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hiPSC-CMs-loaded Chitosan Patch to Treat Severe Chronic Ischemic Heart Disease

ConditionsIschemic Heart FailureCABG-patients
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • HiCM-188 Chitosan Patch

    Drug

    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

    Drug

    Patients receive standard CABG surgery plus epicardial application of two identical-appearing chitosan patches containing no HiCM-188 cells

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: ControlPlacebo comparator 1 intervention
Group B: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion and frequency of patients experiencing sustained ventricular tachycardia lasting more than 30 seconds

Time frame
1~6 Month Post-operation
2

Incidence of allogeneic human-derived tumor formation

CT scan of the abdomen and pelvis

Time frame
Baseline, 1, 3, 6 months post-operation

Secondary outcomes

1

Change in infarct size

Assessed by MRI

Time frame
Baseline, 1, 3, 6, and 12 months post-operation
2

Change in regional left ventricular function

Assessed by MRI

Time frame
Baseline, 1, 3, 6, and 12 months post-operation
3

Change in regional left ventricular wall thickness

Assessed by MRI

Time frame
Baseline, 1, 3, 6, and 12 months post-operation
4

Change in left ventricular end-diastolic wall thickness

Assessed by both MRI and echocardiography

Time frame
Baseline, 1, 3, 6, and 12 months post-operation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HELP Therapeutics Co., Ltd.

Lead sponsor

Second Xiangya Hospital of Central South University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: