per patch) 2. CABG + blank chitosan patch group (identical in appearance but without HiCM-188 cells).
During CABG surgery, investigators will apply two HiCM-188-loaded chitosan patches onto the epicardial surface over regions of hypokinetic myocardium. The total transplanted cell dose per patient in the treatment group is 1 × 10⁷ . In the control group, eight patients will undergo identical surgical procedures with application of chitosan patches without HiCM-188 cells.
Inclusion: Age between 18 and 80 years (inclusive); Willingness and ability to give written informed consent; Chronic left ventricular dysfunction classified as Stage D (refractory end-stage heart failure) according to ACC staging criteria; NYHA functional class III-IV despite optimized guideline-directed medical therapy for heart failure; Indication for coronary artery bypass grafting (CABG), meeting one of the following anatomical criteria:; 5.1 Class I Indications :; Left ventricular dysfunction with significant left main coronary artery disease; Left ventricular dysfunction with "left main equivalent" disease (i.e., ≥70% stenosis in proximal LAD or proximal LCx); 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; 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); Echocardiographic evidence of regional wall motion abnormalities (hypokinesis, akinesis, or presence of ventricular aneurysm).
Exclusion: Severe valvular heart disease or prior prosthetic valve replacement; Prior percutaneous coronary intervention (PCI) with stent implantation; Long-term systemic immunosuppressive therapy (e.g., corticosteroids, TNF-α inhibitors); History of permanent pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device implantation; History of sustained ventricular tachycardia or aborted sudden cardiac death; Severe contrast media allergy (anaphylactic or life-threatening reaction history); Known hypersensitivity to penicillin or streptomycin; Contraindication to undergoing cardiac MRI (e.g., incompatible implanted devices, severe claustrophobia unresponsive to premedication); History of solid organ or bone marrow transplantation; Active malignancy or history of cancer within the past 5 years (except non-melanoma skin cancer or carcinoma in situ); Life expectancy <1 year due to non-cardiac conditions; Contraindications to immunosuppressive therapy (e.g., active infection, uncontrolled diabetes, peptic ulcer disease); Active infectious diseases: HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis (Treponema pallidum, TP); Baseline estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m²; Coagulation disorder (INR >1.5 without therapeutic anticoagulation, platelets <50×10⁹/L, or clinically significant bleeding diathesis); Patients meeting any of the following criteria are ineligible for study participation:; Chronic atrial fibrillation; Hematocrit <25%; Currently participating in another interventional clinical trial; Pregnant or lactating women.