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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 adverse cardiac events.
Participants will be monitored during the in-hospital period after CABG surgery and HiCM-188 administration, and then followed for up to 12 months after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HiCM-188 Low Dose | Experimental | Participants in this arm will receive a single low dose of HiCM-188, 0.5 × 10^8 cells, administered by intramyocardial injection during coronary artery bypass grafting (CABG) surgery. |
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| HiCM-188 High Dose | Experimental | Participants in this arm will receive a single high dose of HiCM-188, 1.5 × 10^8 cells, administered by intramyocardial injection during coronary artery bypass grafting (CABG) surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HiCM-188 Cells | Drug | HiCM-188 is an investigational allogeneic human induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy administered as intramyocardial injection during CABG surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Serious Adverse Events | Incidence of serious adverse events (SAEs) at 12 months post-transplant | Up to 12 months post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 months, and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alex Zhang | Contact | +1 650 504 5586 | Alex.zhang@helptx.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Texas Heart Institute at Baylor College of Medicine | Houston | Texas | 77030 | United States |
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This is an open-label 3+3 dose-escalation study. Eligible participants with advanced heart failure will be enrolled sequentially and will receive a single dose intramyocardial injection of HiCM-188 during CABG surgery. Two dose levels are planned: 0.5 × 10^8 cells and 1.5 × 10^8 cells. Dose escalation will proceed based on dose-limiting toxicity (DLT) criteria.
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| 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. | Baseline, 6 months, and 12 months |
| 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. | Baseline, 6 months, and 12 months |
| Change From Baseline in Infarct Size by Cardiac MRI | Change from baseline in myocardial infarct size assessed by cardiac MRI. | Baseline, 6 months, and 12 months |
| Change From Baseline in Myocardial Tissue Perfusion by PET/CT or SPECT | Change from baseline in myocardial tissue perfusion assessed by positron emission tomography/computed tomography (PET/CT) or single-photon emission computed tomography (SPECT). | Baseline, 6 months, and 12 months |
| Change From Baseline in 6-Minute Walk Distance | Change from baseline in exercise capacity as assessed by the 6-minute walk distance (6MWD). The 6-Minute Walk Distance is measured as the distance walked in 6 minutes, with longer distances reflecting better functional exercise capacity. | Baseline, 6 months, and 12 months |
| Change From Baseline in New York Heart Association Functional Classification | Change from baseline in New York Heart Association (NYHA) functional classification. The New York Heart Association Functional Classification ranges from Class I to Class IV, with higher classes reflecting more severe limitation of physical activity and worse heart failure symptoms. | Baseline, 6 months, and 12 months |
| Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score | Change from baseline in quality of life as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The Minnesota Living With Heart Failure Questionnaire score ranges from 0 to 105, with higher scores reflecting worse heart failure-related quality of life. | Baseline, 6 months, and 12 months |
| Incidence of Major Adverse Cardiac Events | Incidence of major adverse cardiac events (MACE) during the study follow-up period. | Up to 12 months post-transplant |