HiCM-188 Cell Therapy in Adults With Advanced Heart Failure Undergoing Heart Bypass Surgery
Sponsored by HELP Therapeutics Co., Ltd.
About this study
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.
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 …
Where this study is enrolling
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The Texas Heart Institute at Baylor College of Medicine
Houston, Texas
Who can participate
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.
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Trial data sourced from ClinicalTrials.gov.