NCT07646210
HiCM-188 Cell Therapy in Adults With Advanced Heart Failure Undergoing Heart Bypass Surgery
Not Yet Recruiting
PHASE1Ages 18–75InterventionalTreatmentHELP Therapeutics Co., Ltd.
~12 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:HiCM-188 Cells
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Serious Adverse Events
Measured over Up to 12 months post-transplant
Conditions
Where it's being run
1 sites across 1 statesTexas1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
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
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.
What this trial measures
- Incidence of Serious Adverse EventsUp to 12 months post-transplant
Incidence of serious adverse events (SAEs) at 12 months post-transplant