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

NCT07471698 | Not Yet Recruiting Phase 1

• 1 other identifier: LXB
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 1.CABG + HiCM-188-loaded chitosan patch group (patch size: 2×4 cm; containing 5 million cells per patch)
2. 2.CABG + blank chitosan patch group (identical in appearance but without HiCM-188 cells).

Conditions

Ischemic Heart Failure; CABG-patients

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Change in infarct size

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

• Change in regional left ventricular function

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

• Change in regional left ventricular wall thickness

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

• Change in left ventricular end-diastolic wall thickness

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

• Change in left ventricular ejection fraction (LVEF)

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

Study Arms (2)

Control

PLACEBO COMPARATOR

Drug: Blank Chitosan Patch

Treatment

EXPERIMENTAL

Drug: HiCM-188 Chitosan Patch

Interventions

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.

Treatment

Blank Chitosan Patch DRUG

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

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Indication for coronary artery bypass grafting (CABG), meeting one of the following anatomical criteria:
• Class I Indications :
• Left ventricular dysfunction with significant left main coronary artery disease;
• Left ventricular dysfunction with "left main equivalent" disease (i.e., ≥70% stenosis in proximal LAD or proximal LCx);
• Left ventricular dysfunction with two- or three-vessel disease including proximal LAD stenosis.
• Class IIa Indication : Left ventricular dysfunction with substantial viable, akinetic but revascularizable myocardium, not covered by above Class I anatomical criteria.
• 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).
• Echocardiographic evidence of regional wall motion abnormalities (hypokinesis, akinesis, or presence of ventricular aneurysm).

You may not qualify if:

• Patients meeting any of the following criteria are ineligible for study participation:
• 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.
• History of sustained ventricular tachycardia or aborted sudden cardiac death.
• Baseline estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m².
• Hematocrit \<25%.
• Severe contrast media allergy (anaphylactic or life-threatening reaction history).
• Coagulation disorder (INR \>1.5 without therapeutic anticoagulation, platelets \<50×10⁹/L, or clinically significant bleeding diathesis).
• Known hypersensitivity to penicillin or streptomycin.
• Contraindication to undergoing cardiac MRI (e.g., incompatible implanted devices, severe claustrophobia unresponsive to premedication).
• History of solid organ or bone marrow transplantation.
• Active malignancy or history of cancer within the past 5 years (except non-melanoma skin cancer or carcinoma in situ).
• Life expectancy \<1 year due to non-cardiac conditions.

Sponsors & Collaborators

• HELP Therapeutics Co., Ltd.: lead
• Second Xiangya Hospital of Central South University: collaborator

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, China

Location

Central Study Contacts

Jiaxian Wang, MD, PhD

CONTACT

+86-18565616060; wangjx@helpsci.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start (Estimated): October 20, 2026
• Primary Completion (Estimated): October 20, 2028
• Study Completion (Estimated): October 20, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

CN (1)