HiCM-188 Cell Therapy in Adults With Advanced Heart Failure Undergoing Heart Bypass Surgery
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHELP Therapeutics Co., Ltd.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
HiCM-188 Cells
DrugHiCM-188 is an investigational allogeneic human induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy administered as intramyocardial injection during CABG surgery.
Treatment groups
12 Participants
are divided into 2 treatment groupsGroup A: HiCM-188 Low DoseExperimental treatment 1 intervention
Group B: HiCM-188 High DoseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Serious Adverse Events
Incidence of serious adverse events (SAEs) at 12 months post-transplant
Time frame
Up to 12 months post-transplantSecondary outcomes
1
Change From Baseline in Left Ventricular Ejection Fraction by Cardiac MRI
Change from baseline in left ventricular ejection fraction (LVEF, %) assessed by cardiac magnetic resonance imaging (MRI). Echocardiogram may be used as an alternative if cardiac MRI is not medically appropriate or per institutional practice.
Time frame
Baseline, 6 months, and 12 months2
Change From Baseline in Left Ventricular End-Diastolic Volume by Cardiac MRI
Change from baseline in left ventricular end-diastolic volume (LVEDV, mL) assessed by cardiac MRI. Echocardiogram may be used as an alternative if cardiac MRI is not medically appropriate or per institutional practice.
Time frame
Baseline, 6 months, and 12 months3
Change From Baseline in Left Ventricular End-Systolic Volume by Cardiac MRI
Change from baseline in left ventricular end-systolic volume (LVESV, mL) assessed by cardiac MRI. Echocardiogram may be used as an alternative if cardiac MRI is not medically appropriate or per institutional practice.
Time frame
Baseline, 6 months, and 12 months4
Change From Baseline in Infarct Size by Cardiac MRI
Change from baseline in myocardial infarct size assessed by cardiac MRI.
Time frame
Baseline, 6 months, and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov
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