hiPSC-CMs-loaded Chitosan Patch to Treat Severe Chronic Ischemic Heart Disease
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHELP Therapeutics Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
History of permanent pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device implantation.
Severe valvular heart disease or prior prosthetic valve replacement.
Prior percutaneous coronary intervention (PCI) with stent implantation.
Chronic atrial fibrillation.
Trial design
Treatments tested in this trial
- HiCM-188 Chitosan Patch
- Blank Chitosan Patch
Treatment groups
16 Participants
are divided into 2 treatment groupsSponsors and collaborators
HELP Therapeutics Co., Ltd.
Lead sponsor
Second Xiangya Hospital of Central South University
Collaborator
Source ClinicalTrials.gov