HiCM-188 Cell Therapy in Adults With Advanced Heart Failure Undergoing Heart Bypass Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemic Heart Failure; Advanced Heart Failure
• Intervention / Treatment: Drug: HiCM-188 Cells

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Alex Zhang; Phone Number: +1 650 504 5586; Email: Alex.zhang@helptx.com.cn

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The Texas Heart Institute at Baylor College of Medicine
      • Principal Investigator: Emerson Perin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HiCM-188 Low Dose; 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.	Drug: HiCM-188 Cells; HiCM-188 is an investigational allogeneic human induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy administered as intramyocardial injection during CABG surgery.
Experimental: HiCM-188 High Dose; 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.	Drug: HiCM-188 Cells; HiCM-188 is an investigational allogeneic human induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy administered as intramyocardial injection during CABG surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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).	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.	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).	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

Collaborators and Investigators

• Sponsor: HELP Therapeutics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: CABG; Dose escalation; Ischemic heart failure; Advanced heart failure; Coronary artery bypass grafting; iPSC-derived cardiomyocytes; HiCM-188; Allogeneic cell therapy; Intramyocardial injection; NYHA Class III-IVa
• Other Study ID Numbers: HICM188H1101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No