Clinical Research Directory
Browse clinical research sites, groups, and studies.
hiPSC-CMs-loaded Chitosan Patch to Treat Severe Chronic Ischemic Heart Disease
Sponsor: HELP Therapeutics Co., Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2026-10-20
Completion Date
2028-10-20
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
HiCM-188 Chitosan Patch
Patients receive standard coronary artery bypass grafting (CABG) surgery plus epicardial application of two chitosan patches (each 2×4 cm in size, loaded with 5 million HiCM-188 cells), delivering a total dose of 1 × 10⁷ cardiomyocytes.
Blank Chitosan Patch
Patients receive standard CABG surgery plus epicardial application of two identical-appearing chitosan patches containing no HiCM-188 cells
Locations (1)
The Second Xiangya Hospital of Central South University
Changsha, China