HiCM-188 Cell Therapy in Adults With Advanced Heart Failure Undergoing Heart Bypass Surgery

HELP Therapeutics Co., Ltd.

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Ischemic Heart Failure; Advanced Heart Failure

Treatments: Drug: HiCM-188 Cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT07646210

HICM188H1101

Details and patient eligibility

About

This clinical study will evaluate the safety and tolerability of HiCM-188, an investigational allogeneic induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy, in adults with advanced heart failure who are undergoing coronary artery bypass grafting (CABG) surgery.

Participants who meet the study eligibility criteria will receive a single dose intramyocardial injection of HiCM-188 during CABG surgery. The study will evaluate two dose levels of HiCM-188 using an open-label dose-escalation design. Participants will be followed for up to 12 months after treatment to monitor safety and preliminary signs of clinical effect.

Full description

This is a Phase I/IIa, open-label, dose-escalation study of HiCM-188 in adult participants with advanced heart failure. HiCM-188 is an investigational cell therapy product consisting of allogeneic human iPSC-derived cardiomyocytes intended for intramyocardial administration.

Eligible participants will receive HiCM-188 during coronary artery bypass grafting (CABG) surgery. The study uses a 3+3 dose-escalation design to evaluate two dose levels of HiCM-188: 0.5 × 10^8 cells and 1.5 × 10^8 cells. The primary objective is to evaluate the safety and tolerability of intramyocardial injection of HiCM-188. Secondary objectives include evaluation of preliminary efficacy based on cardiac function, myocardial perfusion, exercise capacity, NYHA functional classification, quality of life, and major adverse cardiac events.

Participants will be monitored during the in-hospital period after CABG surgery and HiCM-188 administration, and then followed for up to 12 months after treatment.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to sign informed consent and comply with the study protocol
• 18 to 75 years old at the time of signing informed consent
• Advanced heart failure patients with New York Heart Association (NYHA) class III to IVa despite receiving guideline-directed medical therapy (GDMT)
• Patients with an indication for coronary artery bypass grafting (CABG) per 2011 ACCF/AHA Guideline meeting a Class of Recommendation (COR) of Class I or Class IIa
• Minimum left ventricular wall thickness of ≥ 8 mm in the areas of injection, as confirmed on the screening echocardiogram (ECHO) or cardiac MRI
• Left ventricular ejection fraction (LVEF) of 20% to 45%, as confirmed on the screening echocardiogram (ECHO) or cardiac MRI
• Other criteria apply. Please contact the investigator for more information.

Exclusion criteria

• Viral myocarditis
• Amyloidosis
• Pericardial disorders or pericarditis
• Left ventricular aneurysm or thrombus, except a small laminar thrombus at the site of previous myocardial infarction (MI) in a different area
• Primary significant organic valvular heart disease, with specified dimensions
• Untreated congenital heart disease
• Complete atrioventricular (AV) conduction block
• History of left ventricular assist device surgery
• Other criteria apply. Please contact the investigator for more information.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

HiCM-188 Low Dose

Experimental group

Description:

Participants in this arm will receive a single low dose of HiCM-188, 0.5 × 10\^8 cells, administered by intramyocardial injection during coronary artery bypass grafting (CABG) surgery.

Treatment:

Drug: HiCM-188 Cells

HiCM-188 High Dose

Experimental group

Description:

Participants in this arm will receive a single high dose of HiCM-188, 1.5 × 10\^8 cells, administered by intramyocardial injection during coronary artery bypass grafting (CABG) surgery.

Treatment:

Drug: HiCM-188 Cells