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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemic Heart Failure; CABG-patients
• Intervention / Treatment: Drug: Blank Chitosan Patch; Drug: HiCM-188 Chitosan Patch

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jiaxian Wang, MD, PhD; Phone Number: +86-18565616060; Email: wangjx@helpsci.com.cn

Study Locations

• China
  • Changsha, China
    • The Second Xiangya Hospital of Central South University
    • Principal Investigator: Xiaobo Liao, MD, PhD
    • Principal Investigator: Chengming Fan, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age between 18 and 80 years (inclusive).
2. Willingness and ability to give written informed consent.
3. Chronic left ventricular dysfunction classified as Stage D (refractory end-stage heart failure) according to ACC staging criteria.
4. NYHA functional class III-IV despite optimized guideline-directed medical therapy for heart failure.

5. Indication for coronary artery bypass grafting (CABG), meeting one of the following anatomical criteria:

   5.1 Class I Indications :

   1. Left ventricular dysfunction with significant left main coronary artery disease;
   2. Left ventricular dysfunction with "left main equivalent" disease (i.e., ≥70% stenosis in proximal LAD or proximal LCx);
   3. Left ventricular dysfunction with two- or three-vessel disease including proximal LAD stenosis.

   5.2 Class IIa Indication : Left ventricular dysfunction with substantial viable, akinetic but revascularizable myocardium, not covered by above Class I anatomical criteria.

6. Left ventricular ejection fraction (LVEF) ≤40% as measured by echocardiography or cardiac MRI within 6 months prior to enrollment (excluding measurements obtained within 1 month post-myocardial infarction).
7. Echocardiographic evidence of regional wall motion abnormalities (hypokinesis, akinesis, or presence of ventricular aneurysm).

Exclusion Criteria:

Patients meeting any of the following criteria are ineligible for study participation:

1. History of permanent pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device implantation.
2. Severe valvular heart disease or prior prosthetic valve replacement.
3. Prior percutaneous coronary intervention (PCI) with stent implantation.
4. Chronic atrial fibrillation.
5. History of sustained ventricular tachycardia or aborted sudden cardiac death.
6. Baseline estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m².
7. Hematocrit <25%.
8. Severe contrast media allergy (anaphylactic or life-threatening reaction history).
9. Coagulation disorder (INR >1.5 without therapeutic anticoagulation, platelets <50×10⁹/L, or clinically significant bleeding diathesis).
10. Known hypersensitivity to penicillin or streptomycin.
11. Contraindication to undergoing cardiac MRI (e.g., incompatible implanted devices, severe claustrophobia unresponsive to premedication).
12. History of solid organ or bone marrow transplantation.
13. Active malignancy or history of cancer within the past 5 years (except non-melanoma skin cancer or carcinoma in situ).
14. Life expectancy <1 year due to non-cardiac conditions.
15. Long-term systemic immunosuppressive therapy (e.g., corticosteroids, TNF-α inhibitors).
16. Contraindications to immunosuppressive therapy (e.g., active infection, uncontrolled diabetes, peptic ulcer disease).
17. Active infectious diseases: HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis (Treponema pallidum, TP).
18. Currently participating in another interventional clinical trial.
19. Pregnant or lactating women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Drug: Blank Chitosan Patch; Patients receive standard CABG surgery plus epicardial application of two identical-appearing chitosan patches containing no HiCM-188 cells
Experimental: Treatment	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion and frequency of patients experiencing sustained ventricular tachycardia lasting more than 30 seconds		1~6 Month Post-operation
Incidence of allogeneic human-derived tumor formation	CT scan of the abdomen and pelvis	Baseline, 1, 3, 6 months post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in infarct size	Assessed by MRI	Baseline, 1, 3, 6, and 12 months post-operation
Change in regional left ventricular function	Assessed by MRI	Baseline, 1, 3, 6, and 12 months post-operation
Change in regional left ventricular wall thickness	Assessed by MRI	Baseline, 1, 3, 6, and 12 months post-operation
Change in left ventricular end-diastolic wall thickness	Assessed by both MRI and echocardiography	Baseline, 1, 3, 6, and 12 months post-operation
Change in left ventricular ejection fraction (LVEF)	Assessed by both MRI and echocardiography	Baseline, 1, 3, 6, and 12 months post-operation
Change in left ventricular end-diastolic volume (LVEDV)	Assessed by both MRI and echocardiography	Baseline, 1, 3, 6, and 12 months post-operation
Change in left ventricular end-systolic volume (LVESV)	Assessed by both MRI and echocardiography	Baseline, 1, 3, 6, and 12 months post-operation
Change in regional myocardial perfusion	Assessed by MRI	Baseline, 1, 3, 6, and 12 months post-operation
Six-minute walk test	The distance a participant can walk on a flat, hard surface in 6 minutes	Baseline, 1, 3, 6, and 12 months post-operation
New York Heart Association (NYHA) functional classification	A clinician-assessed 4-class scale (I-IV) evaluating symptom severity and functional limitation due to heart failure. Higher classes indicate greater impairment in physical activity tolerance.	Baseline, 1, 3, 6, and 12 months post-operation
Minnesota Living with Heart Failure Questionnaire (MLHFQ) score	A 21-item patient-reported outcome measure assessing health-related quality of life specific to heart failure. Total score ranges from 0 (no impact) to 105 (severe impact). Lower scores reflect better quality of life.	Baseline, 1, 3, 6, and 12 months post-operation

Collaborators and Investigators

• Sponsor: Help Therapeutics
• Collaborators: Second Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2026
• Primary Completion (Estimated): October 20, 2028
• Study Completion (Estimated): October 20, 2028

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: LXB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No