hiPSC-CMs-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.

NCT Number	NCT07471698
Lead Sponsor	Help Therapeutics Collaborators: Second Xiangya Hospital of Central South University
Conditions	Ischemic Heart Failure, CABG-patients
Enrollment	16 participants
Start Date	2026-10-20
Primary Completion	2028-10-20 (estimated)
Study Completion	2028-10-20 (estimated)
Updated on ClinicalTrials.gov	2026-03-13