Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure (HEAL-AHF)

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Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Heart Failure

Treatments: Drug: HiCM-188 therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06340048

XC Liu

Details and patient eligibility

About

The purpose of this clinical study is to evaluate the feasibility, safety and efficacy of intramyocardial injection of human induce pluripotent stem cell-derived cardiomyocytes (HiCM-188) during coronary artery bypass grafting (CABG) surgery in patients with severe chronic ischemic heart failure.

Full description

This is a single center, open-label, three-group dose-escalation (phase I) study followed by dose-extension (phase IIa) study in up to 36 severe ischemic heart failure patients. It is estimated that up to 18 phase I patients will be received HiCM-188 intramyocardial injection during CABG surgery. The maximum number of subjects after dose escalation and dose extension studies in each dose group is 12. All the subjects need take immunosuppressant after transplantation.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years
2. Willingness and ability to give written informed consent
3. Nuclide-myocardial metabolic perfusion imaging or Magnetic Resonance Imaging (MRI) revealed infarcted myocardium in the left anterior descending branch (LAD) coronary artery supply area
4. LVEF<50% as assessed by Echocardiography or LVEF≤40% as assessed by MRI
5. Patients have indications for Coronary Artery Bypass Grafting

Exclusion criteria

1. Presence of a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy device (CRT)
2. Diagnosed with malignancy within 5 years
3. Autoimmune disease
4. Recipients of organ transplant.
5. Patients undergoing other surgical operations (excluding resection of ventricular aneurysm and left atrial appendage excision/occlusion).
6. Severe ventricular arrhythmia
7. Contraindication to CABG surgery
8. Contraindication to cardiac MRI or PET/CT scan.
9. Contraindication to immunosuppressants
10. Participation in another clinical trial within 3 months prior to screening
11. Pregnancy, lactation, or a positive serum pregnancy test
12. Any other condition considered by the investigator to be inappropriate for inclusion in this clinical trial

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

HiCM-188 Low dose therapy

Experimental group

Description:

Intramyocardial injection of HiCM-188 (50 million) during CABG surgery.

Treatment:

Drug: HiCM-188 therapy

HiCM-188 Medium dose therapy

Experimental group

Description:

Intramyocardial injection of HiCM-188 (150 million) during CABG surgery.

Treatment:

Drug: HiCM-188 therapy

HiCM-188 High dose therapy

Experimental group

Description:

Intramyocardial injection of HiCM-188 (450 million) during CABG surgery.

Treatment:

Drug: HiCM-188 therapy