HiCM-188 Heart Muscle Cell Therapy for Advanced Heart Failure During Bypass Surgery
Tests HiCM-188 cells injected into the heart during bypass surgery in adults.
Plain-language title generated from the registry record
Registry title: HiCM-188 Cell Therapy in Adults With Advanced Heart Failure Undergoing Heart Bypass Surgery
Key facts
- Where
- Houston, United StatesSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07646210, who can take part
Where in United States
- The Texas Heart Institute at Baylor College of MedicineHouston, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- HELP Therapeutics, Inc.
- Trial code
- NCT07646210
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
A Phase I/IIa, Open-Label, Dose Escalation Study to Evaluate the Safety and Tolerability of HiCM-188, an Allogeneic iPSC-derived Cardiomyocyte Therapy, in Adult Patients With Advanced Heart Failure
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.
Inclusion: 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: Left ventricular aneurysm or thrombus, except a small laminar thrombus at the site of previous myocardial infarction (MI) in a different area; Pericardial disorders or pericarditis; Primary significant organic valvular heart disease, with specified dimensions; Untreated congenital heart disease; History of left ventricular assist device surgery; Viral myocarditis; Amyloidosis; Complete atrioventricular (AV) conduction block; Other criteria apply. Please contact the investigator for more information.