hiPSC-CMs-loaded Chitosan Patch to Treat Severe Chronic Ischemic Heart Disease (NCT07471698) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
hiPSC-CMs-loaded Chitosan Patch to Treat Severe Chronic Ischemic Heart Disease
China16 participantsStarted 2026-10-20
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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:
✓.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);
Exclusion criteria
✕. History of permanent pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device implantation.
What they're measuring
1
Proportion and frequency of patients experiencing sustained ventricular tachycardia lasting more than 30 seconds
Timeframe: 1~6 Month Post-operation
2
Incidence of allogeneic human-derived tumor formation