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Clinical Trials in the USA / NCT07646210
Starting soon Phase 1/2

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

NCT07646210 · tracked via the Priya Life Science USA tracker
Sponsor
HELP Therapeutics Co., Ltd
Phase
Phase 1/2
Started
2026-09
Last updated
2026-06-29

Condition(s) studied

Advanced Heart FailureIschemic Heart Failure

Investigational drug(s) / intervention(s)

HiCM-188 Cells

HiCM-188 Cells: HiCM-188 is an investigational allogeneic human induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy administered as intramyocardial injection during CABG surgery.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence of Serious Adverse Events — Up to 12 months post-transplant
    Incidence of serious adverse events (SAEs) at 12 months post-transplant

Trial sites (1)

FacilityCityRegionStatus
The Texas Heart Institute at Baylor College of Medicine Houston Texas

Other trials for the same condition

CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07646210 on ClinicalTrials.gov ↗ ← All trials in the USA